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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
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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:

Ocular
Side Effects

Topamax
GI
Pulmonary
IV Immunoglobulin

Zyprexa & DRESS

Zyprexa has been linked with a severe and life threatening condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS oftentimes has overlapping features with Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and acute generalized exanthematous pustulosis (AGEP). DRESS usually develops over several days, with onset between 2 and 8 weeks after starting a new drug, like ZYPREXA. DRESS usually starts with a high fever and skin rash. DRESS can lead to organ failure and death.

 

ZyPrexa packaging DRESS

 

On May 10, 2016, the FDA issued the following Safety Alert regarding Zyprexa: “Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions”

 

Zyprexa Therapy

Zyprexa is an atypical antipsychotic approved by the FDA to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder. Zyprexa may also be used off label to treat symptoms of psychiatric conditions other than schizophrenia and bipolar disorder.

The manufacturer of Zyprexa has not disclosed to consumers or physicians in its label the risks of DRESS in connection with Zyprexa use.

 

Treatment of Zyprexa Induced DRESS, SJS & TEN

Treatment of DRESS, SJS, and TEN consists of immediate withdrawal of all suspect medicines, including ZYPREXA, followed by careful hospitalized monitoring and supportive care. It is very important for patients presenting with a high fever and a rash, where a diagnosis of drug hypersensitivity syndrome is considered, to have blood tests as soon as possible.

The manufacturer of Zyprexa has not instructed Zyprexa users to immediately stop Zyprexa when they develop a high fever or rash.

 

Zyprexa Lawsuit

If you or your loved one has taken Zyprexa to treat symptoms of a psychiatric condition, and then suffered DRESS, SJS, or TEN, you may be entitled to compensation. Jensen & Associates has successfully represented hundreds of people with claims against drug companies wherein those persons suffered from DRESS, SJS and/or TEN. We would be pleased to evaluate your case.

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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

Tylenol
TEN in a Child

Can Cause Death
FDA & Tylenol


Naprosyn

Zithromax



Stevens Johnson Syndrome