Letter Regarding Lotronex
from Dr. Janet Woodcock, Director,
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA) has received many letters about Glaxo
Wellcomes voluntary withdrawal of Lotronex (alosetron hydrochloride) tablets from
the market. I would like to thank all who have written to FDA for sharing their
thoughts and concerns regarding this action.
Most letters have focused on the severity of some cases of irritable bowel syndrome
(IBS) and the need for continued access to an effective treatment. I want to assure you
that we at FDA are concerned about people suffering from IBS. We have heard from patients
and health care professionals and are very aware that IBS can be a debilitating disease
that greatly affects quality of life.
FDA worked closely with Glaxo Wellcome both before and after Lotronexs approval
on February 9, 2000, to evaluate adverse events reported with the use of the drug, and to
develop ways to communicate the risks to health care professionals and patients. These
included public discussions with FDAs Gastrointestinal Drugs Advisory Committee,
updating the professional labeling of Lotronex and the development of a Medication Guide
for patients. You can find more details about these actions and additional information on
the Lotronex
Information Web Page.
After approval of Lotronex, FDA had to weigh the benefits experienced by many users of
the drug against the serious adverse events experienced by others. This risk benefit
evaluation was difficult because we were aware that many users of Lotronex did not
experience these adverse effects. However, FDAs view that unrestricted marketing of
Lotronex poses a significant risk to patients was based on a review of the severity and
types of reported adverse events. As of November 10, 2000, we had received numerous
reports of serious adverse events, including 70 cases of:
- ischemic colitis (intestinal damage resulting from reduced blood flow to the intestine),
- severely obstructed or ruptured bowel (complications of severe constipation), and
- death.
As we reviewed these reports, we discussed our concerns about patient safety with Glaxo
Wellcome on numerous occasions. As a result of these discussions, FDA offered the option
of a restricted distribution program to Glaxo Wellcome, as an alternative to marketing
withdrawal. A restricted distribution program would have permitted the product to remain
on the market under closely monitored conditions. The goals of a such a risk management
program include:
- safer use of Lotronex in appropriately informed patients
- continued access to Lotronex by severely affected IBS patients under closely monitored
conditions
- continued clinical studies of the benefits and risks, and safe use of Lotronex.
After the discussions, Glaxo Wellcome chose to voluntarily withdraw Lotronex from the
market. However, FDA is ready to work with Glaxo Wellcome, as with any sponsor, to develop
risk management plans to ensure appropriate patient access to medically important,
effective drugs.
Be assured that FDA is committed to working with pharmaceutical sponsors to facilitate
the development and availability of treatment options for patients with IBS.
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
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Last Updated: March 08, 2001
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