The makers of Tysabri and Plavix have been warned about internet ads for the drugs. According to the Food & Drug Administration (FDA), the Tysabri and Plavix ads fail to provide required safety information.
According to a report on Reuters.com, the makers of the drugs have been directed to rectify the problems with the ads. They must submit a written response by April 9 stating whether they intend to comply.
The Tysabri and Plavix ads in question appear as sponsored links on internet search engines, like Google. In a March 26 letter to Biogen Idec, the maker of Tysabri, the FDA says sponsored links for Tysabri “make representations and/or suggestions about the efficacy of Tysabri, but fail to communicate any risk information associated with the use of this product.”
Tysabri was taken off the market by the FDA in 2005 after three patients in clinical trials developed progressive multifocal leukoencephalopathy (PML), an often deadly brain disease. But the drug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn’s disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.
A letter to Sanofi-Aventis voiced similar criticism over sponsored links for Plavix, an anti-clot drug. “By omitting the most serious and frequently occurring risks associated with Plavix, the sponsored links misleadingly suggest that Plavix is safer than has been demonstrated,” the letter said. Plavix is known to increase the risk of serious bleeding.
According to The Wall Street Journal, a total of 14 drug makers received warning letters about sponsored links for 48 drugs. GlaxoSmithKline was warned about sponsored links for several of its drugs, including the diabetes drugs Avandia, Avandamet and Avandaryl, the blood pressure medicine Coreg, Avodart for enlarged prostate and the breast cancer drug Tykerb. Pfizer received a letter criticizing its sponsored links for the anti-smoking drug Chantix, and its arthritis drug Celebrex.
The other companies that received letters are: Johnson & Johnson, Forest Laboratories Inc., Cephalon Inc., Bayer AG, Novartis AG, Merck & Co., Eli Lilly & Co., Roche Holding AG, Genentech Inc., and Boehringer Ingelheim Pharmaceuticals Inc., the Journal said.
Of the drugs cited by the warning letters, the Journal said 19 carry black box warnings – the FDA’s strongest safety notice – about potential side effects.
A spokesperson for the FDA told The Wall Street Journal that the agency hasn’t contacted any of the search engines where the ads have appeared because the FDA doesn’t contact third parties that carry ads, even if violate agency rules.
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April 6th, 2009 at 3:43 pm
Your article incorrectly states:
“(PML), a often deadly brain disease”…, PML is a RARE viral infection pursuant to the expert authors of the New England Journal of Medicine…, see:
http://tinyurl.com/2mhn82
Please issue a corrected article regarding the above.
Respectfully submitted,
Lauren Roberts – MS patient for 33 plus years, and current Tysabri patient for more than two years