The U.S. Food and Drug Administration (FDA) has released a warning to the public about bogus flu products that are targeting consumers via Websites and other promotional devices. The FDA and the Federal Trade Commission (FTC) issued the alert to consumers to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus (swine flu). Both agencies also advise operators of such Websites to take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.
“Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families,” said Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs. “In conjunction with the Federal Trade Commission, the FDA has developed an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”
The FDA said that such products offered for sale to the public with claims to diagnose, prevent, mitigate, treat, or cure infections caused by the H1N1 influenza virus that have not been proven safe and effective for these uses require careful evaluation. The FDA also explained that many of these deceptive products are being sold over the Internet through bogus Websites, with site operators capitalizing on the public’s fears about H1N1 influenza. These fraudulent products come in all varieties and could include dietary supplements or other food products, or products purporting to be drugs, devices, or vaccines, said the FDA, which noted that the fake products would not prevent the transmission of the virus or offer effective treatments against infections caused by the H1N1 influenza virus.
“The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies,” said FTC Chairman Jon Leibowitz. “The FTC will act swiftly against companies that resort to deceptive advertising.” The FDA Website offers tips on protecting consumers when buying medicines online at: http://www.fda.gov/buyonlineguide/
The FDA has approved two antiviral drugs for treatment and prophylaxis of the 2009 H1N1 influenza virus: Tamiflu (oseltamivir phosphate) and Relenza (zanamivir). Tamiflu and Relenza, in addition to their approved labeling, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.
In late 2006, the FDA alerted doctors and parents to watch for signs of bizarre behavior in children treated with Tamiflu after federal health officials noticed an increasing number of such cases overseas. There have been reports of 596 neuropsychiatric events, including 16 neuropsychiatric-related deaths, among children and adults taking Tamiflu, according to documents posted online at the FDA’s Website. Japan was also the origin of 81 Relenza reports and, according to Health Canada’s adverse reaction database, 27 people reported adverse reactions to Relenza, including one adult who died. One 14-year-old reported nightmares and another six-year-old temporarily lost consciousness. Another 96 people reported adverse reactions to Tamiflu, including 11 adults who died and nine who reported psychiatric problems.
There have been 12 reports of deaths in Japanese children since 2000; nearly all the new cases originated in Japan, where Tamiflu is prescribed about 10 times more often than in the U.S. The Japanese Tamiflu label now warns that disturbances in consciousness, abnormal behavior, delirium, hallucination, delusion, and convulsion may occur. It also recommends patients be carefully monitored and the drug stopped if abnormality is observed. The current U.S. label mentions only “seizure and confusion” seen in some patients. Most recently, Health Canada has been looking into reports that Relenza has been linked to deaths and abnormal behavior in children.
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