FDA officials authorize new test to diagnose 2009 H1N1 virus, caution about 'generic' Tamiflu

The FDA has authorized the use of a new test developed by the CDC to diagnose infections with the 2009 H1N1 influenza virus.

“This clearance represents several months of close collaboration between the FDA and the CDC,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health said in a press release. “This test is the second diagnostic cleared in recent weeks by the FDA for the 2009 H1N1 influenza virus.”

The CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel (IVD) can provide results within 4 hours and permits multiple samples to be tested at the same time. It will replace the former real-time RT-PCR Detection Panel, which received an emergency use authorization by the FDA during the initial stages of the pandemic in April 2009.

The new test can detect infections with sensitivity and specifically greater than 96%. It can separate and increase viral genetic material present in secretions taken from a patient’s upper respiratory tract. The enlarged viral genetic material provides a fluorescent signal and is analyzed by the Applied Biosystems 7500 Fast DX Real-time PCR Instrument.

In other H1N1 news, the FDA has cautioned consumers against buying a drug purported to be “generic Tamiflu” that has popped up on at least one website claiming to be an online pharmacy.

Without a prescription, the FDA procured a batch of the counterfeit drug through an Internet-based drugstore. The agency reported that the product, which arrived in an envelope postmarked from India, came in two foil-backed blister packages with the labels “Oseltamivir Phosphate 75mg TM-FLU Capsules” and “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD” printed on the back. Each packet had 15 yellow and tan capsules filled with white powder.

Tests revealed that the fraudulent medication showed no traces of oseltamivir — Tamiflu’s active ingredient — but contained cloxacillin — an antibiotic with properties similar to penicillin. Although no adverse reactions have been reported to the FDA, the agency said those with allergies to penicillin may experience similar, severe reactions, such as anaphylaxis, to cloxacillin.

The FDA reported that the website distributing the fake drug has since been shut down, but the product may still be available through other online pharmacies, and the agency has warned consumers about the dangers of frequenting Internet-based drugstores.

“A rogue Internet website marketing drug products may look like a professional and legitimate website but may actually be an illegal operation,” said FDA commissioner Margaret A Hamburg, MD. “Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated or have little or too much of the active ingredient.”

The FDA said it monitors Internet purchases and evaluates drugs carried by websites and online pharmacies, but some products may be missed. Consumers can protect themselves by learning how to identify legitimate online pharmacies that are licensed by the U.S. Board of Pharmacy. The National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, or the VIPSS Seal, is one indicator of an online drugstore that meets licensure requirements. A list of legitimate pharmacies is also available at www.vipps.info.

The FDA said anyone who has encountered or has possession of the fake Tamiflu should not use the product and contact the FDA’s Office of Criminal Investigations.