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The Word is Out on Unapproved H1N1 Products

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Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) are the only two FDA-approved antiviral drugs for treatment and prophylaxis of the 2009 H1N1 influenza virus. In addition to their approved labeling, these drugs have been issued Emergency Use Authorizations by FDA that describe specific authorized uses during the H1N1 public health emergency.

Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs.

An Assortment of Targeted Products

FDA actively monitors the Internet and, where appropriate, purchases and analyzes drug products. In October 2009, it announced what it found when it purchased and analyzed several products represented online as Tamiflu.

One of these online orders resulted in delivery to FDA of an unmarked envelope postmarked from India. Inside were unlabeled, white tablets taped between two pieces of paper that were found to contain talc and acetaminophen, an active ingredient found in many medicines to help relieve pain and reduce fever. Not found was oseltamivir, the active ingredient of Tamiflu.

The Web site selling this product disappeared shortly after FDA placed the order.

The agency also bought 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. Several did not require a prescription from a health professional.

In actions it announced in June 2009, FDA issued warning letters and advised operators of offending sites to immediately ensure that they weren’t marketing products intended to act against the H1N1 flu virus that have not been cleared, approved, or authorized by the agency.

Among the unapproved, uncleared, or unauthorized H1N1 flu products it targeted at that time were

  • a shampoo said to protect against the H1N1 flu virus
  • a dietary supplement said to protect infants and young children from contracting the virus
  • a “new” supplement said to cure H1N1 flu infection within four to eight hours
  • a spray that claims to leave a layer of ionic silver on one’s hands that kills the flu virus
  • several diagnostic tests that have not been approved to detect the H1N1 flu virus
  • an electronic instrument whose sellers claim uses “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1 viral infection