FDA allows return of Lotronex
Physicians must take precautions before prescribing the previously recalled drug.
By Susan J. Landers, amednews staff. June 24, 2002.
Washington -- The Food and Drug Administration has decided to allow Lotronex (alosetron hydrochloride) back on the market. The drug was recalled in November 2000 after being linked to numerous reports of serious gastrointestinal adverse effects and several deaths during the 10 months it had been on the market.
The announcement marks the first time the FDA has reversed an earlier safety recall.
Physicians who plan to prescribe the drug, which was found by many to be effective at controlling irritable bowel syndrome, will first be required to enroll in a prescribing program run by the manufacturer, GlaxoSmithKline.
Enrollment in the program will be based on physicians' statements as to their qualifications to prescribe the drug and their agreement to educate patients on the risks and benefits of treatment with Lotronex. Physicians must also give patients the FDA-approved medication guide and report serious adverse events to GlaxoSmithKline (888) 825-5249 or to the FDA (800) 332-1088.
Patients will be asked to read and sign a patient-physician agreement before receiving their initial prescription for Lotronex. Pharmacists will be asked to fill only prescriptions that display a prescribing program sticker and to give patients an additional copy of the medication guide.
[...]
Full text of
American Medical News content is available to AMA members and paid subscribers.
Copyright 2002 American Medical Association. All rights reserved.
SHARE
