Healthy Women Today - December Recipes
This holiday season, show your friends and family that health can still come first by preparing these tasty recipes from Washington's King County Web Site. If you're still tempted to dine on high calorie foods, try taking half a serving and saving the rest for the next day or sharing with someone—it's the season for giving after all!
Garlic and Corn Risotto
Stacked Vegetable Salad
Balsamic Glazed Pearl Onions
Rosemary and Parmesan Lavasch
Sweet Potato Cookies
Cracking Down on Health Fraud - By Michelle Meadows
QUESTION OF THE WEEK - I've heard that antibiotics shouldn't be used to treat viral illnesses like colds and the flu. What should they be used for?
Antibiotics are used to treat illnesses caused by bacteria. Examples include strep throat, tuberculosis and many types of pneumonia. Taking antibiotics when they aren't needed contributes to the serious problem of antibiotic resistance. This is when bacteria have become resistant and cannot be killed by antibiotics. If the antibiotic misuse continues, some recurring infections ultimately may have to be treated with different and stronger antibiotics, leading to the possibility that eventually no antibiotic will be effective in killing the bacteria.
There are many over-the-counter products available to treat the symptoms of viral infections. These include cough suppressants to help control coughing and decongestants to help relieve a stuffy nose. Read the label and ask your pharmacist or doctor if you have any questions about which will work best for you.
To learn more about antibiotic resistance, see www.fda.gov/oc/opacom/hottopics/anti_resist.html.*
FDA Informs Public of Nationwide Recall of 500mg Strength Store-Brand Acetaminophen Caplets - The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall being conducted by Perrigo Company (Perrigo) of Allegan, Michigan for 383 lots of acetaminophen 500mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Approximately 11 million bottles containing varying quantities of acetaminophen 500mg caplets are affected by this recall. For a list of batches affected, please see www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. Consumers can determine if they are in possession of a recalled product by locating the batch number printed on the container label. A list of stores that carry store-brands potentially affected by this recall is located on FDA's website at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.
To date, there have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo. Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat. Consumers should consult their physician if they suspect they've been harmed by use of this product.
Consumers who believe they are in possession of the affected products should discontinue use immediately and call Perrigo's Consumer Affairs Department, 877-546-0454 for further instructions. Any adverse reactions experienced with the use of this product should be reported to Perrigo at the above number and the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178 or on the MedWatch website at www.fda.gov/medwatch.
FDA is currently investigating the cause of the metal particles found in the acetaminophen 500 mg. caplets. Perrigo originally informed FDA of this problem after discovering through their own regulatory quality control procedures that their tableting equipment was wearing down prematurely. The company is also investigating the cause of the problem. The ongoing investigations have revealed the presence of the metal fragments in caplets of acetaminophen, 500 mg. Perrigo reported to the FDA that 70 million caplets were passed through a metal detector; resulting in the discovery of approximately 200 caplets containing metal fragments ranging in size from "microdots" to portions of wire 8 mm in length.
At this time FDA does not anticipate that this action will cause a shortage of acetaminophen. Currently, only one strength (500 mg caplets) is affected. Consumers may wish to take additional amounts of the lower strengths of acetaminophen tablets or caplets, which are not affected by this recall, to reach the 500 mg dose or access acetaminophen produced by alternate manufacturers. In all instances, FDA advises consumers to follow labeled instructions for maximum daily dosage.
Perrigo is notifying its distributors and retailers of this issue and will inform them of steps it will take to facilitate product replacement.*
Atenolol vs Losartan Clinical Trial Update - The Pediatric Heart Network is very excited about this upcoming clinical trial and is working hard to finalize study drug issues and obtain the required approvals from the FDA and individual trial sites. We think enrollment will begin in late December or early January, 2007.
You can find information about the trial on the Pediatric Heart Network website at http://www.pediatricheartnetwork.org/marfanforparents.asp. The website has brochures about the trial, including an overview of what will happen during the trial. The website also has at this link http://www.pediatricheartnetwork.org/marfanwhotocontact.asp a list of the trial sites and whom to contact at each site. The attached WORD file is also a list of the trial sites with contact information.
At this time you may select the center of your choice and call the contact person for more information. By contacting the site now, the research team will know you are interested in being in the trial. They will contact you when the trial is ready to start actual enrollment.
Each trial site will handle all enrollment activities. The research team at the site of your choice will help decide whether you or your child is eligible to participate and will answer all of your questions about the trial.
When the 18 centers are ready to accept enrollment, the NMF will mail you another update and will also put information on the NMF website.
We know that many of you are eager to see the clinical trial begin and we look forward to a successful clinical trial.
Healthy Women Today - November Recipes:
In addition to one of the biggest food related holidays this month (think turkey and pumpkin pie!), November is also American Diabetes Month. We've put together some Healthy Recipes from the American Diabetes Association for everyone at your table this year!
People with diabetes have to take extra care to make sure that their food is balanced to help manage their blood glucose levels. When you make healthy food choices, you will improve your overall health and you can even prevent conditions such as heart disease, some cancers, and hypertension.
Even if there isn't anyone in your family who is a diabetic, feature some of these recipes around your Thanksgiving Day table this year in recognition of the 20 million Americans who have diabetes—about half of whom are women.*
Cranberry Lime Punch
Basic Bread Stuffing
FDA Approves New Treatment for Diabetes -
First in a New Class of Diabetes Drugs - The Food and Drug Administration (FDA) announced today the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DPP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar.
FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control.
"For the millions of Americans with type 2 diabetes, who continue to have inadequate blood sugar control, the approval of Januvia marks an important advance in the fight against diabetes," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels."*
FTC and FDA Act Against Internet Vendors of Fraudulent Diabetes Cures and Treatments - Measures are Part of Coordinated Effort by United States, Mexico and Canada
The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA), working with government agencies in Mexico and Canada, have launched a drive to stop deceptive Internet advertisements and sales of products misrepresented as cures or treatments for diabetes. The ongoing joint campaign has so far included approximately 180 warning letters and other advisories sent to online outlets in the three countries.
“We will continue working with our partners in the U.S. and internationally to make sure scammers have no place to hide,” said Lydia Parnes, Director of FTC’s Bureau of Consumer Protection. “The Internet can be a great source of information, but it also is a billboard for ads that promise miracle cures for diabetes and other serious diseases. Our advice to consumers: ‘Be smart, be skeptical’ when evaluating health claims online.”
“We will not tolerate practices that raise false hopes and bilk consumers of precious health care dollars,” said Margaret O’K. Glavin, FDA’s Associate Commissioner for Regulatory Affairs. “Diabetes requires effective treatments and aggressive management, not bogus and unproven products.”
The joint diabetes initiative to stop commercial sale of fraudulent therapies originated with a Web surf for “hidden traps” by the International Consumer Protection and Enforcement Network (ICPEN), an organization of law enforcement authorities, members of the Mexico, United States, and Canada Health Fraud Working Group (MUCH), and the attorneys general offices of Alaska, Michigan, Ohio, Virginia, and Wisconsin. MUCH, which consists of regulatory officials from health, consumer and competition protection agencies in the three North American countries, had previously conducted a campaign against fraudulent weight-loss products.
Using the results of the Internet sweep, FTC sent warning letters for deceptive ads to 84 domestic and 7 Canadian Web sites targeting U.S. consumers, and referred an additional 21 sites to foreign governments. About a quarter of the firms have already changed their claims or removed their pages from the Internet, and several others are in contact with FTC.
Today, FDA announced it has issued warning letters to 24 firms marketing dietary supplement products with claims to treat, cure, prevent or mitigate diabetes (see link to Warning Letters at http://www.cfsan.fda.gov/~dms/dialist.html ). The FDA letters warn firms that failure to promptly correct the violations may result in enforcement action without further notice, which may include seizure of violative products and/or injunctions against the manufacturers and distributors.
FTC is also announcing today a new consumer education campaign to teach consumers how to avoid phony diabetes cures. The materials encourage consumers to “Be smart, be skeptical!” and will be available in English, Spanish, and French (see [Web link]. One component is a “teaser” Web site available at http://wemarket4u.net/glucobate/index.html. At first glance, the site appears to be advertising a cure for diabetes called Glucobate, but when consumers click for more information on ordering the product, it reveals information about avoiding ads for phony cure-alls in the future. The new education materials, including a bookmark and consumer alert, are being introduced in time for Diabetes Awareness Month in November. The American Dietetic Association has agreed to help disseminate the information.*
Gene Variation Affects Pain Sensitivity and Risk of Chronic Pain - Finding May Lead to New Treatments
A new NIH-funded study shows that a specific gene variant in humans affects both sensitivity to short-term (acute) pain in healthy volunteers and the risk of developing chronic pain after one kind of back surgery. Blocking increased activity of this gene after nerve injury or inflammation in animals prevented development of chronic pain.
The gene in this study, GCH1, codes for an enzyme called GTP cyclohydrolase. The study suggests that inhibiting GTP cyclohydrolase activity might help to prevent or treat chronic pain, which affects as many as 50 million people in the United States. Doctors also may be able to screen people for the gene variant to predict their risk of chronic post-surgical pain before they undergo surgery. The results appear in the October 22, 2006, advance online publication of Nature Medicine.
"This is a completely new pathway that contributes to the development of pain," says Clifford J. Woolf, M.D., of Massachusetts General Hospital and Harvard Medical School in Boston, who led the research. "The study shows that we inherit the extent to which we feel pain, both under normal conditions and after damage to the nervous system."*
Life is full of ups and downs. But when the down times don't seem to end, or keep you from feeling "normal," you may be suffering from depression. Depression is a medical illness that involves both the body and mind. It affects the way you eat and sleep, the way you feel about yourself, and the way you think about things.
October 5th is National Depression Screening Day—a day when those who are concerned about depression can get the help they need. Activities around the country include both in-person and online programs for depression, bipolar disorder, generalized anxiety disorder, post-traumatic stress disorder, eating disorders, alcohol problems, and suicide prevention. Read more about different types of depression and how they can affect those you love:
ADHD Medication Misuse by Those Aged 12 to 17 Results in Higher Number of Visits to Emergency Department.
Clinical Trial Shows Islet Transplantation is a Promising Procedure For Certain Patients with Severe Type 1 Diabetes
The first international, multicenter trial of the Edmonton Protocol — a standardized approach to the transplantation of insulin-producing islets — demonstrates that this may be an appropriate therapy that can dramatically benefit certain patients with severe complications of Type 1 diabetes mellitus.
As described in the September 28, 2006 issue of The New England Journal of Medicine, 36 adult volunteers at nine clinical trial sites in North America and Europe received up to three infusions of islets, which are non-functioning in people with Type 1 diabetes. The trial was designed to gauge how well the transplanted islets would function in regulating blood sugar levels.
Led by James Shapiro, M.D., Ph.D., of the University of Alberta, Edmonton, Canada, and involving an international team of islet transplant researchers, this trial was conducted by the Immune Tolerance Network (ITN). Headquartered at the University of California, San Francisco, the ITN is an international consortium of clinical investigators supported by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Juvenile Diabetes Research Foundation (JDRF). NIAID and NIDDK are both components of the National Institutes of Health (NIH).
“The results of the trial show the feasibility and reproducibility of islet transplantation using the Edmonton Protocol and has promising implications for the future of treating type 1 diabetes,” says NIH Director Elias A. Zerhouni, M.D.
A year after the final treatment, 44 percent of the transplant recipients no longer needed insulin injections, and an additional 28 percent had partial islet function, which was associated with resolution of hypoglycemic unawareness — a severe complication of diabetes in which people can no longer recognize early symptoms of low blood sugar. Insulin independence did not persist indefinitely in most cases, and less than a third of the people who had been freed from insulin after one year remained so by two years. However, individuals with functioning islets had improved control of their diabetes, even though they still needed to take insulin shots. Further research will be needed to improve and prolong the beneficial effects of the procedure, the researchers say.
“Dr. Shapiro and the ITN research team have improved our understanding of the potential of islet transplantation for certain patients with Type 1 diabetes,” says NIAID Director Anthony S. Fauci, M.D. “Ongoing studies will further define the clinical utility of this approach.”
“This really shows that islet transplantation can be tremendously successful in protecting against hypoglycemic unawareness,” says Dr. Shapiro.*
Statins given before heart surgery may lower post-surgery risks - American Heart Association rapid access journal report
A cholesterol-lowering drug given before heart bypass surgery or surgical repair of a faulty heart valve may reduce a common heart rhythm disturbance that these surgeries often trigger, according to research reported in Circulation: Journal of the American Heart Association.
Successful heart surgery or valve repair often triggers atrial fibrillation (AF), an irregular heartbeat that increases risk of stroke, heart failure and death and increases the length of stay in the hospital.
“Daily treatment with 40 mg of atorvastatin (Lipitor) for seven days before heart surgery reduced the risk of postoperative AF by 61 percent compared to patients who received a placebo for seven days,” said Giuseppe Patti, M.D., lead author of the study and assistant professor of cardiology in the Department of Cardiovascular Sciences at Campus Bio-Medico University in Rome, Italy.
Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the body’s production of cholesterol.
“It is possible that the benefit is due to a class effect (anti-inflammatory or antioxidant actions, direct anti-arrhythmic effects or direct myocardial protection) of statin therapy, but this has to be confirmed in randomized ad hoc protocols with other statins,” Patti said.*
FDA Warns Consumers Not to Buy or Use Prescription Drugs from Various Canadian Websites that Apparently Sell Counterfeit Products - The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase prescription drugs from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada following reports of counterfeit versions of prescription drug products being sold by these companies to U.S. consumers. FDA is investigating these reports and is coordinating with international law enforcement authorities on this matter.
FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market. Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia.
Some of the websites that are operated by Mediplan or that have order fulfillment through Mediplan are:
Healthy Women Today's September Recipes - Our bodies need cholesterol to function normally. But, if you have too much cholesterol in your blood, it can build up in your arteries and can cause heart disease, the #1 killer of women and men. Here are some recipes that you can enjoy that are high on taste and low in cholesterol!
National Marfan Foundation Newsletter Request for NMF Volunteers in TX, TN, and IL:
As you may know, the National Marfan Foundation regularly travels to medical conferences and has a booth in the exhibit hall. This affords the NMF a great opportunity to meet with health professionals involved in diagnosing and treating Marfan syndrome while they are in "learning mode." We generally have an NMF staff person on site working with local volunteers to staff the booth for the duration of the conference.
We have three such exhibits coming up, and are currently seeking well spoken individuals who are knowledgeable about Marfan syndrome who are able help out. People who have done this in the past have commented that it is a great way to see up close some of the great work we are doing to educate the medical community about Marfan syndrome and the NMF. If you are available for any of the conferences listed below, please contact me A.S.A.P. to see if this opportunity may be a good match for you. Please keep in mind that we may have to limit the number of volunteers for any given time-- I will create a schedule based on response and availability. (Sorry, no one under 18 years old is allowed in most exhibit halls.)
Emergency Nurses Association
San Antonio, TX
Thursday, September 14th, 4-7pm
Friday, September 15th, 9am – 1pm
Saturday, September 16th, 9am – 1pm
National Society of Genetic Counselors
Friday, November 10th, 6:30-8:30p
Saturday, November 11th, 11a-5p
Sunday, November 12th, 10a-4p
Monday, November 13th, 10a-2:30p
American Heart Association
Sunday, November 12th, 9a-5p
Monday, November 13th, 9a-5p
Tuesday, November 14th, 9a-5p
If you are available during any of the times listed above, and are within driving distance of any of the cities, please let me know. I would be happy to answer any questions about the requirements for volunteers.
Jonathan Martin, MS
Director of Education and Public Awareness Programs
National Marfan Foundation
22 Manhasset Avenue
Port Washington, NY 11050
(800) 8-MARFAN or (516) 883-8712 x. 16*
Figuring Out Health News - Jordan was gathering information for a research project on teens and suicide. She came across a news article about how some antidepressants increase the chances of suicidal thinking and behavior in kids and teens. Jordan was confused. How could a medicine that was supposed to help kids with depression actually make them feel worse? She was also worried because her sister was taking an antidepressant. After Jordan did some of her own research and looked into the issue further, though, she discovered things that set her mind at ease.
Often, news reports on health and medicine can be confusing — and sometimes they can be downright scary. How do you know what is important and accurate?
Large newspapers, magazines, TV networks, and radio stations often have medical reporters on staff to cover developments in health and medicine. Their job is to report complicated scientific information in a way that’s easy for regular people to understand. Many health stories are accurate and balanced. But not all are. Sometimes, reporters try to quickly cram information into a short news story, and they may oversimplify the information. What you see may not be the whole picture.*
Healthy Women Today's June Recipes (OK, so I'm late...Shoot me!) - Eating to lower your cholesterol might not be something you think about every day. But it could be one of the most important things to consider because high cholesterol can lead to heart disease — the number one killer of women and men! These recipes can be easily incorporated into any healthy eating plan!
Bran Muffins with Pineapple and Dried Cranberries
Green Beans with Red Bell Peppers, Pine Nuts, and Fresh Basil
Grilled Curry-Rubbed Salmon with Papaya Salsa*
FDA Approves First Generic Venlafaxine - The Food and Drug Administration today approved the first generic version of Effexor (venlafaxine), an important step in the agency's effort to increase the availability of lower-cost generic medications. Venlafaxine is indicated for the treatment of major depressive disorder (MDD).*
Preventing Errors with Tablet Splitting - Splitting tablets is a common practice where tablets of a higher strength than the patient needs are broken in half, or even quarters, to provide the correct dose. This is often done to reduce costs, since the higher strength tablet sometimes costs about the same as the lower strength one. In some cases the hospital may not stock the lower strength of a particular medication, and in other cases the patient may not be able to swallow a whole tablet.
But unless certain precautions are taken, tablet splitting can lead to medication errors. If the patient is splitting the tablets at home, he or she can become confused about the dose. Patients often forget to split their tablets, or they can split them again after they've been pre-split in the pharmacy. Some patients may not have the visual acuity or motor skill to do the splitting properly. Even when split well, the pieces can crumble or be uneven in size.
Patients may not be the only possible source of error. When the prescription is written as "1/2 tablet," the pharmacist can confuse this with "1-2 tablets," which could lead to a fourfold overdose.*
Read The Whole Article...
Medicines In My Home - Welcome to Medicines in My Home, an interactive and educational program about the safe and effective use of over-the-counter medicines. This program was developed by the Food and Drug Administration with Maryland's Montgomery County Public School system and in cooperation with the National Council On Patient Information and Education.*
FDA Warns Consumers Against Drinking High-Strength Hydrogen Peroxide for Medicinal Use - Ingestion Can Lead to Serious Health Risks and Death - The U.S. Food and Drug Administration (FDA) is warning consumers not to purchase or to use high-strength hydrogen peroxide products, including a product marketed as "35 Percent Food Grade Hydrogen Peroxide," for medicinal purposes because they can cause serious harm or death when ingested. FDA recommends that consumers who are currently using high-strength hydrogen peroxide stop immediately and consult their health care provider.
FDA is working to stop companies selling high-strength hydrogen peroxide from making illegal medical claims about their products. These claims are illegal because these products do not have FDA approval and are therefore being sold illegally for medical indications without any proven clinical value. The products can instead cause significant harm. As part of these ongoing efforts, FDA today issued Warning Letters to two firms illegally selling "35 percent hydrogen peroxide" products on Web sites for the treatment of AIDS, cancers, emphysema, and other serious and life-threatening diseases. These Warning Letters are available on FDA's Web site, at http://www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm.*
May-June Issue of FDA Consumer Magazine
QUESTION OF THE WEEK - What precautions should be taken regarding food safety in the home following a hurricane or flood?
Read more about Hurricanes: Health and Safety Before and After a Storm.*
Another Marfan In The News Update: - The Marfan syndrome segment on Paula Zahn Now (CNN) is now scheduled for Wednesday, May 17. The program airs from 8-9 Eastern time. Check local listings.
It was bumped from Monday night because of the president's speech on immigration.*
Director of Communications
National Marfan Foundation
FDA MedWatch - Paxil/Paxil CR (paroxetine HCl) and recent meta-analysis of paroxetine showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo
GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil and Paxil CR. These labeling changes relate to adult patients, particularly those who are younger adults.
A recent meta-analysis conducted of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders. Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo. Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution. All of the reported events of suicidal behavior in the adult patients with MDD were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.
It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated.
Read the complete MedWatch 2006 Safety Summary, including links to the Dear Healthcare Professional Letter and the revised approved product labeling at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#paxil*
Marfan In The News Update: - Good morning. I learned late yesterday that the segment will not air on CNN tonight. Instead, it may run tomorrow night (May 12) or Monday night (May 15). The producer is pushing for Monday night. I will let you know if this changes yet again.*
Director of Communications
National Marfan Foundation
Marfan In The News - From a recent e-mail by Eileen Masciale, Director of Communications, National Marfan Foundation - "The" Marfan syndrome will be featured on a segment on CNN’s Paula Zahn Now, which airs at 8 pm Eastern (check local listings for time in your area). Those featured in the segment include NMF members Karen and Michael Murray (New York), the Nemchek family (California) and Dr. Hal Dietz (Johns Hopkins). The NMF is grateful for all the time and effort these individuals/families dedicated to the shooting of this segment.
As of today, the segment is scheduled to air on Thursday night, May 11. However, this has been changing and still can change over the next few days. We will notify you of any changes, if possible.
Check your listings, set your TIVO or your VCR.
We anticipate a great response to this segment and hope we reach a lot of people who can benefit from the NMF’s support, information and research. Please tune in!*
IBM's Search Engine Sifts Drug Trial Info - Patients and doctors hunting for information about marketed and experimental therapies should now have an easier time, according to the International Federation of Pharmaceutical Manufacturers & Associations.
On March 22, IFPMA launched an Internet search engine that finds information from a collection of databases and allows searchers to input criteria in five languages.
Both medicines and diseases are known by a variety of names, both across geographical regions and medical specialties, so searches that use only one term can routinely miss relevant information.
The clinical trials portal automatically expands search terms to cover synonyms in medical jargon and other languages and even helps correct misspelled words.
Patients and physicians can also look for trials under way near where they live and learn about the criteria for participating.
IFPMA's clinical trials portal will not host data itself, said Harvey Bale, Director General of the IFPMA. Instead, it will comb through available databases.
"It doesn't replicate a single thing that's being done elsewhere," said Bale. "It brings under one roof a variety of information that was elsewhere only at separate sites."
Currently, the portal links to some 15 sites, including clinicaltrials.gov, centerwatch.com, and clinicalstudyresults.org. Over 88,000 pages have been indexed. The number of sites and indexed pages are both expected to grow.*
The Healthy Women Today Newsletter for May 2006 is Available:
National Women's Health Week is finally here — May 14th-20th — and hundreds of events are already listed on the web site. Plan something to help educate your community about a women's health issue and encourage people to attend by registering online today!
Kick off the week by taking part in the nation's largest preventive care check-up event, National Women's Check-Up Day on Monday, May 15th. Community health centers, hospitals, and other health care providers across America will participate in this event by offering preventive health screenings to women.*
Health Article for May, 2006 - A Breath Away: Daughters Remember Mothers Lost to Smoking
Leah Larson - Creating a Voice for Girls in America and Around the World - There is a new Spotlight shining on girlshealth.gov and it's shining on Leah Larson. Have you ever wanted your voice heard by thousands of people around the world? Leah Larson wanted to give Jewish girls a voice, so she started a magazine called "Yaldah" (the Hebrew word for girl). Talk about getting the word out! Meet Leah and learn about what makes her shine in our Spotlight!*
Focus on You - We received an e-mail from a woman with a newborn baby. She had been feeding her baby formula but wanted to switch to breastfeeding. She was concerned that she might not have enough breast milk to feed the baby and wanted to know if it would be a problem to switch from one method of feeding to the other.* Read The Whole Article...
May's Featured Health Topic: Anxiety Disorders
The Minds and Hearts of Soldiers, Sailors, Airmen, Marines and their Families - Over 200,000 of today’s military are presently deployed in the war against terrorism in Iraq and Afghanistan. We often forget that this deployment is but one of many for our military and their families, a community often seen as a part of but apart from the rest of the nation. On the home front deployment is also a part of response to natural disasters. For Hurricane Katrina, the military deployed 72,000 forces including 50,000 National Guard as well as Navy ships and helicopters. Deployments abroad as well as deployments at home affect our nation’s families and soldiers across the country.
Whether in the extreme environments of combat or peacekeeping or on humanitarian missions, the stress of such work can be great. Soldiers and their families exhibit resilience in abundance. But military men, women and their families also experience apprehension with departure for these missions, stress from the added responsibilities and new family roles during deployment as one parent must now be caretaker and parent. And there is even stress in reuniting after long periods apart and refinding each other and new jobs and occupations, and for some anticipating redeployment in the not distant future. For some few, soldiers and families must also deal with serious injuries and loss of loved ones – events that alter lives forever. But we must not forget that resilience is also part of mental health.* Read the whole article...
An APA expert answers common questions about Mental Health Month - A recent survey by the American Psychiatric Association (APA), conducted in observance of May as Mental Health Month, found a significant lack of consumer knowledge and understanding about the warning signs, causes, and effective treatments for mental illnesses, such as depression. Almost half the public—44 percent—report knowing only a little or almost nothing at all about mental illnesses. But asked whether they would benefit from knowing more about the warning signs of mental illness, 84 percent said yes.*
FDA Approves First Generic Pravastatin - The Food and Drug Administration today approved the first generic version of Bristol-Myers Squibb's Pravachol (Pravastatin Sodium Tablets), an important step in the agency's effort to increase the availability of lower-cost generic medications.
Pravastatin is indicated for the treatment of individuals with high cholesterol levels (hyperlipidemia) or who are at increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke in which high cholesterol levels are a factor. In 2005, Pravachol was the 22nd highest-selling brand-name drug in the United States, with sales totaling $1.3 billion.
"This approval is another example of our agency's endeavor to counter rising health care costs by approving safe and effective generic alternatives as soon as the law permits," said Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs. "Pravastatin is a widely-used cholesterol-lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease."*
It’s articles like these that scare the hell-outta-me! I normally only post things that are somewhat relevant to my own personal health/medical issues, but when I saw these two warnings, I feel I gotta report them in hopes that someone who may benefit from this info will see it. And, of course, I also hope that others are subscribing to, and reading, the FDA MedWatch Newsletters.
Promethazine HCl (marketed as Phenergan and generic products): All forms including syrup contraindicated in children less than 2 years - FDA notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old. Parents and caregivers should also be careful and get a doctor's advice about giving promethazine HCl in any form to children age two and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.* (My Emphasis.)
Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals - FDA and NIOSH (National Institute for Occupational Safety and Health) notified healthcare professionals that twelve incidents have been reported in which regulators used with oxygen cylinders have burned or exploded, in some cases injuring personnel. Some of the incidents occurred during emergency medical use or during routine equipment checks. FDA and NIOSH believe that improper use of gaskets/washers in these regulators was a major factor in both the ignition and severity of the fires, although there are likely other contributing factors. FDA and NIOSH recommend that plastic crush gaskets never be reused, as they may require additional torque to obtain the necessary seal with each subsequent use. This can deform the gasket, increasing the likelihood that oxygen will leak around the seal and ignite.*
NMF News: Important Breakthrough Research for Marfan Syndrome - The National Marfan Foundation (NMF) is excited to announce an important breakthrough in Marfan research which was published yesterday in Science.
Scientists at Johns Hopkins have used a blood pressure medicine already on the market, losartan (Cozaar), to prevent a potentially fatal weakening of arteries in mice with Marfan syndrome. The findings are considered a breakthrough discovery because they are the first to identify a drug that can prevent Marfan syndrome's most life-threatening complications from developing and potentially reverse the damage already done. The NMF is proud to have been one of the funders for this study.
Based on the successful studies in the mouse models, the researchers and the NMF have worked with the National Heart, Lung and Blood Institute (NHLBI) and its affiliated network of hospitals in the Pediatric Heart Health Network to begin a clinical trial for people with Marfan syndrome, which is expected to start in the fall. The NMF has promised to collaborate with NHLBI on patient recruitment and support throughout this trial. In addition, the NMF would like to support complementary studies to the clinical trial to explore potential effects on other body systems.
The NMF is very excited about these findings and we are eager to begin the clinical trial this fall. Please visit the NMF website HERE for more information about the clinical trial and how you can participate. If you have any questions or would like to help the NMF financially support these efforts please contact Dr. Josephine Grima at the NMF at email@example.com.
We will be sure to keep you posted of any progress made.
President & CEO
National Marfan Foundation*
Investigation of Serious Eye Infections Associated With Soft Contact Lens Use and Contact Lens Solution - Consumers Are Advised to Follow Good Hygiene Practices and Manufacturers’ Instructions to Prevent Infection
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are alerting health care professionals and their patients who wear soft contact lenses to an increasing number of reports in the United States of rare but serious fungal infections in the eye that can cause permanent loss of sight. Some patients have reported a significant loss of vision, resulting in the need for a corneal transplant.
A fungus called Fusarium has been identified as the cause of the reported infections. As of April 9, 2006, 109 cases of suspected Fusarium keratitis are under investigation by CDC and public health authorities in 17 states of the U.S.
"This is a serious infection and soft contact lens users should be mindful of the potential to develop this problem," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "We're advising consumers to practice good basic hygiene and follow manufacturers' instructions for proper use, cleaning and storage of their lenses, and report any signs of infection to their doctors."
Of the 30 patient cases fully investigated so far, 28 wore soft contact lenses and two reported no contact lens use. Twenty-six of the soft contact lens users who remembered which solution they used during the month prior to the infection onset reported using a Bausch & Lomb ReNu brand contact lens solution or a generic brand manufactured by the same company. Five case-patients reported using other solutions in addition to the ReNu brand, and 9 patients reported wearing contact lenses overnight, a known risk factor for microbial keratitis.
"It is important to note that some of the affected patients had used other solutions in addition to the ReNu brand, and that the source of this fungus has not yet been identified. But we're working with CDC and Bausch & Lomb -- and we're investigating other possible causes -- to prevent these infections," Dr. Schultz added.
Bausch and Lomb has informed FDA that they are voluntarily stopping shipment of the ReNu Moisture Loc product while they are continuing to investigate the cause of these infections. Soft contact lens users who have existing supplies of the Renu Moisture Loc should use the product with caution and report any signs and symptoms of eye infection to their doctors.*
FDA Statement Regarding Voluntary Market Withdrawal of Bausch & Lomb ReNu MoistureLoc® Contact Lens Solution
FDA is continuing to work closely with the Centers for Disease Control and Prevention (CDC) and Bausch & Lomb to investigate the source of Fusarium keratitis eye infections. The agency supports Bausch & Lomb's decision to voluntarily withdraw ReNu MoistureLoc® contact lens solution from the market until the agencies have had a chance to conclude their investigation.
FDA started its investigation of the Bausch & Lomb manufacturing plant on March 22, 2006, and will continue inspections of the Greenville, SC manufacturing plant and other facilities through next week. While the investigation continues, FDA will work with CDC to identify and confirm cases of
Safety-related drug labeling changes for January 2006 - The January 2006 posting includes 60 drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections.
The Summary page -- http://www.fda.gov/medwatch/SAFETY/2006/jan06_quickview.htm -- provides drug names and a listing of the sections changed.
The Detailed view -- http://www.fda.gov/medwatch/SAFETY/2006/jan06.htm -- includes sections/subsections changed and a description of new or modified safety information in the Boxed Warning, Contraindications, or Warnings sections. The full labeling may be accessed by clicking on the drug name in the detailed view.*
Proper Use of Fentanyl Pain Patches - Fentanyl skin patches provide convenient and effective relief for many people who experience chronic pain, and who have been taking pain medications for long periods of time. But health care providers and patients should be aware that deaths and other serious problems have resulted from accidental overdoses related to inappropriate use of the fentanyl patch, the Food and Drug Administration says.*
Girlshealth.gov has teamed up with New Moon magazine to give FREE access to articles written for girls by girls. There are three new articles added to the collection. Learn about the ingredients in junk food, how to play it safe in a sticky situation, and more! We picked these articles because they are all about being healthy and having fun. http://www.girlshealth.gov/news/newmoon.htm*
April Recipes - It's April — and for many of us, that means our kids are on spring break. You're probably in need of a little spring break of your own! We're giving you some spicy, healthy recipes that will make you think you're sitting on a beach somewhere south of the border!*
April's Featured Health Topic: Violence - Violence and abuse affect all kinds of people every day. It doesn't matter what race or culture you come from, how much money you have, or if you have a disability. It is most common among women between ages 15 and 54, but it can happen at any age.
In recognition of A Day to End Sexual Violence, we want to help you learn more about how to recognize the signs of violence and abuse and stay safe. If you are being abused or have a loved one who is being abused, or if you even think there is abuse, get help as soon as you can. Remember abuse can be physical, mental, or emotional.*
Audience: Reproductive healthcare professionals and consumers
The FDA notified healthcare professionals of two additional deaths following medical abortion with mifepristone (Mifeprex). The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories. At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death. However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment. In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation.*
MEDICARE BENEFICIARIES URGED TO BE ON THE LOOK-OUT FOR PHONE SCAMS - The Centers for Medicare & Medicaid Services (CMS) warns seniors and people with disabilities to be aware of a scheme that asks Medicare beneficiaries for money and checking account information to help them enroll in a Medicare Prescription Drug Plan.
This scheme is called the “$299 Ring” for the typical amount of money Medicare beneficiaries are talked into withdrawing from their checking accounts to pay for a non-existent prescription drug plan. Consumers can report these cases to their local law enforcement agencies or 1-877-7SAFERX (1-877-772-3379).*
Sign Language - American Sign Language is a rich language of gestures and hand symbols. Each gesture represents either a concept, a word or a letter. In those cases where a gesture doesn't exist for a particular idea, a word can be spelled out, letter by letter, using finger spelling. Want to learn some sign language? Better than a printed book, the following sites use animation and movies to illustrate the many subtleties of signing.*
FDA Advisory Committees - What do FDA advisory committees do? How can I find out when they meet? - FDA enlists non-government experts from across the country to help the agency reach decisions, particularly concerning controversial issues or new and unusual products. These "advisory committees" consist of medical professionals, scientists, researchers, industry leaders, consumers, and patients.
To learn more about advisory committees, and to see a list of meeting dates, go to http://www.fda.gov/oc/advisory/default.htm.*
Public Warned about Identity Theft E-mail Scam - The Agency has received several reports of an email message being circulated addressed to “Dear Social Security Number And Card owner” and purporting to be from the Social Security Administration. The message informs the reader “that someone illegally is using your Social Security number and assuming your identity” and directs the reader to a website designed to look like Social Security’s Internet website.*
If y'all ever receive an e-mail that "looks" like it came from a trust-worthy organization and it's asking for personal information, DO NOT CLICK ON THE LINKS!!! More likely than not it's a fake e-mail created to steal personal information from you! If you just MUST find out for yourself it something stated in the e-mail is true or not, open a new Browser Window on your own and TYPE in the URL yourself and then visit the site and look for related information. At least that way you won't be re-directed to a fake web site using fake URL's created by scammers.
FDA issued a public health advisory and other advisory information to notify both healthcare professionals and consumers of recently published studies of serious renal and cardiovascular toxicity following Trasylol administration to patients undergoing coronary artery bypass grafting surgery (CABG). An observational study published in The New England Journal of Medicine reported that Trasylol may be associated with increased risk of myocardial infarction, stroke and renal dysfunction. Another publication (Transfusion, on-line edition, January 20, 2006) has reported that Trasylol administration may increase the risk for renal toxicity.
The FDA is working with the authors of the publications and the manufacturer of Trasylol to carefully evaluate the risks and benefits associated with use of Trasylol in CABG. The FDA anticipates the public presentation of the recently reported information and other data at an advisory committee in the near future. The FDA will notify health care providers and patients in a timely fashion as new information becomes available.
Read the complete MedWatch 2006 Safety summary, including links to the Public Health Advisory and supporting documents, at:
FDA News Digest February 6, 2006
FDA News Digest January 30, 2006
NWHIC's Healthy Women Today newsletter for February 2006 is now available:
Important News from NWHIC & OWH
FDA News Digest January 17, 2006
-- New Guidelines Aim to Boost Early Phases of Drug Development
-- FDA Warns of Confusing Drug Names in Prescriptions Filled Abroad
-- Lipodrene Seized; Contained Prohibited Ephedrine Alkaloids
-- Whole Foods Market's Whole Catch Lemon Pepper Garlic Hot Smoked Trout
-- Log House Cherry Flavored Chips, Log House Butterscotch Flavored Chips, and Hy-Vee Butterscotch Flavored Chips
-- Robert's American Gourmet Wheat Free Chaos Snack Mix; 6-oz. bags
-- FDA is warning consumers not to use Emagrece Sim Dietary Supplement (also known as the Brazilian Diet Pill), and Herbathin Dietary Supplement
Upcoming Public Meetings
Question of the Week - Can the symptoms of foodborne illness be mistaken for the flu?
Yes. Foodborne illness often causes flu-like symptoms such as nausea, vomiting, diarrhea, or fever, so many people may not recognize that the illness is caused by bacteria or other pathogens in food. Experts from the Centers for Disease Control and Prevention (CDC) report that many of the intestinal illnesses commonly referred to as stomach flu are actually caused by foodborne pathogens. People do not associate these illnesses with food because the onset of symptoms often occurs two or more days after the contaminated food was eaten.*
For more on foodborne illness, see http://www.cfsan.fda.gov/~mow/foodborn.html
National Women’s Health Week and Check Up Day - Have you started thinking about your New Year’s Resolutions? Be sure to include National Women’s Health Week in your plans for making 2006 the healthiest yet! The week will begin on Monday, May 15, 2006 with our largest preventive care check-up event, National Women's Check-Up Day. Check the NWHIC web site for more information.*
Medicare Prescription Drug Coverage: What It Means To You - Medicare will offer prescription drug coverage to all people with Medicare beginning January 2006. If you're curious about the new Medicare Prescription Drug Coverage program and its importance, you'll want to read more.*
January Featured Health Topic - You probably think about how healthy your weight is every day. But what you may not consider is the health of your cervix. Unlike an expanding waistline, you can’t see your cervix, so it’s probably not the first thing you think of in the morning. Read more about the resources that we have on womenshealth.gov about cervical health in our featured health topic section!*
January Recipes - One of the most popular New Year’s Resolutions is to lose weight. Start this year out on the right foot by cooking up some of these recipes from the Library of Congress’ online recipe book, “The Great American Potluck.”*
January's Featured Health Article - Dr. Bobbie S. Gostout, a gynecologic oncologist, sees countless women who all wish for one thing. That they’d been screened for cervical cancer early on—when it’s more easily treated. Each year cervical cancer kills about 3,700 women. Read her article on what you can do to help prevent cervical cancer and ensure a healthy cervix.*
FDA Warning on Antidepressants Challenged by "Suicide Risk During Antidepressant Treatment" Study article by the American Psychiatric Association. (Adobe Acrobat Reader needed)
FDA Operation Reveals Many Drugs Promoted as "Canadian" Products Really Originate From Other Countries
An FDA operation found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with "Canadian" pharmacies. Of the drugs being promoted as "Canadian," based on accompanying documentation, 85 percent actually came from 27 countries around the globe. A number of these products also were found to be counterfeit.
“This operation suggests that drugs ordered from so-called ‘Canadian’ Internet sites are not drugs of known safety and efficacy,” said Dr. Andrew von Eschenbach, Acting FDA Commissioner. “These results make clear there are Internet sites that claim to be "Canadian" that, in fact, are peddling drugs of dubious origin, safety, and efficacy. We believe that these ‘bait and switch’ tactics-offering patients one thing and then giving them something else- are misleading to patients and potentially harmful to the public health.”*
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