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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

Don't Lose YOUR Rights:
At Issue: Consumers, Packaging And Promises

A STATE jury's verdict

Injured as a result of a manufacturing defect

Strict FDA-imposed penalties for concealing information from the FDA

Full disclosure to the FDA information about the risk at issue, and the FDA was fully informed about the risk when FDA approved labeling

In the view of Georgetown law professor David Vladeck, "Part of the issue in this case is whether the FDA has the capacity to monitor effectively all the 11,000 drugs on the market, post-approval."

Leading the Supreme docket is an issue that by the business community's WISH list: immunity from lawsuits for drug companies.

The shield that drug companies argue protects them from suit is a legal doctrine called pre-emption — meaning that Congress can write laws that give the federal government the exclusive right to regulate in an area, barring states from getting into the act.

Pharmaceutical firms are regulated by the Food and Drug Administration, but that alone does not pre-empt state lawsuits — and for decades, courts have ruled that lawsuits can still go forward against drug companies for failing to adequately label and warn consumers and doctors about either the dangers of a drug or the dangers in administering it.


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The information on this website is intended to be a public resource. It is also intended to be correct, but no promises or guarantees can be made or implied. In part, this is because the law and medical knowledge are sometimes subject to interpretation and often change more quickly than we can update the site. For specific questions, please give us a call.

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