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Drug warnings & news
FDA Warns Consumers About Tainted Weight Loss Pills
Agency seeks recall of products that pose serious health risks
The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.
The tainted weight loss products are:
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Fatloss Slimming |
2 Day Diet |
3x Slimming Power |
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Japan Lingzhi 24 Hours Diet |
5x Imelda Perfect Slimming |
3 Day Diet |
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7 Day Herbal Slim |
8 Factor Diet |
7 Diet Day/Night Formula |
|
999 Fitness Essence |
Extrim Plus |
GMP |
|
Imelda Perfect Slim |
Lida DaiDaihua |
Miaozi Slim Capsules |
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Perfect Slim |
Perfect Slim 5x |
Phyto Shape |
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ProSlim Plus |
Royal Slimming Formula |
Slim 3 in 1 |
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Slim Express 360 |
Slimtech |
Somotrim |
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Superslim |
TripleSlim |
Zhen de Shou |
|
Venom Hyperdrive 3.0 |
|
|
An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk.
These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.
The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately.
“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”
FDA adds suicide warning to epilepsy drugs
The FDA announced it was adding new warnings to the labels of antiepileptic drugs regarding a heightened risk of suicide among users. This action stops short of the strongest warning a drug can have which is the "black box" warning. Patients taking these antiepileptic drugs should be monitored for any signs of the emergence of or worsening of depression, suicidal thoughts, behavior or unusual mood changes. Again the warning issued includes a heightened risk to users of suicidal thoughts and behaviors.
FDA investigating Vytorin cancer link
Based on recently released studies showing Vytorin increasing the risk of cancer, the FDA announced that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer.
FDA Seeks stronger warnings for Byetta
The U.S. Food and Drug administration is seeking stronger warnings for people taking the diabetes drug Byetta due to the risk of pancreatitis after the deaths of two patients. The FDA announced it had received six reports of hemorrhagic or necrotizing pancreatitis requiring hospitalization. In October, the FDA said it had reviewed 30 reports of pancreatitis in patients being treated with Byetta.
Vytorin news: clinical trials of Vytorin did not help people avoid heart related problems but did show an increase risk of cancer. A clinical study known as "Seas" showed an increase risk of cancer for those patients taken Vytorin. These results heighten the concern over the drugs safety and effectiveness.
The FDA said today that Bayer Pharmaceuticals Corp. has agreed to an agency request to suspend marketing of the company's Trasylol blood-clotting drug because of an increased risk of death.
Avandia Warning
FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. The new information refers to a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, that showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options. Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.
Cefepime warning
FDA issued an early communication about the ongoing review of new safety data and the request for additional data to further evaluate the risk of death in patients treated with cefepime. An article in the May 2007 issue of The Lancet Infectious Diseases (Efficacy and safety of cefepime: a systematic review and meta-analysis) raised the question about increased mortality with the use of cefepime, a broad spectrum B-lactam antibiotic currently approved for the treatment of a variety of infections due to susceptible strains of microorganisms. The article describes a higher all-cause mortality in patients treated with cefepime compared to other B-lactam antibiotics. Until FDA's evaluation is completed, healthcare professionals who are considering the use of cefepime should be aware of the risks and benefits described in the prescribing information and the new information from this meta-analysis.
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