You'll find hundreds of files on cleft lip, cleft palate here on widesmiles.org.

This one is about: Propulsid - Warning!!

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Propulsid Warning!!!!

Hey - I know that a lot of the kiddos on CT are on propulsid so please read the following. I saw it on the news last night, and then someone sent it to me.

Here is the article.

Cindy

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FDA issues warning for heartburn drug

June 30, 1998

ROCKILLE, Md. (UPI) - The Food and Drug Administration strengthened the warning label for a drug treatment for night-time heartburn, after reports of 38 drug-related deaths in a five-year period. The new labeling for Propulsid, generically known as cisapride, has been revised to include information about the cardiac risks associated with the drug and to recommend that patients use it as a last resort for the treatment of heartburn. The FDA's action Monday is prompted by reports of severe adverse reactions to the drug, including heart rhythm disorders and deaths associated with the use of the drug in combination with certain other medications or with people who had particular underlying medical conditions. Thirty-eight deaths relating to the drug were reported in the U.S. from 1993 to 1998. However, the FDA cannot directly link the reported deaths to the drug. The new labeling and the "Dear Healthcare Professionals letter" from the drug's sponsor, Janssen Pharmaceutica of Titusville, N.J., emphasize the drug should not be used in patients taking certain antibiotics, antidepressants, antifungals, protease inhibitors, or various other drugs. The warnings also caution against using the drug for such disorders as congestive heart failure, multiple organ failure, chronic obstructive pulmonary disease which causes serious respiratory problems, and advanced cancer. Propulsid should also not be administered to patients with electrolyte disorders, such as hypokalemia or hypomagnesemia. Doctors are being advised that Propulsid should only be used in patients who have not responded to lifestyle modifications or if other drugs for treating nighttime heartburn are ineffective. The labeling also advises discontinuing the use of Propulsid if relief from nighttime heartburn does not occur. Health care providers should report any adverse events related to Propulsid to Janssen Pharmaceutica (800-526-7736) or to the FDA. Reports may be submitted to FDA by telephone (800-332-1088), by fax (800-332- 0178), or by mail using a postage paid MedWatch form from the back of the Physicians Desk Reference. The MedWatch report should be mailed to: MedWatch (HF-2), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

Copyright 1998 UPI. All rights reserved


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