Tamiflu, one of the few drugs that can treat the feared avian influenza, could become widely counterfeited, U.S. officials cautioned on Monday.
The Food and Drug Administration set up a “rapid response team” to make sure enough of the legitimate drug could be manufactured in case of a pandemic of H5N1 avian flu.
And officials said they were sure there would be enough of the antiviral medication to treat Americans in the annual epidemic of seasonal flu, which kills an average of 36,000 people in the United States alone every year.
“We have begun to have some concern that there may be a threat of counterfeiting with respect to Tamiflu,” Health and Human Services Secretary Michael Leavitt told reporters in a telephone briefing.
The H5N1 strain of avian influenza is affecting flocks of poultry in many parts of Asia and into the eastern reaches of Europe. It has killed more than 60 people so far in four countries and while it does not yet easily infect humans, experts fear it will acquire this ability and cause a pandemic.
The virus is already resistant to one of four available influenza drugs, amantadine.
But two other drugs -- Roche AG’s and Gilead Sciences’ Tamiflu, and GlaxoSmithKline’s Relenza -- work against the virus. There is evidence that another older influenza drug called rimantadine may also work.
Countries scrambling to stockpile Tamiflu
Headlines about Tamiflu have created a furor, and countries are scrambling to stockpile it. Roche cannot make the drug fast enough to meet all the demand and says it will talk to other companies about licensing it to meet demand.
In the meantime, the Food and Drug Administration is worried about getting enough supply, and concerned that counterfeiters using the Internet may see an opportunity.
“The FDA has formed a rapid response team,” Acting FDA Director Dr. Andrew von Eschenbach told reporters.
“Presently, the agency is not aware of any counterfeit Tamiflu cases in the United States. However, there are initiatives in place to deter counterfeiters and parties who sell fraudulent or phony products to treat or prevent Avian flu,” the FDA added in a statement.
The agency also pledged to fast-track any potential new influenza drugs.
“In the event of a pandemic, such new medications could be made available under Emergency Use Authorization,” the FDA said.
Centers for Disease Control and Prevention Director Dr. Julie Gerberding said people did not need to worry that there would be a shortage of influenza drugs.
“Concern about Tamiflu is one that, I think, is not an evidence-based concern,” she said.
“While there have certainly been been more prescriptions for Tamiflu this year than last year, the manufacturer still has several million doses in the pipeline,” she added.
“At this point in time there is no evidence of a shortage that is going to result in any clinical impact on patients.”
Von Eschenbach said people should not try to wheedle Tamiflu prescriptions from their doctors to stockpile for themselves.
“One concern is that if citizens stockpile or accumulate this drug and begin to self-medicate ... that not only will undermine its effects, but will increase the possibility of an ... untoward or adverse effect,” he said.