KETEK

Ketek Liver Damage & Failure

On January 20, 2006, researchers reported three cases of severe liver problems, including one death, in patients at a North Carolina hospital after they began taking the antibiotic, Ketek (generic name of telithromycin). Federal regulators said they are examining an unknown number of U. S. cases involving Ketek and are consulting with overseas counterparts.

Ketek, manufactured by Sanofi-Aventis, was approved in 2004 for the treatment of acute bacterial infections from bronchitis, sinusitis and pneumonia. An FDA spokewoman said that the agency would examine its databases for other reports of liver problems in patients taking Ketek.

Dr. John Hanson, who works in the liver transplant center at Carolinas Medical Center, said that the severity of the cases warranted alerting doctors to a possible link between liver damage and Ketek. One patient at Carolinas Medical Center in Charlotte, N.C. died after taking Ketek. Another patient received a liver transplant, and the third contracted drug-induced hepatitis, but recovered after treatment with Ketek was stopped.

FDA Action

On May 19, 2006, the FDA was able to connect 12 cases of liver failure, which include four deaths to the antibiotic, Ketek. Based upon these findings, the FDA is urging Sanofi-Aventis, the manufacturer of Ketek, to add a warning label to the drug. Members of the U. S. government have been wary of the FDA’s approval of Ketek due to accusations of flawed information from one of the manufacturer’s tests. Ketek was refused approval by the FDA back in 2001 and 2003 due to the lack of safety information on the drug’s label.

Grassley is refused interview on controversial antibiotic
June 15, 2006 | Washington Post

After months of trying to get firsthand information from a governmental official familiar with Ketek, Senator Charles Grassley, R-Iowa, marched into the Department of Health and Human Services headquarters Wednesday asserting his congressional right to receive the data. After a brief meeting with senior HHS and Food and Drug Administration officials, Grassley departed empty-handed and angry.

"This is extraordinary to me," the senior Republican said outside the headquarters. "I haven’t had to go to an agency like this since 1983 to get information I requested.

"I smell a coverup," he said.

FDA officials denied any impropriety, saying they were cooperating with Grassley’s staff and had sent 400 boxes of documents relating to the approval and safety of the drug, Ketek. Some information had to be withheld, the agency said, because of continuing investigations.

The senator, a persistent critic of the FDA, said he went to HHS out of frustration over the agency’s refusal to make available one employee involved with an investigation into the antibiotic.

A powerful drug approved in 2004 for the treatment of chronic lung and sinus infections, it has been at the center of the newest controversy over the agency’s actions in reviewing new drugs and monitoring their safety.

Liver failure and disease associated with the drug have been reported, but the overriding issue involves the integrity of the clinical trials done to establish its safety and efficacy.

The agency acknowledges that there were major improprieties in a 25,000-patient clinical trial done for the drug’s developer, Aventis.

One person has gone to prison for fraud in connection with that trial, data from several other trial sites have been discarded because basic standards were not met, and the agency told the company it could not say anything about the trial results on its product label.

Nonetheless, the FDA allowed Aventis to use much of the data to support the company’s contention that the drug is safe. It also allowed Aventis to present the data to an FDA advisory panel without telling its members of the widespread fraud allegations clouding the trial.

Documents show that some FDA employees argued that the trial should have been discarded because of the company’s inadequate oversight.

Grassley has pressed to speak with an agent in the FDA’s Division of Scientific Investigations who, he said, "is key to understanding what the FDA did when it became clear that the safety study required by the FDA in order to approve the drug was fraudulent and faulty. Did FDA managers turn a blind eye and let the drug maker off too easy, or did the FDA do the right thing?

In reply, FDA spokeswoman, Susan Bro, said: "We would like to do whatever we can to help (Grassley) fulfill his constitutional duty as well as ours to the American people. However, we will not compromise an ongoing investigation."

FDA officials also said that having a senator interview a government investigator in the midst of an inquiry raised the possibility of politicizing criminal proceedings.

Ketek is one of the few antibiotics developed and approved in recent years. The agency has made a priority of encouraging companies to work in the field of antibiotics, which inevitably become less useful as bacteria become resistant.

Sanofi Suspends Ketek Clinical Trial Enrollment
June 9, 2006 | Reuters

French drugmaker, Sanofi-Aventis, has suspended the enrollment of pediatric patients into clinical trials to test its antibiotic, Ketek (telithromycin) following concerns about its safety.

The U. S. Food and Drug Administration said last month that it and Sanofi were discussing possible revisions to prescription instructions for Ketek after researchers had reported that three patients using it developed severe liver damage and one died.

"The trial recruitment of children has been suspended to have the time to analyze the benefit-risk relation of Ketek for pediatric use," a Sanofi spokesman said on Friday, adding that the decision was made following talks with the FDA.

Clinical trials for Ketek began in the middle of 2005 and since then Sanofi has recruited 1,100 children out of the 4,000 it aimed to test Ketek on, the spokesman said. It is being tested for ear infections and tonsillitis in more than a dozen countries, including the United States.

The treatment won marketing clearance in 2004 for respiratory infections although the FDA had rejected it in 2001 and 2003, asking for more safety information.

A newspaper reported on Thursday that a U. S. health official last month called for Sanofi-Aventis to halt the Ketek clinical trials because the drug could be deadly.

At the request of Europe’s drug regulator, Sanofi has already included stronger warnings about potential liver disorders on product information for Ketek.

Sanofi says in talks with FDA over Ketek label
May 19, 2006 | Reuters

French drug maker Sanofi-Aventis confirmed on Friday it was in talks with the U. S. Food and Drug Administration about its antibiotic, Ketek, following a report with the U. S. regulator wanted a warning label on the drug.

The Wall Street Journal, citing an internal FDA memo, reported Ketek had been linked to 12 cases of liver failure, including four deaths, and the FDA was recommending the company put a warning label on the drug.

"Sanofi continues to believe that Ketek is safe and effective," said a company spokesman in Paris.

"We are in talks with the FDA to evaluate secondary effects on the liver and as we are in discussions and we are not going to start commenting on these figures," the spokesman added, when asked about the alleged cases.

He said all secondary effects were reported to the FDA and talks on labeling had been going on for several months. He said the company did not have a copy of the memo cited by the newspaper.

The Wall Street Journal said U. S. lawmakers have questioned the FDA’s 2004 approval of the drug amid charges of faulty data from one of the trials.

Ketek, which was approved to treat respiratory infections, drew renewed scrutiny in January when researchers reported that three patients using the drug developed severe liver damage and one died.

The FDA rejected the drug in 2001 and 2003, asking for more safety information.

Mark Davis, P.C. is now handling claims for individuals who have developed jaundice, liver failure, liver disease, or any other liver abnormality as a result of using Ketek. Mark Davis, P.C. is experienced in pharmaceutical product liability cases and settlements. If you or a loved one has suffered from jaundice, liver failure, liver disease, or any other liver abnormality as a result of using Ketek, contact us at 1-800-277-0300.