FDA Warns About Misleading Internet Ads for Tysabri and Plavix
Internet ads for the multiple sclerosis drug Tysabri and blood thinner Plavix which pop up as links on search engines do not include required safety information, the Food and Drug Administration warns.
The FDA has sent warning letters to the two drugs’ makers, Biogen Idec Inc. and Sanofi-Aventis, ordering them to fix the problems with the advertisements and respond in writing by April 9, 2009. The companies must tell the FDA if and how they plan to comply with the order.
The ads in question pop up on Google and other search engines. The ad for Tysabri “(makes) representations and/or suggestions about the efficacy of Tysabri but fail to communicate any risk information associated with the use of this product,” according to the FDA.
The misleading ads “suggest that Tysabri is safer than it is known to be,” the FDA said.
Tysabri May Cause Deadly Brain Infection
Tysabri, which in addition to multiple sclerosis also is approved for the treatment of Crohn’s disease, has been linked to a potentially deadly brain infection, progressive multifocal leukoencephalopathy (PML). The drug was approved by the FDA in 2004, but was quickly recalled after reports of patients developing PML. It was later allowed back on the market after changes to the labeling were ordered to call attention to the increased risks of using the drug.
Tysabri also has been linked to cases of liver toxicity and malignant melanoma detected shortly after the drug was administered.
Plavix Ad Also Questioned
The FDA also warned the makers of Plavix for an Internet ad, which fails to spell out the risks of the drug as required. The ads for the drug omit the most serious and common risks associated with the drug, which “misleadingly suggest that Plavix is safer than has been demonstrated,” the FDA said in its letter to Sanofi.
Plavix is an anti-clotting drug used to prevent heart attacks and strokes in patients who have undergone artery-clearing procedures. However, the drug has been shown to increase the risk of serious bleeding. Plavix was approved in 1997 and is one of the top-selling drugs in the United States. Studies have found that people taking the drug to prevent blood clots are four-to-five times more likely to suffer from life-threatening bleeding.
The FDA also urged Sanofit to review its promotional materials for other drugs it sells and either stop using or rewrite the materials if the company finds similar factual omissions like those found in regards to Plavix.
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