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Tylenol Recall
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FDA Stevens Johnson Syndrome Ibuprofen Citizen Petition
FDA Recommended Changes to the Ibuprofin/Motrin Labels
Motrin Prescription Label Never Published by McNeil or J&J
Report adverse events to FDA's MedWatch reporting system by completing a form on line at FDA's MedWatch
Faxing (1-800-FDA-0178) Mail using the postage-paid address form provided on line (5600 Fishers Lane, Rockville, MD 20853-9787) Telephone (1-800-FDA-1088)
Preventable Adverse Drug Reactions
Over 2 MILLION serious ADRs yearly
100,000 DEATHS yearly
ADRs 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths
Nursing home patients
ADR rate 350,000 yearly
Institute of Medicine, National Academy Press, 2000
Stevens-Johnson Info:
Topamax
Manufacturer: Ortho McNeil Pharmaceuticals
Generic Name: Topiramate
Topiramate is an anti-seizure medication (anticonvulsant) that works in several ways to prevent seizures and migraines.
Topiramate is used to treat epilepsy and to prevent migraine headaches. For epilepsy, topiramate can be used alone or in combination with other epilepsy medications. For migraine prevention, topiramate is used to treat adults who have 4 or more migraine headaches a month and who have not responded to, or cannot take, medications that treat an acute migraine attack.
Date Created: 11/30/2001
Revised Date: 03/17/2006
September 26, 2001
IMPORTANT DRUG WARNING
Dear Healthcare Professional:
We have updated the prescribing information for TOPAMAX® to provide new information about an ocular syndrome that has occurred in patients receiving topiramate. This syndrome is characterized by acute myopia and secondary angle closure glaucoma. This information is based on postmarketing experience in more than 825,000 patients.
As of August 17, 2001 there have been 23 reported cases: 22 in adults and 1 in pediatric patients. It is generally recognized that postmarketing data are subject to substantial under-reporting...
