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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

Painkillers during pregnancy may be linked to abnormalities

The QUESTION Medications generally considered safe and reliable may have unexpected consequences when taken during a pregnancy. Might that be the case with pain relievers called NSAIDs (nonsteroidal anti-inflammatory drugs)?

THIS STUDY analyzed medical data on children born to 36,387 women; 2,571 of these babies were born with a birth defect. Women who had taken NSAIDs -- mainly Aleve (naproxen), Advil (ibuprofen), Vioxx (rofecoxib), Celebrex (celecoxib) and Cataflan or Arthrotec (diclofenac) -- during their first trimester of pregnancy were twice as likely to have had a child with a birth defect as were women who did not take such pain relievers. Heart defects, specifically cardiac septal abnormalities, were most common. [more]


Study Casts Doubt on NSAID Use After Brain Injury - Forbes.com

WEDNESDAY, July 26 (HealthDay News) -- Long-term use of the painkiller ibuprofen after brain injury led to a decline in cognitive abilities in rats, a new study found.

The findings may have implications for the treatment of patients with traumatic brain injury, because they are often prescribed ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) for chronic pain, said researchers from the University of Pennsylvania School of Medicine.

They published their findings online in the July issue of Experimental Neurology.


Hope for a Cure


Toxic epidermal necrolysis and Stevens Johnson syndrome: our current understanding.

French LE. Department of Dermatology, Geneva University Hospital and Medical School, Geneva, Switzerland. lars.french@medecine.unige.ch

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN, Lyell's syndrome) are now considered to be distinct clinical entities within a spectrum of adverse cutaneous drug reactions of increasing severity based on their surface of skin detachment. Within this spectrum, SJS which can be considered as a minor form of TEN is characterized by less than 10% body surface area of skin detachment, and an average reported mortality of 1-5%, whereas TEN is characterized by more than 30% skin detachment, and an average reported mortality 25-35%.

Both SJS and TEN are characterized morphologically by the rapid onset of keratinocyte cell death by apoptosis, a process that results in the separation of the epidermis from the dermis. Recent evidence is supportive of a role for inflammatory cytokines and the death receptor Fas and its ligand FasL in the pathogenesis of keratinocyte apoptosis during TEN. This Fas-mediated keratinocyte apoptosis that is the last step culminating in epidermal detachment in TEN can be inhibited in vitro by antagonistic monoclonal antibodies to Fas, and by intravenous immunoglobulins (IVIG) which have been shown to contain natural anti-Fas antibodies. Consequently, over the last few years, numerous case reports and 9 non-controlled clinical studies containing 10 or more patients have analyzed the therapeutic effect of IVIG in TEN. Taken together, although each study has its potential biases, 7 of 9 such studies point towards a benefit of IVIG used at doses greater than 2 g/kg on the mortality associated with TEN. These studies should serve as the basis for designing an appropriate prospective trial or for conducting a metaanalysis in the near future, in order to determine the therapeutic efficacy of IVIG in TEN. [more]

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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