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Tylenol Recall
Motrin Recall
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:
Julie McCawley & Stevens Johnson Syndrome
"Hope for a Cure"
Julie, who was diagnosed with Stevens Johnson Syndrome (SJS). SJS is a severe adverse reaction to medication. Julie was 10 months old when she had a grandmal seizure. She was prescribed Phenobarbital to control Idiopathic Epilepsy. Julie’s condition became worse and she suffered multiple blisters, leaving her face unrecognizable. Her mother took her to the doctor who diagnosed her with a viral exanthem and later that day changed the diagnosis to chicken pox. Julie still showed no improvement and four days later she was diagnosed with SJS.
