Canadians warned about Ketek one year before Americans

Health Canada, the Canadian equivalent to the Food and Drug Administration (FDA), warned doctors and patients about the possibly deadly side effects of Ketek over one year before the FDA did the same for its population. On February 7, 2006, Health Canada sent out a press release about “a possible link between use of the antibiotic Ketek and potentially serious liver problems.” This link was identified in a research paper published in the Annals of Internal Medicine that month. The agency recommended that anyone with liver problems should stop taking Ketek and that those displaying signs of jaundice should seek immediate medical attention.

Ketek, the “wonder drug” that was initially approved for treatment of sinusitis, bronchitis, and pneumonia, showed early signs of causing liver damage even before it was introduced on the market. In fact, it was as early as 2000 that problems started cropping up in Sanfori-Aventis’s own research of their drug. Subsequent trials that did not even meet FDA’s current standards were found to be falsified. One doctor was sentenced to 57 months in jail for signing up 400 patients including her family members, staff members, and patients who had no idea they had been “enrolled.”

But despite these problems, the FDA went ahead and approved Ketek for sale in the U.S. in 2004. Some industry experts see this move as a clear sign that the agency assigned to protecting the American consumer is instead helping drug companies get their drugs to market faster. There are several reasons for this, including the fact that drug companies pay about $300 million per year in user fees, and that many FDA officials eventually go on to hold positions at the very companies they are supposed to be regulating.

In any case, when more conclusive proof of possible liver damage started to emerge including the Annals of Internal Medicine article, the FDA still refused to let the American public know about the dangers. Records show that even scientists within the FDA indicated that there could be a major problem, but ultimately it wasn’t until the eve of a Congressional inquiry into the FDA’s approval of Ketek that the agency announced the possible dangers including a new Black Box warning for the drug.

Are doctors and consumers expected to follow health advisories from foreign countries in order to find out what drugs are safe and what are not? Is the regulatory system so broken that we cannot trust our own FDA to give us timely warnings about Ketek or any other medication?

Regardless of the state of the FDA, it is ultimately the drug companies themselves that are responsible for the safety of their products. If you have experienced major side effects while taking Ketek including liver damage or liver failure, contact Jim S. Adler & Associates. We may be able to help you get the financial reward you need to cover your medical bills and lost wages, as well as compensation for your pain and suffering. Call a Jim S. Adler & Associates personal injury lawyer directly right now for more information. Or fill out the form on this page with the details of your Ketek injury to start your free case review.