Problems Associated with Ketek Extend Beyond Liver Problems

July 2, 2007, 9:00AM. By Heidi Turner

Washington, DCThe side effect most people think of when they hear the name Ketek is liver failure. However, at least one person has had a different, life-threatening reaction to Ketek; now patients are investigating the possibility of filing lawsuits against the manufacturer Sanofi-Aventis for serious side effects like toxic epidermal necrolysis (TEN).

The patient, a young woman in Canada, spent four weeks in a burn unit last year after taking Ketek for a sinus infection. The woman allegedly had a serious reaction to the drug, which resulted in burn-like blisters all over her body and peeled off her skin. The condition is known as toxic epidermal necrolysis (TEN). TEN often leaves patients with permanent scars and other serious health problems.

Although the condition is extremely rare, Sanofi-Aventis was in discussions with Health Canada about whether or not to strengthen warnings about the risk of "skin events" in patients taking the antibiotic. The woman's skin peeled over all of her body, including her mouth, and she lost her eyelashes. She was treated with an IV to prevent infections and lotions to keep her skin lubricated.

In Canada, Ketek has been linked to one death and 105 adverse reactions. A 55-year-old woman died of a heart attack after taking Ketek for 10 days. In the U.S., Ketek has been linked to 53 cases of liver damage and four deaths. The FDA reports that Ketek was involved in nine deaths worldwide.

Late last year the Food and Drug Administration (FDA) voted to keep Ketek on the market to treat mild to moderate pneumonia. However, the FDA panel said that Ketek should only be a secondary alternative to other medicines. The panel also recommended that Ketek should have a black box warning about its serious side effects.

Critics of the FDA alleged that agency officials intimidated subordinates into approving Ketek and had too close a relationship with pharmaceutical companies. Dr. David Graham, an FDA safety official, further claimed that FDA officials lied when they said the FDA does not require further funding from Congress for drug safety monitoring.

With so many serious side effects it is still not clear why Ketek was ever approved in the first place. According to an article in the New York Times, of the 12 cases of liver failure associated with Ketek, only two patients were taking the drug to treat a serious illness. That means that 10 people risked their lives to treat a non-life threatening problem. The risks seem far higher than the benefits. While four deaths in the U.S. may not seem like a high number given the total number of people who took the drug, when the reason for taking the drug is to treat a minor sinus infection, any death at all is absolutely unreasonable.

What is even more confounding is that FDA officials allegedly concealed knowledge of falsified safety trial results from the FDA panel to approve a drug that is not of serious importance to the general population. Ketek does not save lives. There are other drugs that can treat sinus infections and they do not come with a risk of liver failure.

In fact, Dr. Graham, as quoted in the New York Times, wrote in a message from June 16, 2006, "We don't really know if the drug works; no one is claiming it works better than other, safer drugs; and we're flying blind as far as safety goes, except for our own A.D.R. data that suggest telithroymycin (Ketek) is uniquely more toxic than most other drugs." So why was it necessary to approve Ketek, ignoring all signs of liver problems in patients and ignoring the warnings of other FDA officials?

There may never be a satisfactory answer to that question. Meanwhile, patients are left to recover from liver disorders and other serious adverse reactions to the antibiotic.