Anticipating a possible government recall order, the pharmaceutical giant Glaxo Wellcome Tuesday pulled its popular intestinal drug Lotronex off the market.
CBS News Correspondent Sharyl Attkisson reports most of the 300,000 women who've used the drug have done so without problems, but some have reported serious side effects.
The FDA approved Lotronex last February, hoping it could help hundreds of thousands of women suffering from painful diarrhea or constipation caused by a condition known as irritable bowel syndrome (IBS).
In just eight months on the market, Lotronex was linked to 54 cases of a severe and potentially fatal abdominal problem called ischemic colitis, and 20 more possible cases, including five deaths, listed in so-called "adverse event" reports submitted to the FDA.
Consumer advocate Dr. Sid Wolfe twice petitioned the FDA to ban Lotronex.
"To take a disease that is not life-threatening and treat it with something that doesn't really work much better than a placebo and wind up killing people or hospitalizing large numbers of people doesn't seem like a good trade-off," Wolfe said.
Even before Lotronex was approved, FDA scientists raised concerns about the very side effects that are now showing up.
One noted that Glaxo Wellcome found several cases of abdominal disorders in clinical trials, but "misleadlingly listed (all of them) as unrelated to the study This represents a potentially serious problem."
"It is very disturbing that (Glaxo) has totally ignored" it, warned the FDA medical officer.
Still, FDA officials decided Lotronex held promise as the first drug that could help so many people who suffer the misery of irritable bowel syndrome. The FDA rushed through its approval and, under pressure from Glaxo Wellcome, dropped their proposal to put special "black box" warnings on the label.
Within six months, there were so many reports of ischemic colitis that the company strengthened the warning label. Reports continued to pour in, doubling over the next two months.
Glaxo Wellcome Tuesday said it disagrees with the FDA's assessment of Lotronex, but still decided to address the agency's concerns by pulling the drug.
It's now the seventh prescription drug withdrawn from the market in the last two-and-a-half years.
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