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Thursday, May 27, 2010

FDA Investigating Reports of Side Effects of Tylenol

According to the Food and Drug Administration, there have been at least 775 reports of serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson. The drugs include Tylenol, Motrin, and Benadryl, but the reports do not only include the recalled drugs, recalled from the beginning of 2008 to April 30 of this year.

Many of these side effects lead to the deaths of consumers, including 30 from the recalls beginning in 2008, as well as seven deaths since May 1, 2010. This was the day McNeil recalled 50 versions of the children's brands of their medication due to quality and safety concerns.

The side effects are also officially known as "adverse events" and are consumer complaints of a serious side effect that is associated with the use of a medical product. Adverse events include an array of health complications, disability, hospitalization, and death.

This is the fourth recall of McNeil products in seven months. The others include:

  • Recall of five lots of Tylenol Arthritis Pain 100 count with EZ-open cap in November 2009 for unusual odor leading to nausea, stomach pain, diarrhea, and vomiting
  • In December 2009, the Tylenol Arthritis Pain caplet 100 count recall was expanded to include all lots
  • An unknown number of Tylenol , Motrin, and other over-the-counter drugs were recalled in January 2010 after consumers complained of feeling sick due to an odor

The recall of the children's drugs was done as a precautionary measure, according to McNeil.

The FDA issued a 17-page inspection report earlier this month detailing 20 different violations at the Fort Washington plant. The violations were described as "shocking" by a professor of pharmaceutical manufacturing at Temple University. He said it was the worst inspection report he'd ever seen and that the FDA found problems with almost every single system at the Pennsylvania plant.

If you or a loved one has become sick after taking Tylenol, Motrin, or Benadryl anywhere in the nation, please contact the experienced pharmaceutical injury attorneys at the Cochran Firm for an initial consultation.

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posted by Benjamin A. Irwin at 8:51 AM

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