Use of the Antibiotic Ketek® Should Be Limited, FDA Panel Says
WASHINGTON, DC — December 22, 2006 — Two government advisory panels have recommended strictly limiting the use of the antibiotic Ketek®, which has been linked to liver failures and deaths. They also suggest adding a “black–box” warning to the drug’s label. This warning is the highest alert about a drug’s side effects, short of pulling the drug off the market.
Doctors prescribe Ketek® to treat sinusitis, bronchitis and a bacterial form of pneumonia. After two days of meetings, the drug safety committee and the anti–infective drug panel of the Food and Drug Administration (FDA) urged the agency to restrict Ketek® use to the treatment of pneumonia. Unlike bronchitis and sinusitis, pneumonia can be a fatal disease. Even for pneumonia patients, however, panel members agreed that an alternative medication should be tried before prescribing Ketek®.
“Based upon the data available to me, I believe this drug is far more dangerous than other drugs that fight the same infections,” said Dr. David Ross, a former FDA employee who originally reviewed Ketek®’s safety prior to its approval (CBS News, December 13, 2006). Dr. Ross explained at the hearings that he had been “pressured to soften my review” (New York Times, December 16, 2006).
The two recent FDA panels evaluated post–marketing reports as well as pre–marketing data before concluding that Ketek® use should be restricted. The FDA does not have to follow the advice of its panels, although it usually does so.
Ketek®’s Questionable Past
Since Ketek® was approved in April, 2004, the FDA has received at least 110 reports of injuries caused by the drug, including 23 cases if liver damage, 14 liver failures and four deaths (New York Times, June 29, 2006; December 16, 2006). The FDA issued warnings about the connection between Ketek® and severe liver damage in January and June of this year (Public Health Advisory, January 20, 2006; FDA News, June 29, 2006).
Sanofi–Aventis, the manufacturer of Ketek®, changed the drug’s prescribing instructions to warn people about the risk of liver failure in June of this year. The revision was made in bold type, but was not a prominent black–box warning.
Ketek® has been plagued with problems since its inception. A doctor who recruited patients for a study that allegedly led to Ketek®’s approval was later convicted of providing fake data. Three Congressmen have claimed that the FDA relied on biased foreign reports in their recommendation for Ketek®’s approval.
Sen. Chuck Grassley (R–IA) has gone as far as to say that the FDA intentionally withheld key information about Ketek® and liver damage from its own advisory panel that met in January 2003 (Press Release, December 13, 2006). That panel recommended Ketek®’s approval without having all the facts, Sen. Grassley contends. He presented a detailed Senate Finance Committee investigative report supporting these charges to FDA Commissioner Andrew von Eshenbach. (You will need Adobe Acrobat to open this file. If you do not already have this software, you may download a free copy from the Adobe Acrobat web site.)
Ketek® Side Effects
Ketek® is the brand name for the antibiotic telithromycin. The medication only treats the bacterial forms of respiratory diseases, having no effect on viruses.
Besides liver damage, other side effects of Ketek® include eye problems, headaches, nausea, dizziness, vomiting and diarrhea. You should not take Ketek® if you have myasthenia gravis, a disease in which the immune system attacks the muscles and nerves. Using Ketek® can make this condition much worse.
Your Ketek® Case
Brayton Purcell is concerned with the health problems faced by people who took Ketek®. If you or a family member suffered liver damage after taking Ketek®, please contact us. We will evaluate your case free of charge, answer your questions, and explain your legal rights.
Each state has a deadline for filing legal claims once you have been injured. Therefore, we suggest that you contact us as soon as possible to get legal information if you have been injured by an unsafe drug.