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FDA Recommended Changes to the Ibuprofin/Motrin Labels

Motrin Prescription Label Never Published by McNeil or J&J

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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

Keith Jensen obtained the largest verdict in NH history and that case is before the U.S. Supreme Court

Published: March 10, 2013

A New Hampshire woman who was severely injured by a generic drug in 2004 is still struggling to hold the manufacturer liable. Hercase will be argued this month before the Supreme Court, which has already severely limited the ability of consumers to sue generic manufacturers and may well limit it further. If so, some way must be found to compensate this plaintiff, Karen Bartlett, and others who have been hurt by generic drugs, which account for 80 percent of all prescriptions in this country.

Ms. Bartlett suffered a rare but severe reaction to an anti-inflammatory drug, sulindac, a generic form of the drug a doctor prescribed to treat shoulder pain. The reaction permanently damaged her lungs and esophagus, disfigured her face and body, and left her legally blind.

She sued the manufacturer, the Mutual Pharmaceutical Company, a subsidiary of an Indian drug maker, and was awarded $21 million by a Federal District Court jury in 2010. That amount included $16.5 million for pain and suffering, which Mutual challenged as excessive. A federal appeals court in Boston, however, upheld the verdict.




Hold Generic Drug Makers Accountable

Mutual appealed to the Supreme Court, which ruled in 2011 that patients could not sue generic manufacturers for failing to warn them adequately about drug risks because, under existing laws and regulations, the generic makers cannot unilaterally change warning labels. In this case, Ms. Bartlett is not arguing that there was a failure to warn but that the drug’s design is defective. Mutual contends that it has no more control over the design, which must mimic the brand-name drug being copied, than over the warning labels. The appeals court noted that Mutual could have taken a dangerous product off the market.

Manufacturers should bear responsibility for making sure their drugs are safe and effective. The Food and Drug Administration plays an important role by approving drugs based on limited clinical trials and then monitoring what happens when the drugs are widely used. But lawsuits are important, too, as deterrents to negligence or wrongdoing. If the Supreme Court shields the makers of generic drugs from consumer suits, Congress ought to amend the laws.


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Motrin Recall

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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