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Tylenol Recall
Motrin Recall

FDA Links

FDA Science & Mission Risk

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

stevens johnson

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)

drug side effects
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:

Side Effects

IV Immunoglobulin

Shortening Drug Approval Times via Industry Funding of the FDA: Did Legislation Help or Hurt?

Wednesday, February 16, 2005

The FDA is charged with assuring the safety and efficacy of new drugs while also making them available to the public as quickly as possible. To help meet these competing pressures, Congress enacted the Prescription Drug User Fee Act (PDUFA) in 1992. This Act imposed performance goals on the FDA and allowed it to levy fees on pharmaceutical firms to provide the resources necessary to meet those goals. Although Congress has renewed PDUFA twice since it originally passed, there is little evidence on its effectiveness. This Joint Center conference will present and critically review some of the first empirical research on the impact of PDUFA on drug approval times.


FDA Medication Guide for NSAIDs

Non-steroidal anti-inflammatory pain drugs, NSAID's, are some of the most prescribed medications, and in general are used to relieve pain and inflammation.  They are also available in many over-the-counter medications containing Ibuprofen such as Advil Cold and Sinus, Advil Cold, Advil Allergy Sinus, Children’s Advil Allergy Sinus, Ibuprofen Cold and Sinus, Sine-Aid IB, and Children's Motrin Cold.

Based on the citizen repetition submitted in February, 2005, the Food and Drug Administration (FDA) has directed drug manufacturers to make labeling changes to Ibuprofen and other non-steroidal anti-inflammatory drugs that include additional warnings regarding the risks of Stevens - Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).

We tirelessly supported the citizen petition filed with the FDA to make the public aware of the possible risks related to these drugs and SJS/TEN.

In addition to the labeling changes for NSAID's, the FDA has published a user-friendly Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on their website. This FDA document lists life-threatening skin reactions as one of the possible serious side effects of NSAIDs.

FDA Safety News Articles

Video Tylenol
Motrin Recall

Side Effects

Other Drugs

Drug Reference

Drug Side Effects

Adverse Drug Event

Motrin can cause SJS & TEN, which can cause blindness, kidney failure, and death. What McNeil & J&J Have Never Told Parents.

Tylenol Liver Damage

TEN in a Child

Can Cause Death
FDA & Tylenol



Stevens Johnson Syndrome