November 28, 2000Lotronex Tablets Withdrawn from
Market After Reports of Adverse Effects, Including 5 Deaths
Triangle Park, NC (SafetyAlerts) -
Glaxo Wellcome has informed FDA that it will voluntarily withdraw Lotronex (alosetron
hydrochloride) tablets from the market after reports of serious adverse events, which
included 5 deaths.
Lotronex is a prescription medication
approved to treat Irritable Bowel Syndrome(IBS) in women. The FDA is advising patients
taking Lotronex to contact their healthcare providers to discuss treatment alternatives.
The company's action follows a
meeting held earlier today with the Food and Drug Administration (FDA) where the agency
discussed with Glaxo Wellcome risk management options that included restricting the
distribution of the drug or marketing withdrawal. Today's action follows FDA analyses of
the post-marketing reports of serious adverse events, which included 5 reports of death in
patients taking Lotronex.
Specifically, FDA has been concerned
about reported cases of intestinal damage resulting from reduced blood flow to the
intestine (ischemic colitis) and severely obstructed or ruptured bowels (complications of
As of November 10, 2000, FDA had
received and reviewed a total of 70 cases of serious post-marketing adverse events,
including 49 cases of ischemic colitis and 21 cases of severe constipation. Of the 70
cases, 34 resulted in hospitalization without surgery, 10 resulted in surgical procedures,
and three resulted in death. FDA has received two additional reports of death that the
agency did not classify as being cases of ischemic colitis or severe complications of
FDA has been closely monitoring the
drug since approval on February 9, 2000. Prior to approval, four cases of ischemic colitis
were observed in clinical studies and were discussed at a November 1999 meeting of FDA's
Gastrointestinal Drugs Advisory Committee. These cases were transient, mild-to-moderate in
nature and reversible upon discontinuation of the drug.
Between approval and June 1, 2000,
FDA received seven post-marketing reports of serious complications of constipation. This
resulted in the hospitalization of six patients, three of whom required surgery. During
the same time period, FDA received eight post-marketing reports of ischemic colitis. This
resulted in four hospitalizations, four endoscopic procedures,
and no surgeries.
On June 27, 2000, FDA convened a
public advisory committee meeting where risk management options in response to the serious
adverse event reports were discussed. No deaths were reported up to that date. The
consensus of the advisory committee members was that both physicians and patients must be
informed of the potentially serious adverse events associated with Lotronex.
Following the meeting, FDA updated
the healthcare professional labeling for Lotronex and required the drug's sponsor, Glaxo
Wellcome, to distribute a Medication Guide that warned patients directly about the risks
associated with the drug. In addition, at the request of FDA, Glaxo Wellcome issued
"Dear Healthcare Professional" and "Dear Pharmacist" letters to advise
these groups of the important new information.
FDA continued to receive severe
adverse event reports of ischemic colitis and complications of constipation associated
with Lotronex. In addition, FDA received reports of death and more serious complications
of ischemic colitis that required blood transfusion or surgery.
Upon completing its recent analyses
of the 70 cases, FDA's view of the options included marketing withdrawal or a restricted
drug distribution program. The restricted drug distribution program would provide: (1)
safe use of Lotronex in appropriately informed patients, (2) continued access to Lotronex
by severely debilitated IBS patients under closely monitored conditions, and (3) continued
clinical research into the benefits, risks, and safe and appropriate use of Lotronex. FDA
recognized that the other available treatments for IBS may offer inadequate relief from a
condition that can be severely incapacitating for some patients.
At the conclusion of today's meeting,
Glaxo Wellcome informed FDA that it will voluntarily withdraw Lotronex from the market.
For more information on this subject, visit the Lotronex Information web page created by
FDA's Center for Drug Evaluation and Research. The URL is
Notice of this product warning was
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