FDA’s Decision to Approve Use of Expired Tamiflu to Fight H1N1 Flu Virus Raises Red Flags
The Food and Drug Administration today announced it will allow the use of certain lots of expired Tamiflu for Oral Suspension as part of the federal government’s response to the 2009 H1N1 Influenza public health emergency.
In July, the FDA authorized the use of four lots of Tamiflu to be used as part of the government’s fight against H1N1, even though the lots had passed the expiration dates printed on their labels. Today, the FDA said it will allow another 17 lots of the drug to be administered to patients as part of the ongoing response to the H1N1 outbreak.
The expired lots of Tamiflu for Oral Suspension are part of the Strategic National Stockpile of drugs the government keeps on hand for use in public health emergencies. The Tamiflu lots in question have been tested through the federal government’s Shelf-Life Extension Program, the FDA said.
Under SLEP, the FDA conducts scientific testing and analysis to determine if certain drugs are acceptable for use beyond their expiration date. During testing, the FDA evaluates each lot to assure the quality and stability of the product. Through the SLEP testing process, the FDA has determined that data support the use of these lots of Tamiflu for Oral Suspension beyond their expiration dates, the FDA said.
Since H1N1 – also called “swine flu” – first appeared in March, the potentially deadly form of influenza has been blamed for sickening millions of people and killing thousands worldwide. Pregnant women, young children, the elderly, and people of all ages with weakened immune systems or other underlying medical conditions are at the greatest risks of dying or developing severe complications from the virus.
Is FDA Being Safe?
The fact that the FDA is resorting to such drastic measures and allowing expired drugs to be administered to patients to combat H1N1 is alarming. There is no doubt that H1N1 is an emerging threat to the health of millions of Americans and that the government should take all necessary steps to guard against its spread.
The question is: Should we be using drugs past their shelf lives? What adverse events, side effects, and health complications might come from using expired Tamiflu? Has the government done its due diligence in evaluating these risks and reaching the conclusion that Tamiflu for Oral Suspension is reasonably safe past its shelf life?
We will be monitoring this situation closely to ensure that people infected with H1N1 are not further injured by expired Tamifu.
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