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Why is Propulsid going to be available only to certain people?

Why is Propulsid going to be available only to certain people?


answer for 'Why is Propulsid going to be available only to certain people?'Propulsid (generic name cisapride) is a drug that's prescribed for the heartburn caused by gastroesophageal reflux disease (GERD). On March 23, 2000 the manufacturer, Janssen Pharmaceutica, announced that it will no longer market Propulsid in the United States. The manufacturer decided to take this action after reviewing reports of serious irregular heartbeats in people taking the drug. These side effects usually occur in people with certain medical conditions or who are taking medicines that interact with Propulsid.

Medical conditions that make these side effects more likely include heart disease, irregular heartbeats, kidney disease, lung disease, eating disorders (like anorexia or bulimia), dehydration, persistent vomiting, and low blood levels of potassium, calcium, or magnesium.

Medicines that can interact with Propulsid include certain antibiotics such as erythromycin (brand name Ery-Tab), clarithromycin (Biaxin), antifungals such as fluconazole (diflucan), itraconazole (Sporonox), ketoconazole (Nizoral), antiviral drugs (indinavir, ritonavir), antidepressants (nefazodone, amitriptyline, maprotiline), and anti-nausea drugs (prochlorperazine, promethazine). Grapefruit juice also interacts with Propulsid. This is not a complete list. Make sure to check with your doctor or pharmacist before taking any medicines in combination with Propulsid.

Because of these safety concerns, Propulsid is no longer available at drugstore.com. The manufacturer is only distributing it through a limited-access program. This is to ensure that Propulsid is used safely and only for those people who don't respond to other treatments. Enrollment for this program is based on criteria developed by Janssen Pharmaceutica and the Food and Drug Administration (FDA). Janssen is currently enrolling people in the Propulsid limited-access program.

What does this mean for you? If you take Propulsid, you should contact your doctor at your earliest convenience. The FDA recommends that you not stop taking Propulsid or any other medicines without first talking with your doctor.

For more information about Propulsid and the limited-access program, contact Janssen Pharmaceutica by calling 1-800-JANSSEN (1-800-526-7736) or 1-800-795-4247.

Sources:
U.S. Food and Drug Administration Talk Paper. "Janssen Pharmaceutica Stops Marketing Cisapride in the U.S.," FDA web site:http://www.fda.gov/bbs/topics/ANSWERS/ANS01007.html. Last accessed 11/2006.
"Limited-Access Program Announced in United States to Ensure Appropriate Use of Propulsid," Janssen Pharmaceutica web site: http://www.janssen.com/news/current/propuls_lim_acc.html. Last accessed 8/22/00.
Propulsid Medication Guide. Janssen Pharmaceutica, updated 1/00.
Micromedex Healthcare Series, Micromedex Inc., 2001.

This answer prepared 2/8/2001.
This information updated 11/22/2006.


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