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MoH for stronger warning on Tamiflu

ABU DHABI — The Ministry of Health (MoH) will insist on adding a stronger warning on the labels of Tamiflu that is commonly prescribed as a preventive medicine against influenza virus following reports of abnormal behaviour and deaths among children after its use and a recommendation for such a warning by the US Food and Drug Administration (FDA), a top health official has said.

“The FDA is our principal reference authority in terms of registration of medicines and post-marketing surveillance. We usually adopt the organisation’s instructions to ensure the safety of medicines available in the local market,” Dr Ali bin Shukur, Undersecretary of the MoH, told Khaleej Times yesterday.

Tamiflu, the most widely used flu drug in the world, should carry a stronger warning label about psychiatric problems seen in a handful of patients, a panel of experts from the FDA recommended.

The FDA experts recommended that drug maker Roche change the warning label for the medicine, which has been used by 48 million patients since its launch in 1999.

Last month, the drug’s manufacturer accepted the recommendation, according to an Associated Press report.

“We will consider the FDA’s recommendations, especially since the drug is manufactured in the US. The MoH will adopt necessary measures to ensure it is line with the organisation’s safety instructions,” Dr Shukur said.

The drug’s present label mentions reports of delirium and self-injury, primarily among children in Japan, but the FDA’s advisory panel said it should state that several patients have died as a result of such behaviour, AP reported.

Fifty-nine of the cases were classified as delirium with impulsive behaviour and self-injury.

Delirium, delusions, hallucinations or psychosis accounted for another 225 cases.

In total, five children died “as a result of falls from windows or balconies or running into traffic”, the safety review found. Three adults committed suicide. So far, there haven’t been any such cases reported in the United States, according to the FDA.

Tamiflu has been imported into the UAE in big quantities as a precautionary step to avert looming hazards of avian flu.