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alosetron (LOTRONEX)


DISEASE AND DRUG FAMILY INFORMATION

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Irritable Bowel Syndrome
The FDA has approved drugs for both diarrhea-predominant and constipation-predominant IBS. The former, alosetron (LOTRONEX) , had to be removed from the market after it caused serious constipation and a condition of decreased blood flow to the intestine called ischemic colitis. The latter, tegaserod (ZELNORM), has also been associated with ischemic colitis and severe, disabling diarrhea, and it is barely effective.

DRUG AND DIETARY SUPPLEMENT PROFILES

A comprehensive review of the safety and effectiveness of this drug. If the drug is not a Do Not Use product, information on adverse effects, drug interactions and how to use the medication are included.
Search results below include Drug and Dietary Supplement Profiles where your selected drug is a primary subject of discussion.

alosetron (LOTRONEX)
  • We list this drug as a Do Not Use drug because irritable bowel syndrome is not life-threatening, the drug is minimally effective and it causes lack of blood flow to the intestines and severe constipation.

WORST PILLS, BEST PILLS NEWSLETTER ARTICLES

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Important Drug Interactions for the SSRI Medication Fluvoxamine
December 2022
Patients taking fluvoxamine (LUVOX), a selective serotonin reuptake inhibitor (SSRI), should be aware that it has clinically important interactions with many other prescription and over-the-counter medications.
Update on Withdrawals of Dangerous Drugs in the U.S.
January 2011
This article lists 11 of the prescription drugs that we warned Worst Pills, Best Pills News subscribers not to use before they were banned by the FDA. Subscribers knew an average of 3.3 years before the FDA acted that these medications were unsafe to use.
Irritable Bowel Syndrome (IBS) Drug Alosetron (LOTRONEX) Withdrawn From the Market
January 2001
Glaxo Wellcome, the producer of the dangerous irritable bowel syndrome (IBS) drug alosetron (LOTRONEX), announced on November 28, 2000 that, at the request of the Food and Drug Administration (FDA), the drug would be withdrawn from the market. Alosetron caused numerous cases of ischemic colitis, a decrease of blood flow to the GI tract that can lead to inflammation, bleeding, and perforation of the GI tract resulting in infection of the abdominal cavity.

ADDITIONAL INFORMATION FROM PUBLIC CITIZEN

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Testimony to the FDA Drug Safety and Risk Management Advisory Committee on the Restrictions on the Use of Lotronex (HRG Publication #2141)
Public Citizen recommends that restrictions on Lotronex (alosetron) be tightened, rather than loosened, due to its high risk of life-threatening adverse reactions compared with its marginal benefits.
Testimony before FDA advisory committee concerning alosetron (Lotronex) (HRG Publication #1697)
New Data Reconfirms Dangers of Controversial Drug Lotronex
Allowing Lotronex Back on the Market Will Endanger Patients (HRG Publication #1622)
Reintroducing Lotronex onto the market as announced today by the U.S. Food and Drug Administration (FDA) will endanger patients, Public Citizen said today. Not only is the new marketing program too lax to prevent harm, but it is to be overseen by the company that makes the drug – a poor idea because the company has a financial incentive to downplay problems with the drug. Also, the recommended dose has not been shown to be effective.
Testimony Before FDA Advisory Committee Concerning Alosetron (LOTRONEX) (HRG Publication #1617)
From our analysis of adverse event data from the FDA and the FDA briefing documents, as of 12/31/01 there have been 352 hospitalizations associated with the use of alosetron, the majority associated with gastrointestinal adverse reactions, 85 cases of ischemic colitis and 13 deaths, seven of which show a strong association with alosetron according to the FDA.
Letter to the FDA concerning a memo from their Office of Post-marketing Drug Risk Assessment (OPDRA) that confirms and extends the dangers of the drug Lotronex (alosetron) for irritable bowel syndrome (HRG Publication #1566)
The updated AERS data we obtained, which extend through the end of calendar year 2000, now include a total of 63 people with ischemic colitis and 75 people with severe constipation (see graphs below).
Letter in Lancet on Alosetron for irritable bowel syndrome showing data manipulation in a company-sponsored clinical trial. (HRG Publication #1551)
Letter by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. in Lancet on Alosetron for irritable bowel syndrome showing data manipulation in a company-sponsored clinical trial.
Letter to the Food and Drug Administration updating the number of cases of ischemic coliitis reported in our 8/31/00 petition. (HRG Publication #1544)
We have just obtained new information from the FDA about a sharp increase in the number of reported cases of ischemic colitis in people using alosetron. As of October 20th, reports received by the FDA now include an additional 28 cases of ischemic colitis, a more than doubling of the number of 26 cases we reported as of August 28th, for a total of 54 cases of ischemic colitis.
Petition to the Food and Drug Administration to remove Lotronex from the market. (HRG Publication #1533)
Public Citizen, a nationwide consumer organization with about 145,000 members, hereby petitions the Food and Drug Administration to immediately remove from the market the drug alosetron (Lotronex, Glaxo Wellcome), a drug for the treatment of Irritable Bowel Syndrome (IBS) because, according to new information we have just received from the FDA as of August 28, 2000, it has been associated with a total of at least 26 cases of ischemic colitis.

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