Propulsid (cisapride) Withdrawn From Market
Propulsid (cisapride) manufacturer, Janssen Pharmaceutica, announced in March they will stop selling Propulsid in the U.S. due to safety concerns.
Although Propulsid has never been officially approved by the Food and Drug Administration (FDA) for use in children, a number of pediatricians and other health care providers prescribe the medication for certain children with gastroesophageal reflux disease (GERD).
The FDA says that Propulsid has been associated with 341 reports of abnormal heart rhythms, including 80 reports of death. Most of these serious side effects occurred in patients with underlying heart conditions or in those patients taking other medications that interacted with Propulsid, leading to the irregular heart rhythm.
If your child is currently taking Propulsid, talk to your pediatrician about alternatives. Janssen Pharmaceutica will continue to distribute Propulsid until July 14, 2000, after which they will establish a special "limited-access" program, to help keep the drug available for certain patients who cannot be helped with other treatments.
For more information, talk with your pediatrician and visit the Janssen Pharmaceutica website at http://www.us.janssen.com. You can also call Janssen at 1-800-JANSSEN.
The above information is intended for educational purposes only and is not intended to replace the medical advice given to you by your child's own pediatrician, pharmacist, or other health professional. Use of this online service is subject to our disclaimer.