EU Says Tamiflu OK

Doctors from the European Medicines Agency on Friday announced that they believe the benefits of prescribing the anti-influenza drug Tamiflu outweigh the potential risk for severe psychiatric side-effects. The statement comes in response to Japan suspending administration of the drug to teens on Wednesday.

Japan previously called for the emergency suspension of use of the drug for children between the ages of 10 and 19. Over 57 different cases have been reported in Japan of youths who had taken Tamiflu committing suicide.

Reports of Tamiflu causing severe neuro-psychiatric effects that potential may lead to reckless and irrational behavior first surfaced over four years ago. The latest cases to be reported occurred last month in Japan when four teens who had taken Tamiflu attempted to kill themselves only hours later. In the unrelated incidents, two teens were successful in jumping to their deaths.

Roche Pharmaceuticals, the manufacturer of Tamiflu, released a statement on Tuesday claiming that the drug was not linked to an increase in psychoses. The press release by Roche cited previous, unrelated clinical trials that showed the number of psychiatric episodes in the general population to be the same as the number shown by patients who had been administered Tamiflu.

The statement released by the EU health committee on Friday says that while they will continue to monitor the situation in Japan, they see no reason to stop the use of Tamiflu. The group, "maintains its opinion that the benefits of Tamiflu outweigh its risks when the product is used according to the adopted recommendations."

According to the committee, the group recommended during a meeting in late February that changes be made to the packaging of Tamiflu to, "inform healthcare professionals and patients about neuro-psychiatric side effects. The recommended wording for patients is that, "Convulsion, depressed level of consciousness, abnormal behaviour, hallucinations and delirium have been reported during Tamiflu administration, leading in rare cases to accidental injury. Patients, especially children and adolescents should be closely monitored and their healthcare professional should be contacted immediately if the patient shows any signs of unusual behaviour."

Tamiflu is one of only a few drugs believed to be successful in treating the highly contagious bird flu.

In the United States, the Federal Drug Administration has yet to weigh in on the recent actions and statements of Japan, and now the European Union.

According to the FDA website, Tamiflu (oseltamivir phosphate) is approved in the United States as an oral anti-viral drug for the treatment of uncomplicated influenza in patients one year and older whose flu symptoms have not lasted more than two days. This product is approved to treat Type A and B influenza; however, the majority of patients included in the studies were infected with type A, the most common in the U.S.

Sources: European Medicines Agency

Reuters

FDA