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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:
Advil / Ibuprofen
ADVIL (Ibuprofen)
Manufacturer: Wyeth
Ibuprofen is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It is an over the counter drug primarily used to reduce the fever, pain, inflammation, and stiffness caused by many conditions, such as osteoarthritis, rheumatoid arthritis, and abdominal cramps associated with menstruation. Children's Advil is an over the counter drug primarily used to reduce fever in children.
FDA NSAIDs Decision Memo
SUBJECT: Analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk
Executive Summary
Following a thorough review of the available data we have reached the following conclusions regarding currently approved COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs)1 and the risk of adverse cardiovascular (CV) events:2
• The three approved COX-2 selective NSAIDs (i.e., celecoxib, rofecoxib, and valdecoxib) are associated with an increased risk of serious adverse CV events compared to placebo. The available data do not permit a rank ordering of these drugs with regard to CV risk.
• Data from large long-term controlled clinical trials that have included a comparison of COX-2 selective and non-selective NSAIDs do not clearly demonstrate that the COX-2 selective agents confer a greater risk of serious adverse CV events than non-selective NSAIDs.
American Osteopathic College of Dermatology, 2004 Erythema Multiforme However many drugs are trigger factors and a strong causative link has been found between antibiotics (especially sulfa drugs and penicillin's), NSAID's (drugs like Advil, Motrin and Naprosyn) and anti seizure medications (especially Dilantin and Phenobarbital).
By The Washington Post | January 2, 2007 FDA proposal stresses caution on painkillers
By Ricado Alonso-Zaldivar,Dec 2006 Stronger warnings urged for painkillers The FDA wants consumers to be aware that using over-the-counter drugs carries risk
WNDU 16 Health Resource Dec 2006 FDA Calls for Stricter Medicine Warnings
