Ketek: Sales Reps Push Profits over Safety

Andy Johnson is 35 years old, doesn't drink and has no family history of liver problems - there was no reason not to have a healthy liver. Until he took Ketek.

"My doctor prescribed Ketek for a sinus infection that was not responsive to other antibiotics and Ketek seemed to be the hot new drug at the time; this was around December 2005 and the Sanofi Aventis sales reps were aggressively pushing this product - I know because I work in the health community. I took it for about two weeks until I heard some disturbing news," says Johnson (not his real name pending a lawsuit).

"After reading headline news from MSNBC online about liver damage caused by Ketek, I went to the ear, nose and throat (ENT) clinic and asked for a liver function test... Within a few days the lab results came back and my doctor called: my liver enzyme count was off the rails! I was shocked.

My doctor told me to immediately stop taking Ketek. In fact the entire clinic erred on the side of caution and no other patient was prescribed this drug. After the first round of results came back, under the direction of my physician, I had bi-weekly tests to make sure enzyme levels went back to normal once Ketek was out of my system. Each set of results showed my enzyme levels almost cut in half - that was a good thing.

If I continued taking this drug my liver would have suffered irreparable damage. My doctor concurs. There must be a lot of people out there taking Ketek and not having their enzyme levels checked. Most alarming to me was that I had to bring it to the attention of this large ENT group. Subsequently they are no longer prescribing ketek to anyone, much to the chagrin of the Ketek representative. One reason I wish to remain anonymous is because my doctor told me the Sanofi Aventis sales rep blew a stack when they stopped prescribing Ketek at the clinic. It is a very large ear, nose and throat group so her sales must have taken a dive. Apparently she was pretty rattled - I don't want her to know me."

But a Ketek lawyer wants to know you.

More Ketek News
On March 30, 2007 the European Medicines Agency (EMEA) issued more restrictions on Ketek. It prohibited the use of Ketek for patients with a rare auto-immune disease called myasthenia gravis and gave a 'strengthened warning' of other side effects for all patients. The group added that 'severe problems with the liver have rarely been reported with Ketek but they do not occur more frequently than with other relevant antibiotic medicines.'
A statement from manufacturer Sanofi-Aventis said the strengthened EMEA warning notes the occurrence of 'temporary visual disturbances and transient loss of consciousness'.

Last month, the FDA restricted the prescription of Ketek to the treatment of pneumonia and no longer for less serious illnesses after it was linked to rare reports of severe liver problems, leading to several deaths.
Ketek is currently marketed in over 50 countries and more than 30 million courses of treatment with the drug have been prescribed worldwide to date.

In February, 2006 Health Canada issued a [warning], alleging Ketek may be associated with liver failure. The [FDA] hasn't been so vocal. Instead, it has so far remained neutral, saying that it is difficult to determine the actual frequency of liver problems associated with Ketek and that it is" continuing to evaluate Ketek's safety to determine if further action is needed." Does that translate to more people suffering irreparable liver damage before the FDA takes Ketek off the market?

Ketek: Sales Reps Push Profits over Safety

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