In March 2000, Lotronex, a drug for irritable bowel syndrome (IBS) developed by Glaxo, went on the market and was expected to reach sales of $1 billion a year. Glaxo had paved the way for the drug with a massive educational campaign about the ravages caused by IBS, which is characterized by bouts of severe diarrhea or constipation that sometimes alternate. The drug company had even sought and gained the support of a patient group called International Foundation for Functional Gastrointestinal Disorders. Despite all the public relations and lobbying, Glaxo ended up pulling Lotronex from the market in December 2000.
An estimated 300,000 persons had taken the drug during those nine months. In that time reports of severe side effects began to surface. Clinical trials had shown that Lotronex could actually worsen constipation; 27% who used it dropped out of trials due to constipation. Glaxo wanted to claim, in its warning labeling for the drug, that constipation was an "infrequent side effect." An October 1999 memo from FDA medical reviewer John Senior said: "This is inappropriate.... Constipation was NOT infrequent, but occurred in more than a quarter of the patients; it was COMMON, and almost to be expected." (It's a wonder that this drug ever got approved for IBS.) Also, according to John Senior, Glaxo "had 'buried in the fine print'" the occurrence of 4 cases of ischemic colitis (potentially fatal ulceration of the intestines) that occurred during trials. All 4 cases reportedly cleared up when the drug was no longer given. When the drug went on the market, the FDA began receiving reports of ischemic colitis that did not improve when the drug was discontinued.
According to this US News & World Report article, "FDA officials have learned to their dismay, doctors are overwhelmed trying to keep current on new drugs and their side effects and often don't read warning labels." In the case of Lotronex, relying on patients to prevent negative complications did not work either. Glaxo produced a 'medical guide' for using the drug, written for patients. In August 2000, the FDA required pharmacists to hand them out to patients who were taking Lotronex. Reports of serious side effects continued to rise. Eventually, Lotronex was blamed for over 70 hospitalizations/surgeries and 3 deaths. When the FDA planned to make Lotronex available only through specially registered doctors, Glaxo removed Lotronex from the U.S. market.
"A Pill Turned Bitter" by Joseph P. Shapiro, U.S. News & World Report, December 11, 2000.
COPYRIGHT 2001 The Townsend Letter Group
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