FDA issues Caution for Tamiflu

Tamiflu (oseltamivir phosphate) is used to treat some types of influenza infection (the “flu”) in adults and children over the age of 1 who flu symptoms have only been noted for two days or less. Tamiflu has also been used in the same population listed above when they spend time with someone who has the flu or during a flu outbreak. Tamiflu works by stopping the growth and spread of the flu virus in the body, thereby decreasing the time an individual experiences the symptoms common with the flu.

Countries around the world have been stock piling this type of medication in case a worldwide flu pandemic erupts. However, concerns about psychiatric problems were brought to light last year after twelve children in Japan were noted to have died, and thirty-two experienced abnormal behavior after they took Tamiflu. Since those reports, the FDA has evaluated 103 reports of psychiatric problems from August 2005 to July of 2006. A large majority of the cases came from Japan, and two-thirds of the ill effected population were under the age of 17.

As a result, FDA officials felt it was important to issue the caution, which strongly recommends close monitoring of patients for abnormal behavior such as delirium and self-injury. A caution is a less serious note on a drug label than a warning. It is still not certain that the drug contributed to any of the reports of psychiatric problems.

The manufacturer of Tamiflu, Roche, added the new language to packet inserts and sent letters to the healthcare community regarding the new cautions. Roche pointed out that the psychiatric problems are rare given that Tamiflu has been administered to over 42 million people since 1999.

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References used:

Richwine, L. Tamiflu label will carry new caution in U.S. Retrieved December 2006 from http://www/nlm.nih.gov/medlineplus/new/fullstory_41278.html

Medline Drug Information: Ostelamivir. Retrieved December 2006 from http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a699040.html

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