FDA Panel to Investigate Tamiflu’s Impact on the Brain After 55 Children Exhibit Abnormal Behavior

This week, a Food and Drug Administration panel will review the effect of the flu medicine Tamiflu on the brain. 55 children in the United States reportedly exhibited abnormal behavior and other brain effects after taking the medication. 22 of the cases included serious symptoms, such as delirium, convulsions, and delusions.

Globally, more than 1800 children who have taken Tamiflu showed similar effects worldwide. Five children in Japan died because of psychiatric or neurological problems. Seven adults died because of neuropsychiatric problems.

75% of the 48 million prescriptions for Tamiflu are administered in Japan. Last March, the Japanese government issued a warning that Tamiflu’s use be restricted in young people.

There is no concrete evidence to show that Tamiflu causes problems in the brain or abnormal behavior. Terry Hurley, a spokesperson for drugmaker Roche Laboratories, says flu patients who have not taken Tamiflu also showed these symptoms. However, if a child or adult was injured from taking Tamiflu, he or she may have grounds to file a dangerous drug claim or lawsuit against Roche Laboratories.

Tamiflu is Roche’s number nine best-selling drug and, according to the Tamiflu Web site, it is the “number one doctor-prescribed flu medicine.” The FDA has recommended Tamiflu for use in children and adults over age one. Tamiflu is used as a flu vaccine and to treat flu symptoms.

FDA safety reviewers are recommending that Tamiflu labels be updated to include information about possible neuropsychiatric side effects.

The FDA’s review of Tamiflu comes a little over one month after the makers of several infant cold medicines voluntarily recalled infant cold medicines Dimetapp, Robitussin, Pediacare, Triaminic, Little Colds, and Tylenol because of accidental overdose concerns.

Earlier this month in Chicago, a woman sued Walgreen Co. and McNeil for the wrongful death of her 4-month-old son who died after taking Infant Tylenol Cold Decongestant Plus Cough and Pediatric Drops-Cough Plus Cold, which are two over-the-counter medications.

FDA panel to review Tamiflu’s effect on brain, USA Today, November 26, 2007
Lawsuit alleges Illinois infant died from cold medicine ingredient; mother suing 2 companies, International Herald Tribune/AP, November 14, 2007
Makers Pull Cold Medicines for Infants, CNN.com, October 11, 2007


Related Web Resources:

FDA Questions the Safety Of Asthma Drugs for Kids, The Wall Street Journal, November 24,2007

In Maryland and Washington D.C., the personal injury law firm of Lebowitz and Mzhen represents clients who have been injured or who have lost a loved one because of a dangerous drug. Please contact Lebowitz & Mzhen today and ask for your free consultation with one of our products liability lawyers to discuss your case. Drugmakers are obligated to manufacture medicines to help people—not hurt them.

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