The drug company is Sanofi-Aventis and the drug is telithromycin, better known by its brand name: Ketek.
Ketek is an antibiotic that treats bacterial infections associated with sinusitis, bronchitis and pneumonia. After the safety concerns and outright fraud described above, was it approved by the FDA? Of course it was! And now - two years after approval - some ugly chickens have come home to roost.
Here's the latest box score for Ketek adverse effects, according to a 6/29/06 Reuters report:
The FDA has received 12 reports of acute liver failure linked to Ketek
Four of those patients died
One patient required a liver transplant
The Times states that liver failure has occurred in 14 patients, and 23 others experienced serious liver injury. The Times also notes that Ketek may cause blurred vision and loss of consciousness. So it's no surprise really that SOMEONE at the FDA is up in arms about this drug.