FDA Allows Use Of Unapproved Drug For Treatment Of H1N1 (Swine Flu) Virus

In previous posts, I discussed the availability of hospital beds to treat patients in the case of an H1N1 (previously known as Swine Flu) virus outbreak, and discussed the importance of hand-washing to prevent the spread of disease. In an effort to provide better treatment for patients who have already contracted the disease, the FDA (Food and Drug Administration) has issued an Emergency Use Authorization for a new drug that has not been previously approved for the treatment of this or any other disease.

Emergency Use Authorizations are typically issued during public health emergencies if there is reason to believe that the new drug may be effective, and that its potential benefits outweigh its risks. It is typically issued for a one year time period that can be renewed if the emergency has not subsisted.

Under normal conditions, for any drug to be approved by the FDA, it is required to show substantial evidence in clinical studies and should meet high safety standards.

The unapproved drug Peramivir, belongs to the family of neuraminidase inhibitors. It works by blocking the neuraminidase protein in the virus, thus preventing it from reproducing in the host (i.e. the patient’s) cells. It is given intravenously to certain adult and pediatric patients, once per day over 5 to 10 days.

There have been four studies in which Peramivir has been tested, with only 1,891 patients to have ever taken the drug. The known side effects include diarrhea, vomiting, nausea and neutropenia (reduction in white blood cells).

However, despite the limited data available, the FDA has decided to allow the use of the drug in order to provide alternative treatment options for patients with the disease. It is expected that additional complications may be observed, once the drug is given to patients with other medical conditions and that are taking other drugs.

Given that this is the first time ever that an Emergency Use Authorization has been issued for an unapproved drug, this is a sign that the FDA is taking H1N1 very seriously, as a severe, potentially fatal drug. As with all diseases though, an ounce of prevention is worth a pound of cure: always wash your hands and avoid close-contact with sick people!

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About Amer Kaissi

I teach courses and do research in healthcare management Amer Kaissi's profile Amer Kaissi's blog