• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Drug Linked to Liver Disease: Local Doctors Alert FDA After Cases of Death, Organ Failure, Jaundice

Posted on: Saturday, 4 February 2006, 12:00 CST

By Karen Garloch, The Charlotte Observer, N.C.

Feb. 4--A new antibiotic used to treat respiratory infections has been linked to severe liver disease that killed one Charlotte-area patient and caused another to need a liver transplant last year.

A third patient developed severe liver problems but got well once he stopped taking the drug, Ketek, according to doctors at Carolinas Medical Center.

Three cases of drug-induced liver disease in one hospital struck doctors as unusual, and they wrote about it for the Annals of Internal Medicine, a medical journal that published their report on its Web site last month.

"Is this just an incredible aberration or is there something more ... about this drug?" asked Dr. John Hanson, a co-author and member of CMC's liver transplant team. "We've raised more questions than we've answered at this point."

The CMC doctors also reported the cases to the U.S. Food and Drug Administration, which issued a public health advisory Jan. 20 warning doctors to monitor patients on Ketek. If patients notice any yellowing of their eyes or skin, they should get medical attention, the FDA said.

The significance of having three cases in one city, the advisory says, is unclear.

Ketek was approved by the FDA in 2004 for treatment of bacterial infections, such as bronchitis, sinusitis and pneumonia. Marketed by the French drug company Sanofi Aventis, the drug is effective against bacteria that have become resistant to older antibiotics.

None of the three patients was taking other drugs, and tests on the livers of two of the three showed the damage was caused by medicine, not alcohol.

"We advise caution in prescribing this drug pending further ... surveillance," the Charlotte doctors concluded.

A Sanofi Aventis spokeswoman said the company reviewed these and other reported cases and concluded that they "do not alter the drug's current safety profile." She added that infrequent cases of liver damage have been noticed in other antibiotics on the market.

The 3 CMC cases

The first patient, a 26-year-old man, arrived at the CMC emergency room in January 2005. He'd had a fever and jaundice for eight days, and was throwing up blood, said Dr. Kimberly Clay, a second-year resident in internal medicine and lead author of the journal article.The man had been taking Ketek for a runny nose and cough, she said.

During a procedure at the hospital, the man's heart stopped beating and he was resuscitated. He died two days later.

Then, in April, Hanson treated a 51-year-old woman who also had been taking Ketek for a runny nose and cough. She looked yellow and her liver enzymes were elevated, Hanson said. "She looked horrible, and she felt horrible."

Doctors treated her and waited for two months hoping she would recover, but in June, she got a liver transplant. "She's back at work and doing well," Hanson said.

He and Clay eventually compared notes about their patients and wrote the journal article to alert other doctors and patients to the potential danger. At some point, they learned that another colleague, Dr. Preston Purdum, had also treated a patient for liver problems that appeared to be related to Ketek.

That patient, a 46-year-old man, became ill in January 2005 while taking the drug for an ear and sinus infection. On the second day of taking the drug, he noticed a feeling of malaise and darkening of his urine. The next day, he developed jaundice and saw a doctor. When he stopped taking the drug, he began feeling better.

Instances elsewhere

By publicizing their cases, the Charlotte doctors hope to hear from other doctors or patients who have observed similar symptoms.

So far, Hanson said, he has been contacted by two doctors, in Shelby and Davidson, who had patients on Ketek who developed liver problems. They both got better, he said.

The FDA's advisory said patients on Ketek should not stop taking the drug if they aren't having unusual side effects.

As of June 2005, the FDA has received 10 reports of Ketek-related liver problems. It's unclear if any of the Charlotte reports were included in that number. But eight of those patients were also taking other drugs.

Karen Garloch: (704) 358-5078.

-----

Copyright (c) 2006, The Charlotte Observer, N.C.

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.

NYSE:SNY,

Source: The Charlotte Observer (Charlotte, N.C.)

More News in this Category