GLAXO WELLCOME DECIDES TO WITHDRAW LOTRONEX FROM THE MARKET
Glaxo Wellcome, of Research Triangle Park, NC, has informed FDA that it
will voluntarily withdraw Lotronex (alosetron hydrochloride) tablets from
the market. 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
severe constipation).
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 constipation.
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
www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm.

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