PHARMACY

FDA warns consumers about purchasing H1N1 ‘cures’ online

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Thursday warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning came after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.

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. When analyzed by the FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir. The Web site disappeared shortly after the FDA placed the order.

At the same time, 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. Several of the products purchased did not require a prescription from a healthcare professional.

Additionally, 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,” stated FDA commissioner Margaret Hamburg. “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.”

Consumers may not know exactly what they are getting when buying such antiviral products on the Internet from an unfamiliar company. 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. This may particularly be the case in the event of a public health emergency, such as an influenza outbreak, where approved treatment options would be in high demand and expensive, and where drug shortages could occur.

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).

Tamiflu and Relenza, in addition to their approved label, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency, the agency stated.

The FDA actively monitors the Internet, and where appropriate, will purchase and analyze drug products.

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Actress Olympia Dukakis, husband to appear in diabetes ads

BY Alaric DeArment

NEW YORK Passengers in New York taxis and viewers watching CNN at the airport will see actress Olympia Dukakis and her husband, Louis Zorich, talking about diabetes.

The appearance of the two actors won’t be in a movie, but in a public service announcement that’s part of drug maker Novo Nordisk’s “Ask. Screen. Know.” campaign to encourage diabetes awareness among the elderly.

The ad directs viewers to the Web site www.askscreenknow.com, which allows them to send voicemails and emails under Dukakis’ name encouraging them to undergo diabetes screenings paid for by Medicare.

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FDA approves generic epilepsy treatment

BY Alaric DeArment

PITTSBURGH Generic drug maker Mylan has received the Food and Drug Administration’s approval for its version of a drug used to treat epilepsy.

Mylan announced Thursday the approval of its topiramate sprinkle capsules in the 15-mg and 25-mg strengths. The capsules are designed to be opened and sprinkled onto soft food and are a generic version of Johnson & Johnson’s Topamax Sprinkle Capsules.

The branded version of the drug had sales of $58 million for the 12-month period ended June 30, according to IMS Health data.

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