FDA Launches Drug Safety Newsletter - Spread the word to your health care providers: The Food and Drug Administration has launched the first issue of the Drug Safety Newsletter, a quarterly publication designed to raise awareness about reported adverse events and stimulate more reporting. An adverse event report is a communication to FDA of an undesirable sign or symptom associated with a drug.*
FDA Announces Initiative to Bolster Generic Drug Program - Effort will streamline generic drug approval process; provide more options for consumers, health professionals - The U.S. Food and Drug Administration today outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process.*
A Silver Bullet for Blake - Unwilling to sit by while his youngest patients succumbed to Marfan syndrome, cardiologist Hal Dietz turned to bench science. His nearly two-decade quest in the lab has paid off big, bringing new hope to sufferers of Marfan—and a host of other devastating conditions. - by Elaine Freeman
“It was truly a jaw-dropping moment,” Dietz told Science magazine’s reporter, throwing his usual reserve to the winds. “It was beyond anything I could have anticipated or hoped.” Now he had proof a drug already approved by the FDA might hold the answer to the “rotten frame” ravaging the bodies of Marfan patients.
In this case, Dietz’s unique blend of inspiration and dogged persistence led to a growth factor dubbed TGF-beta as the mysterious pathway.
Transforming growth factor-beta is a family of signaling molecules that tell cells when to divide, where to migrate, what proteins to make—and when to die. Usually this occurs in an orderly, appropriate fashion. But triggered by a genetic defect, TGF-ß may give totally different directions to different cells—all resulting in inappropriate behavior.
Dietz became suspicious when he realized that the structure of a TGF-ß regulatory protein resembled fibrillin-1, the Marfan gene—and that TGF-ß regulatory proteins bind to fib-1. If a mutation in the fib-1 gene causes a fibrillin-1 deficiency, he hypothesized, it also might unleash too much TGF-ß activity, triggering a whole cascade of inappropriate behavior.
In the lungs of patients with Marfan, TGF-ß might tell cells to die inappropriately, preventing division into alveoli, the small air-filled sacs necessary for normal breathing.
In the aorta, it might tell cells to make enzymes to break down tissues.
In muscles, it might suppress the ability of stem cells to regenerate muscle. In bones, it might tell cells to divide inappropriately. Too many cells, and abnormal tissue might form—such as the overgrowth of bone in the long fingers.
Block the TGF-ß pathway and cell behavior should return to normal.
Beyond Marfan: Losartan’s Promise - Discovering that TGF-ß is the critical pathway in Marfan could lead to breakthroughs in the treatment of other conditions. The picture that’s emerging, says Hal Dietz, “is that many forms of vascular disease,” including aortic aneurysms, “are caused by too much TGF-ß signaling.”
Dietz and his protégés are particularly excited about losartan’s potential to treat muscular dystrophy (MD). In Duchenne muscular dystrophy, the most common form, as in Marfan syndrome, muscle weakness is due to the inability of stem cells in the muscle to repair damaged muscle cells. TGF-ß turns out to be the culprit in blocking muscle cells’ normal regenerative ability. The Dietz team proved this in a mouse model, then used losartan to block the TGF-ß signal, clearly correcting the malfunction. They published their results in January 2007 in Nature Medicine.
While losartan doesn’t prevent muscle destruction, it facilitates regeneration of new muscle cells. For MD patients, this could slow progression of the disease and improve muscle performance and breathing—without pernicious steroids. To test this possibility, Ronald Cohn—who now has funding to establish his own lab—is planning a clinical trial with the Muscular Dystrophy Association.
Dietz’s collaborators also are pursuing other leads for losartan. One postdoc is looking at a geriatric population: What’s the difference in body mass of individuals who took losartan for hypertension vs. those prescribed a beta blocker? Another is looking at rare genetic models of premature aging. Still another is focusing on muscle weakness in patients on chemotherapy. Losartan might have a role there, too. Elaine Freeman*
What an exciting article about Hal Dietz's research on TGF-ß and Losartan! Thanks to Dr. Loren Cobb for sharing this article with me.
Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk - Companies Will Include Boxed Warning on Drug Label - The U.S. Food and Drug Administration today announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a "boxed" warning—FDA's strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.
After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. FDA had asked the drug's manufacturers, GlaxoSmithKline and Takeda, to address these concerns.*
Serotonin syndrome - Serotonin syndrome is a condition characterized by dangerously high levels of serotonin — a chemical produced by nerve cells — in your body.
Serotonin syndrome can occur when you take certain combinations of prescription medications that affect serotonin levels in your body. For example, serotonin syndrome can occur if you take selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) for depression along with triptan medications to treat migraine. Serotonin syndrome can also occur if you take SSRIs with other drugs or supplements that affect serotonin levels, such as St. John's wort.
Signs and symptoms of serotonin syndrome range from restlessness and rapid heartbeat to muscle rigidity and seizures. These go away quickly with treatment, which may include discontinuing use of the medications causing the symptoms along with taking other drugs such as muscle relaxants and serotonin-production blocking agents. If not treated quickly, serotonin syndrome can become life-threatening.*
FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet - Practice Puts Consumers at Risk and May Be More Expensive than Domestic Purchasing - The U.S. Food and Drug Administration continues to warn the American public about the dangers of buying medications over the Internet.
New data collected by the FDA show that consumers who are trying to save money on prescription drugs don’t need to take chances by buying prescription drugs from foreign Internet sites, because low-cost generic versions are available in the United States. This finding also may be an indication that some consumers are likely buying foreign drugs this way to avoid getting a prescription from their doctor or health care professional, since many Web sites do not require a prescription.*
The Possible Dangers of Buying Medicine Online - The Food and Drug Administration cannot warn people enough about the possible dangers of buying medications online. Some Web sites sell medicine, such as prescription and over-the-counter drugs, that may not be safe to use and could put people's health at risk. The current system of federal and state safeguards for protecting consumers from using inappropriate or unsafe drugs has generally served the country well. But FDA says that the best way consumers can protect themselves is to become educated about safe online shopping.*
Mo - From a recent National Marfan Foundation e-mail "...a Long Island based independent filmmaker has been working on a feature film about his younger brother's experience with Marfan syndrome. It stars Erik Per Sullivan (Dewey from "Malcolm in the Middle"), and Margo Martindale (a well known character actress from such movies as "Million Dollar Baby," "Dead Man Walking" and many more).*"
The web site is "Flash" based and I can't quote anything from them, but you should at least check out the trailer for the movie. However, turn your speakers down first since music does start playing as soon as the site loads.
FDA Requests Label Change for All Sleep Disorder Drug Products -
The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."
The medications that are the focus of the revised labeling include the following 13 products:
Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Restoril (Tyco Healthcare)
Sonata (King Pharmaceuticals)
For more information on the sedative hypnotic products and sleep disorders, visit Sleep Disorder (Sedative-Hypnotic) Drug Information; Sleep Disorders - Get The Facts and What Is Insomnia?.*
Prescription Drug Abuse - Abuse of prescription drugs to get high has become increasingly prevalent among teens and young adults. Past year abuse of prescription pain killers abuse now ranks second—only behind marijuana—as the Nation’s most prevalent illegal drug problem.*
Healthy Woman Today Newsletter for February - Have you ever had a bad feeling about something, but your logical side told you that everything was OK? Some research has shown that a lot of women might feel badly physically, but they don't do anything about it because their symptoms don't seem out of the ordinary.
For example, women who are having a heart attack might not have chest pain, commonly considered a hallmark sign. If they do, they might call it an achy, tight, or "heavy" feeling instead of pain. The pain might even be in the back between the shoulder blades, instead of the chest. Another common sign for women may be feeling really tired, even after getting enough sleep. Learn more about other signs of heart disease in women in our section on heart health.
Being aware of these signs in women is a good first step. And, you can take action to keep your heart healthy. During February, celebrate more than love by taking heart healthy steps in honor of American Heart Month, National Wear Red Day, Congenital Heart Defects Awareness Week, and National Women's Heart Day! Find out if heart disease runs in your family, visit your doctor to find out if you are at risk, don't smoke or quit smoking, get your blood pressure and cholesterol checked, stay active or start a fitness routine, and eat right and keep a healthy weight.
Most importantly, if you feel like something isn't right, learn to trust your heart. More than likely it's going to lead you in the right direction.
Valerie Scardino, M.P.A.
Communications Director, Office on Women's Health, HHS*
February's Featured Health Topic - Heart Health - February is all about the heart—and we're not just talking about Valentine's Day! As heart disease is the nation's number one killer, we recognize the importance of keeping heart healthy during American Heart Month along with National Wear Red Day 2007 (February 2nd), Congenital Heart Defects Awareness Week (February 7th -14th), and National Women's Heart Day (February 16th). Womenshealth.gov believes it's important to have a wide variety of resources for you and your family. Here are some of the best resources on our web site:
February Recipes - The For Your Heart section of womenshealth.gov has some great recipes that are heart-healthy and perfect for a Valentine's Day dinner!
Other News - Over 92,000 people are waiting for the gift of life - Each day, about 74 people receive organ transplants. However, 19 people die each day waiting for transplants that can't take place because there is a shortage of donated organs. Organdonor.gov would like you to consider becoming an organ donor on February 14th, Organ Donor Day.*
Healthy Women Today - January Recipes:
An essential part of becoming a healthier you is making healthy choices. These recipes from the HHS book, A Healthier You, will help you jump start the New Year right!
Vegetables With a Touch of Lemon
Baked Salmon Dijon
Mousse à la Banana*
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