All 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements on MedWatch
This is the time of year when itís dark by 5:00 PM, temperatures drop, and for some reason, we start eating more. Weather itís because we are gathering for more holiday parties, or just because we know we can cover up with a heavy sweatshirt, it's important to realize that there are still foods we can eat that will keep us fit all winter long.*
FDA News Digest November 28, 2005
FDA Answers Questions a bout Protective Equipment for Flu Outbreaks
Web Pages Give Background on Recently Approved Medical Devices
Recalls & Safety Alerts
Upcoming Public Meetings
QUESTION OF THE WEEK - How do I report a bad reaction or other problem related to drugs, biological products, medical devices, food, or cosmetics?
FDA created the MedWatch program to monitor adverse effects and problems with medical products the agency regulates (human drugs and medical devices, for example). MedWatch is a voluntary reporting system available to consumers or health professionals by going to http://www.fda.gov/medwatch/index.html. Click on "How to Report", then "Reporting by Consumers" or "Reporting by Health Professionals." You also can call the FDA Division of Drug Information at 301-827-4573 and request that a MedWatch Voluntary Reporting Form be sent to you.
To report adverse reactions or other problems with food (except meat and poultry), contact the FDA district office consumer complaint coordinator for your geographic area. A list is at http://www.fda.gov/opacom/backgrounders/complain.html. For problems with meat and poultry, which the U.S. Department of Agriculture regulates, call 1-800-535-4555.
For problems with vaccines, FDA and the Centers for Disease Control and Prevention maintain the Vaccine Adverse Event Reporting System. To report a vaccine problem online, go to https://secure.vaers.org/VaersDataEntryintro.htm.
For more on reporting problem products to FDA, go to http://www.fda.gov/opacom/backgrounders/problem.html.*
Safety-related drug labeling changes for September 2005 have been posted on the MedWatch website. The September 2005 posting includes 38 drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections.
The Summary page -- http://www.fda.gov/medwatch/SAFETY/2005/sep05_quickview.htm -- provides drug names and a listing of the sections changed.
The Detailed view -- http://www.fda.gov/medwatch/SAFETY/2005/sep05.htm -- includes sections/subsections changed and a description of new or modified safety information in the Contraindications, Boxed Warning, or Warnings sections. The full labeling may be accessed by clicking on the drug name in the detailed view.*
FDA notified consumers, caregivers, and healthcare professionals that MBI Distributing, Inc. (MBI), also known as Molecular Biologics, an over-the-counter [OTC] drug manufacturer of eye drops and other products will cease manufacturing and distributing drugs until it corrects manufacturing deficiencies and other violations. MBI's product line includes eye drops sold under the brand names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C, as well as several OTC pain relieving drugs. These products are sold by retailers nationwide.
FDA determined that the firm lacked manufacturing controls to ensure that its eye drops were sterile. FDA has also determined that two of the firm's eye drop brands, Visitein and Clarity Vision for Life, are unapproved drugs. In addition, three of the firm's OTC pain relieving drugs, Biogesic, Bio-Ice, and Bio-Heat, do not provide adequate warnings for their safe use. FDA recommends that consumers, health care providers, and caregivers dispose of the Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C brands of eye drops and the Biogesic, Bio-Ice, and Bio-Heat pain relieving drugs.
Read the complete MedWatch 2005 Safety summary, including links to the FDA Press Release, at:
How to compile your family medical history - Your family medical history provides insight into the diseases and conditions that are common to your family. Use this history to give you clues about your risk of disease.
Family gatherings are an ideal time to catch up on family news and information. They also provide a good opportunity to learn about your family's health history. Mapping your family medical history can help you identify some health risks you may face in the years ahead and help you take measures to avoid or plan for them.*
Herbal supplements: What to know before you buy - If you're thinking of trying herbal supplements, understand that they aren't right for everyone. Here's what you should know before you set out to make that purchase.
Herbal supplements may be popular, but are they for you? That depends on the herb, your current health and your medical history. Herbal supplements have active ingredients that can affect how your body functions, just as over-the-counter and prescription drugs do. Herbal supplements may be particularly risky for certain individuals, and their labels are often vague, confusing and of little help when it comes to making a selection. If you're considering herbal supplements, educate yourself about any products you intend to use before purchasing them, and talk to your doctor about any herbal supplements you're considering taking.*
Chest Pain - It's the middle of the night or maybe the beginning of a busy workday when you suddenly feel pain in your chest. You try to ignore it at first, but your chest pain has you scared and worried. Could you be having a heart attack? Should you go to the emergency room?
Chest pain is one of the most common reasons people call for emergency medical help. Every year emergency room doctors evaluate and treat millions of people for chest pain.
Fortunately, chest pain doesn't always signal a heart attack. Often chest pain is unrelated to any heart problem. But even if the chest pain you experience has nothing to do with your cardiovascular system, the problem may still be important ó and worth the time spent in an emergency room to have your chest pain evaluated.*
Handout on Health: Back Pain - This booklet is for people who have back pain, as well as family members, friends, and others who want to find out more about it. The booklet describes causes, diagnosis, and treatments, and research efforts to learn more about it, many of which are supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other components of the Department of Health and Human Servicesí National Institutes of Health (NIH). If you have further questions after reading this booklet, you may wish to discuss them with your doctor.*
My Family Health Portrait allows you to create a personalized family health history report from any computer with an Internet connection and an up-to-date Web browser. Information you provide creates a drawing of your family tree and a chart of your family health history. Both the chart and the drawing can be printed and shared with your family members or your healthcare professional. Used in consultation with your healthcare professional, your family health history can help you review your family's health history and develop disease prevention strategies that are right for you.*
The Counterfeit Drug Problem - Mr. Chairman and Members of the Subcommittee, I am Randall W. Lutter, Ph.D., Acting Associate Commissioner for Policy and Planning, at the U.S. Food and Drug Administration (FDA or the Agency).
Thank you for the opportunity to testify about FDAís efforts regarding counterfeit prescription drugs. ††Let me emphasize that the overall quality of drug products that consumers purchase from United States pharmacies remains high. ††The American public can be confident that these medications are safe and effective. ††FDA cannot, however, offer the same assurance to the public about the safety and quality of drugs purchased from sources that are outside the U.S. regulatory system. ††My testimony today will focus on FDAís efforts to further secure the safety of our nationís drug supply.*
What is Ayurvedic Medicine? - Ayurvedic medicine (also called Ayurveda) is one of the world's oldest medical systems. It originated in India and has evolved there over thousands of years. In the United States, Ayurveda is considered complementary and alternative medicine (CAM)--more specifically, a CAM whole medical system. Many therapies used in Ayurveda are also used on their own as CAM--for example, herbs, massage, and yoga. This Backgrounder will introduce you to Ayurveda's major ideas and practices and provide sources for more information on these or other CAM therapies.*
Medicare Part D - An APA expert answers common questions about Medicare Part D, Medicare's new prescription drug program - This month's expert: Carol L. Alter, M.D., vice chair of APAís Committee on Managed Care, executive director, the TEN Project, and Associate Professor, Georgetown University.*
Patient Rights and Patient Safety.
FDA News Digest for October 24, 2005
There have been recent alerts that using ADD and anti-depressants together may cause increased suicidal thoughts in both adults and children.
Since I've been taking anti-depressants and was recently diagnosed ADD, I've been looking into this further for my own benefit. And, considering I'm a Marf and most ADD meds are amphetamines, I also have to be careful about any ADD meds suggested.
I decided I didn't want to take both ADD and anti-depressants at the same time and weaned myself off the Wellbutrin I've been taking. Cymbalta was one of the meds suggested for ADD and since it's also used for pain (Albeit diabetes related pain) and sleep disorders, I decided this would be the best bet to try first. I'm glad I made this decision as it's helped me greatly compared to the anti-depressants...for specific reasons obviously. :-)
Anyway, I've found some related articles about these two types of meds, ADD, depression, and more, and thought I'd gather them here together, hopefully to help others dealing with these same issues.
Antidepressant Use in Children, Adolescents, and Adults - Food and Drug Administration (FDA) asks manufacturers of all antidepressant drugs to include in their labeling a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and additional information about the results of pediatric studies.*
ParentsMedGuide.org - As the parent or guardian of a child or teen-ager with clinical depression, a physician seeking more information, or as a patient yourself, you may be aware of the recent decision by the Food and Drug Administration (FDA) to attach a cautionary label, or "black box warning," to all antidepressant medications used to treat depression and other disorders in children and adolescents.
The American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry have prepared these Guides to help patients, families, and physicians make informed decisions about obtaining and administering the most appropriate care for a child with depression.*
Antidepressant Medications for Children and Adolescents: Information for Parents and Caregivers
Attention Deficit Disorder with Hyperactivity
Child Mental Health Topics
Depression Topics #1
Depression Topics #2
Directory of Advocacy and Support Groups for Youth with Emotional, Developmental and Behavioral Disorders
Mental Health Medications
Mental Health Medications for Children
Mental Health Topics
Teen Mental Health Topics
Saving Money On Prescription Drugs - By Michelle Meadows
Aortic valve regurgitation - Aortic valve regurgitation ó or aortic regurgitation ó is a condition that occurs when your heart's aortic valve doesn't close tightly. Aortic valve regurgitation allows blood that was just pumped out of your heart to leak back into it.
The leakage of blood may prevent your heart from efficiently pumping blood out to the rest of your body. If your heart isn't working efficiently, you may feel fatigued and short of breath.
Aortic valve regurgitation can develop suddenly or over decades. It has a variety of causes, such as rheumatic fever. Once aortic valve regurgitation becomes severe, surgery is usually required to repair or replace the aortic valve.
Aortic valve regurgitation is also called aortic insufficiency or aortic incompetence.*
Healthy Women Today's October Recipes
Itís National Apple Month and the peak of the U.S. apple harvest. Apples and apple foods, such as 100 percent apple juice and applesauce, are healthy treats that anyone can feel good about eating. They are an excellent source of fiber and are fat-free.
These recipes from The U.S. Apple Association, www.usapple.org, can help you reach your goal of 5 to 9 servings a day of fruits and vegetables.*
Roasted Pork Loin with Quinces and Baby Apples - http://www.usapple.org/consumers/recipes/pork_quinces.shtml
Apple Chicken Stir Fry - http://www.usapple.org/consumers/recipes/stirfry.shtml
Creamy Polenta with Apple and Quince Chutney - http://www.usapple.org/consumers/recipes/polenta.shtml
Carmel Apples and Pears - http://www.usapple.org/consumers/recipes/caramelapples.shtml
Maple Cider Punch - http://www.usapple.org/consumers/recipes/maplecider.shtml
FDA News Digest for October 3, 2005
IN THIS WEEK'S ISSUE:
FDA Warns of Suicidal Thoughts in Users of ADHD Drug Strattera
Rule Finalized for Requiring Registration of Food Facilities
2005 Food Code Updates Food Safety Guidelines for Industry
FDA Consumer Magazine Available Online
Recalls, Withdrawals and Alerts in the Last 60 Days
Question of the Week: What is Liposuction?
HOW'S YOUR KNOWLEDGE of health topics such as generic drugs, mammograms, epilepsy, or pediatric drugs? Find out by taking our online quiz at http://www.fda.gov/fdac/quiz/onlinequiz25_js.html.*
Choosing a Doctor or Health Care Service
Hurricane Katrina: Mental Health Recommendations for Students and Colleges
Chronic Pain: Exercise Can Bring Relief
Safety-Related Drug Labeling Changes for July 2005
September Recipes - Back to School
Latest FDA Consumer Magazine Available Online
The May-June 2005 issue of FDA Consumer has articles on the following topics:
Hearing loss - How to help overcome this age-related condition.
Human tissue transplants - New FDA rules help prevent disease transmission.
Whooping cough - Children aren't the only ones who need to be protected from this infectious disease.
Healthier eating - These tips can help you make smarter food choices.
Dry eye - How to get relief from this disorder.
Laser pointers - FDA is concerned about the misuse of these devices.
NSAIDs - FDA is taking steps to guide the millions who rely on these pain-relieving drugs.
FDA reforms - HHS Secretary Leavitt envisions a new kind of agency openness and oversight.
The issue is online at http://www.fda.gov/fdac/305_toc.html.
Subscribe to print version of FDA Consumer: http://www.fda.gov/fdac/orderform/fdap.html.*
MedWatch - LifeScan, Inc, initiated a worldwide notification to all users of its OneTouch Ultra, InDuo and OneTouch FastTake Meters. LifeScan found that it was possible for consumers, in the course of setting their meter's date and time, to accidentally change the unit of measure and thereby misinterpret their blood glucose results. The notification program includes letters to registered users and health care professionals, and also special instructions inserted in each package of test strips. The products are distributed worldwide primarily through retail pharmacy and mail order channels.*
MedWatch - FDA notified healthcare professionals that serious injury or death can occur when patients with implanted neurological stimulators undergo MRI procedures. The FDA received several reports of serious injury, including coma and permanent neurological impairment. The mechanism for these adverse events is likely to involve heating of the electrodes at the end of the leadwires, resulting in injury to the surrounding tissue. The public health notification also offered recommendations for preventive actions.*
with questions or comments about this web site.