In March 2006, Trisha (not her real name pending a lawsuit) visited a local walk-in clinic complaining of flu-like symptoms; she was concerned because, as an HR consultant, she had to travel for her job. A nurse practitioner prescribed Ketek and soon as she got home, Trisha took two tablets and fell asleep on the couch.
"When I woke up I was feeling really sick and I had double vision - I couldn't see anything on the television," Trisha says. "I was nauseous and had a fever so the next morning I visited my primary care doctor - thank God I didn't take another dose of Ketek; it would have been so natural of me to get up in the morning and take the antibiotics.He put me on another medication but I was just getting sicker and my stomach was bloated - I couldn't go to the bathroom. That was Wednesday and by Saturday I was in hospital with a fever spiking at 103F and having a battery of tests to figure out why there was something wrong with my liver: they determined that I had elevated liver enzymes, but why?
A team of doctors tried to figure out what was wrong with me - I am only 53 years old and way too young to be sick; I was in perfect health and followed a healthy diet. But I was very dehydrated. After all the tests I had, from a CAT Scan to blood cultures to hepatitis and AIDS tests, they never discovered what caused my liver to be in this shape: there was so much pressure built up inside my liver that fluid was surrounding it.
I got home about a week later and looked on the Internet for liver enzyme information, trying to pinpoint the cause of my illness. I came across an article on a medical site regarding Ketek: a few people were reported dead, others had liver transplants and many more had elevated liver enzymes. The ones who had stopped taking Ketek were alive while the ones who continued taking this drug didn't make it.
For me, it is only by the grace and mercy of God that I didn't take any more Ketek. It took some time for my enzyme levels to return to normal. I was weak and very tired and had no energy at all -- I was off work for several weeks and definitely couldn't travel.
This whole illness was so bizarre. Surgeons were on standby the entire time I was in the hospital - maybe I would need my gallbladder out, or worse. It was frightening, and all from two tablets. As soon as I started researching, I saved the Ketek package - it has a lot number on it and I might be giving it to a lawyer. This stuff needs to come off the market.
If there is any monetary compensation, I don't really care, I am glad to be alive because for some people, Ketek has proven to be deadly.
My friend says she won't take anything that hasn't been on the market for years and Ketek was approved and first prescribed in 2004. I think she has a good point..."
In June 2006, the FDA completed a safety assessment of Ketek and advised health practitioners and patients "to be aware of rare but potentially serious health risks." In response, the manufacturer, Sanofi Aventis, is revising its drug labeling "to address this safety concern" and is advising both patients and doctors to be on the alert for symptoms of liver problems.