FDA Warns of Counterfeit Prescription Drugs Purchased Online

December 29, 2007

Yael Waknine
The US Food and Drug Administration (FDA) is warning consumers and healthcare professionals of the risk for obtaining counterfeit drugs when purchasing prescription medications online, according to a news release.

The alert was based on information regarding 24 apparently related Web sites that appear on the pharmacycall365.com home page under the “Our Websites” heading, according to an alert sent yesterday from MedWatch, the FDA’s safety information and adverse event reporting program.

On 3 recent occasions, the FDA was informed that counterfeit versions of orlistat 120-mg capsules (Xenical; Hoffmann-La Roche, Inc) were being supplied by 2 of the Web sites. None of the capsules contained orlistat; one contained sibutramine (Meridia; Abbott Laboratories, Inc) and the others were filled with talc and starch.

The latter were provided in blister packs stamped with a valid Roche lot number but displaying an expiration date of April 2007 rather than March 2005. The counterfeit products cannot be differentiated on sight alone as they closely resemble legitimate products (photos are available at http://www.fda.gov/bbs/topics/news/photos/xenical.html).

The Web sites involved in distributing the counterfeit orlistat capsules were Brandpills.com and PillsPharm.com, which appear on the same pharmacycall365.com page that is home to 22 other Web sites, 4 of which previously have been linked to shipments of counterfeit oseltamivir phosphate (Tamiflu; Roche Laboratories, Inc) and tadalafil (Cialis, Lilly ICOS, LLC).

These include AllPills.net, Pharmacy-4U.net, DirectMedsMall.com, Emediline.com, RX-ed.com, RXePharm.com, Pharmacea.org, MensHealthDrugs.net, BigXplus.net, MediClub.md, InterTab.de, Pillenpharm.com, Bigger-X.com, PillsLand.com, EZMEDZ.com, UnitedMedicals.com, est-Medz.com, USAPillsrx.net, USAMedz.com, BluePills-Rx.com, Genericpharmacy.us, and I-Kusuri.jp.

According to the FDA, the Web sites appear to operate from outside the United States. Consumers should therefore be wary if the company cannot be contacted by phone, if their prices appear to be extremely low, or if no prescription is required. Additional information regarding the purchase of prescription drugs over the Internet may be obtained online at www.fda.gov/buyonline/.

Healthcare professionals are encouraged to report potentially counterfeit drugs to the FDA’s MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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