FDA Warns of Fake H1N1 Drug Products Purchased Over the Internet
Yesterday, the U.S. Food and Drug Administration issued a warning to consumers regarding the purchase of H1N1 products over the internet. The warning included products claiming to diagnose, prevent, treat or cure the H1N1 influenza virus. The FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir).
One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets taped between two pieces of paper. These tablets were found upon analysis to contain talc and acetaminophen,. The tablets did not contain any of the active ingredient oseltamivir. The web site has disappeared since the FDA placed the order.
The FDA also purchased four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites. These products contained various levels of oseltamivir but were not approved for use in the United States. Many of these websites did not require a prescription from a health care profession. In addition, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.
“Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”
Drugs that are in high demand are vulnerable to counterfeiting and diversion because buyers may be desperate to stock the product, and criminals capitalize on the situation.
The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States. Consumers should contact their health care provider if they have any questions or concerns about medical products or personal protective equipment.
The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir). To be of use in treating H1N1, both are best taken with 72 hours of the onset of flu symptom.
The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products.
Consumers can also visit FDA's Web site for tips about how to protect themselves when buying medicines online.
FDA 2009 H1N1 (Swine) Flu Page