DESCRIPTION: Invented by the same scientist responsible for a popular migraine medication, Lotronex was withdrawn from the American market by U.K. giant, Glaxo Wellcome, on November 28, 2000 for fear of future public safety and because the Food and Drug Administration (FDA) recommended that black box warnings be used on future product inserts. The FDA approved the drug earlier this year.

Lotronex had been touted as a miracle drug for treatment of women with diarrhea-predominant Irritable Bowel Syndrome (IBS). As defined by the manufacturer, diagnosis of IBS is preceded by recurring three-month symptoms of abdominal pain or discomfort with either urgency, an increase in frequency of stool, or diarrhea not attributable to organic disease.

Lotronex causes some patients to develop ischemic colitis (a shortening of the blood flow to the colon) and severe constipation. Glaxo Wellcome reports that one in seven hundred patients will develop these problems. Lotronex is an antagonist of the 5-HT3 (serotonin) receptor located in the intestinal tract.

Major publications report the significant involvement undertaken by Glaxo Wellcome to educate the medical community of IBS. It has been reported that the company helped to fund an international meeting organized by doctors to establish a protocol for diagnosing IBS and that Glaxo Wellcome funded an extensive survey, finding that IBS exists far more frequently in the population. Glaxo Wellcome also solicited gastroentomologists to attend all-expense paid trips to conferences funded by the company. It is no mystery that the company sought to expand the Lotronex target market. Beginning with estimates of annual Lotronex sales volume to reach one billion dollars, Glaxo Wellcome became quite involved in educating doctors of the prevalence of Irritable Bowel Syndrome.

Glaxo Wellcome commenced three 12-week clinical trials to establish the safety and efficacy of Lotronex before submitting its application to the FDA. The trials failed to establish the safety and efficacy for use of Lotronex (r) by men, and therefore sought only FDA approval for use by women. The Lotronex label disclaims that "[i]n men, the safety and effectiveness of Lotronex have not been established." What has been discovered belatedly by the FDA is that the safety and effectiveness of Lotronex (r) had not been established by use for women either.

By June 2000, the FDA's concerns heightened with increased reports of serious adverse events. On June 27, 2000, the same FDA panel originally granting "fast track" approval of Lotronex, reconvened for what is seemingly becoming the next stage of the FDA approval process: reconsideration. At that hearing, ten year veteran of the FDA, Victor Raczkowski, recommended that Lotronex (r) become a member of that distinct class of pharmaceuticals known as the black box club. The black box is a visible warning displayed in a black border to alert prescribing physicians of serious side effects. Fearful of destroying Lotronex (r) sales volume, Glaxo Wellcome agreed instead to issue a "dear doctor" letter and strengthen label warnings a move that was too little, too late.

Glaxo Wellcome agreed to voluntarily remove Lotronex on November 28, 2000, consequent of meetings with the FDA earlier that day requiring affirmative action. According to the FDA, as of November 10, 2000, a total of 70 serious adverse events were reported from the time of the drug's introduction in February of 2000. Of these 70 cases, the FDA received 49 cases of ischemic colitis and 21 cases of severe constipation, including the three cases of death.

It has been estimated that approximately 300,000 Americans used Lotronex in the nine short months it was available. Glaxo Wellcome reports only 1 in 700 users of the drug will develop ischemic colitis, and warns doctors to discontinue the prescription if their patient develops signs of ischemic colitis-even though one year earlier the company's own survey revealed that most doctors misunderstood gastrointestinal problems.

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Last modified: 10/08/02