FDA warnings about potential side effects of a company's drugs can range from mildly annoying to crippling, as has been the case for Johnson & Johnson's
The FDA issued a warning regarding 30 post-marketing reports of acute pancreatitis in patients taking the drug. Most of them had other risk factors for developing pancreatitis -- gallstones, severe hypertriglyceridemia, and alcohol use -- but the FDA recommended that doctors advise all patients taking the drug that they should seek medical care if they experience severe abdominal pain, and discontinue use of Byetta unless another explanation for the pancreatitis is found.
Amylin and marketing partner Eli Lilly
While the number of patients who will go off the drug after developing pancreatitis is extremely low -- two incidences per 10,000 patients -- the big question is how many patients who have risk factors for developing pancreatitis will be removed from the drug by cautious doctors.
Investors will need to wait a quarter or two to get a handle on any decrease in sales, but after GlaxoSmithKline's
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