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FDA Seeks Comments on IBS Drug
Lotronex Was Withdrawn From the Market In 2000, but Some Want It Back
By Jennifer Warner, WebMD Medical News

Jan. 25, 2002 -- In response to repeated requests from people with irritable bowel syndrome (IBS), the FDA is now re-examining the status of the controversial drug Lotronex. 

Read the rest of this story here.



I was put on Lotronex in September, 2000, consistent with label instructions that this drug be prescribed only for those who did not have constipation as a part of their IBS. I had read reports of adverse events prior to beginning the medication, so I was cautious. After 2½ weeks at the recommended dose, I noticed a distinct slow-down in motility, so I cut back to ½ the recommended dose. My IBS was controlled wonderfully, with no adverse effects, for three months (remember that number). On Christmas Day I experienced a severe impaction which kept me in excruciating pain for two hours. My partner was ready to take me to the emergency room when, thankfully, the situation resolved.  Little did I know how lucky I was!

After this incident I did more research.  "FDA Moving to Revive Deadly Drug — Agency Director works with manufacturer to bring back Lotronex despite fatalities", a most compelling article by staff writer David Willman, appeared in the LA Times on May 30, 2001.  This article is archived at the LA Times website, although it costs $2.50 to retrieve the entire piece.  For those who'd like to purchase the article, click here.

The headline was enough to grab my attention, but what followed was quite disturbing. 

"Senior Food and Drug Administration officials are planning how to bring back to market a pill for a common bowel disorder despite new evidence that the risk of a life-threatening complication is far higher than thought when the drug was withdrawn in November, government documents show."

The article went on to describe FDA Drug Evaluation Center Director Dr. Janet Woodcock's private support of the drug to executives of its manufacturer, GlaxoSmithKline, and joint discussions between them about how best to 'orchestrate' returning the drug to market –to include structuring a public advisory committee meeting in an attempt to minimize criticism.  A GlaxoSmithKline executive expressed his concern that a public advisory committee meeting "would be a media circus and . . . that the advisors may disagree with what we have negotiated and put us back at square 1."  Dr. Woodcock, in an email to subordinates, indicated her assurance to the executive that "we can manage" the media. 

Lotronex was withdrawn from the market in November 2000 after five deaths and 12 cases of ischemic colitis had been linked to the drug.  By February 2001, Lotronex was suspected to be the primary cause of 11 deaths and 72 cases of ischemic colitis. 

The original product label cited ischemic colitis as an 'infrequent' occurrence in clinical trials.  By August, 2000, four months later, the label was changed to reflect a 1-in-700 risk.  Recently, however, FDA scientists found that patients who took the drug for three months [emphasis mine] or longer faced a higher risk of 1-in-218.  Dr. Zili Li, an FDA epidemiologist, said, "The longer a woman is on the treatment, the more likely it is that she will develop an episode of ischemic colitis. 

This is curious, since I don't know many people who have IBS for only three months.  It's a chronic condition which can last for years.  It would seem prudent that clinical trials be conducted for a longer period of time because of the chronicity of the condition.  It would appear this was not the case.

It was also found that almost 30% of patients developed mild to severe constipation, which, for some who went on to develop ischemic colitis, was the only sign of impending danger.

Terry Romeo of PA and her husband have filed suit against GlaxoSmithKline.  Terry experienced constipation less than one month after beginning Lotronex and stopped taking it.  After several days off the drug, she experienced severe pain and constipation, was taken to the emergency room, then brought to surgery.  It was discovered that she had ischemic colitis, her bowel was gangrenous, and her life was in jeopardy.  After a temporary colostomy, she said, "By the time I was hospitalized, it was too late.  This is not a drug that you want to play games with . . . As far as I'm concerned, that drug is lethal, and it should never be allowed back on the market.  Irritable bowel syndrome is an annoyance, but it's not worth risking your life for."

Even though I'd like to live a more 'normal' life, I'm in complete agreement with these statements.  Annoyance vs. the risk of death shouldn't be a decision that patients must make.  Isn't that what we rely on the FDA for? 

Dr. Woodcock has been denounced by the editor in chief of the Lancet, who stated, "This story reveals not only dangerous failings in a single drug's approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research in particular, has become the servant of industry."

Is this a drug I want back on the market? Not at the risk of what health I have left! I was, and continue to be, a prime candidate for this drug (no constipation here!). I was not part of the population that was considered 'at risk' for an adverse event. Yet AT ½ THE RECOMMENDED DOSE I still experienced severe constipation and impaction, not quite ischemic colitis but very painful and scary nonetheless.  In this writer's opinion, clinical trials for a period significantly longer than three months are necessary to insure the safety of patients on this drug.  Furthermore, the collusion between the FDA and the pharmaceuticals MUST be stopped so that the focus is put on the health and safety of the patient population, not the bottom line of the pharmaceuticals.


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