Vytorin is a combination of simvastatin (Zocor) and ezetimibe (Zetia). Vytorin reduces the amount of cholesterol (a type of fat) absorbed by the body and block the production of cholesterol in the body.

In August 2008, the U.S. Food and Drug Administration (FDA) issued an Early Communication describing a possible association between the use of Vytorin and an increased risk of cancer and cancer-related death compared to placebo. The Early Communication was based on preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. FDA has now completed its review of the data from the SEAS trial as well as a review of recent data from two large-scale ongoing cardiovascular trials with Vytorin. Based on the currently available information, FDA believes it is unlikely that Vytorin increases the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out.

FDA is not advising healthcare professionals or consumers to stop using these medications, but to continue to evaluate the clinical benefits and potential risks of Vytorin or Zetia compared to other FDA-approved cholesterol lowering medications. Consumers should talk to their healthcare professional if they have any questions about Vytorin, Zetia, Zocor or the SEAS trial.

For more information about the FDA’s report, click here.

Labels: cancer, FDA, health care providers, Vytorin

The Food and Drug Administration (FDA) has released several alerts over the last six months about the illegal and possible dangerous addition of active prescription drug ingredients to otherwise ineffective weight-loss supplements. The FDA has identified 72 weight loss products that illegally contain at least one active prescription drug. The prescription drugs being added to these weight loss products include:

• Sibutramine (MERIDA) - A controlled substance and an appetite suppressant available by prescription only.
• Fenproporex- A stimulant drug that is not approved for marketing in the United States.
• Fluoxetine (PROZAC, SERAFEM) - An antidepressant available by prescription only
• Bumetanide (BUMEX) - A diuretic available by prescription only
• Furosemide (LASIX) - A potent diuretic available by prescription only.
• Rimonabant (ZIMULTI)- An appetite suppressant not approved for marketing in the United States.
• Cetillstat- An experimental obesity drug not approved for marketing in the United States.
• Phenytoin (DILANTIN) An anti-seizure drug available by prescription only.
• Phenolphthalein- A suspected cancer causing agent and a solution used in chemical experiments. This drug is not approved for marketing in the United States.

The FDA warned that 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 maximum recommended dosages.

If you have any products containing these ingredients, you should stop taking them immediately, and consult your health care providers. In addition, consumers should seek guidance from health care providers prior to purchasing any weight loss products.

Consumers and health care providers should report any side effects of weight loss products to the FDA’s MedWatch Adverse Event Reporting Program. This can be done at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Labels: drugs, FDA, health care providers, weight loss pills