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Tylenol Side Effects Unveiled

September 25, 2010

-SirNatural-

The FDA has announced that it is investigating reports of at least 775 serious side effects, including 30 deaths, associated with Tylenol and other over-the-counter drugs recalled by Johnson & Johnson subsidiary McNeil.

The side effects were reported by consumers who experienced them after taking products involved in one of four McNeil recalls in recent months. The FDA will determine whether the drugs were directly responsible for any of the incidents. Thus far, researchers have determined that most of the deaths were not caused by the drugs, a source close to a Congressional investigation said.

The first word of side effects came in November 2009, when McNeil recalled five lots of Tylenol Arthritis Pain 100 count with EZ-open cap, after consumers reported an unusual odor that caused nausea, stomach pain, diarrhea and vomiting. One month later, the company expanded the recall to include all lots of the product.

The next month, after reports emerged of consumers experiencing feelings of sickness associated with a strange odor from other McNeil drugs, the company recalled an unspecified number of Tylenol, Motrin, Benadryl and other over-the-counter products. The recall concerned drugs produced between January 1, 2008 and April 30, 2010.

In May 2010, McNeil issued a separate recall for 50 children’s versions of its over-the-counter pain, allergy, cold and cough drugs due to severe concerns over their safety and quality. According to the company, the recall was a precautionary measure, not an action taken “on the basis of adverse medical events.”

Operations have been suspended at the factory responsible for producing the drugs, and the FDA has released a 17-page report detailing more than 20 violations that took place there. The FDA is also investigating hundreds of serious side effect reports associated with the recalled children’s drugs, including seven deaths.

The House Committee on Oversight and Government Reform launched its own investigation into the drug recalls.

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