Online pharmacy weblog

The Food and Drug Administration (FDA) is cautioning U.S. consumers
about dangers associated with buying prescription drugs over the
Internet. This alert is being issued based on information the agency
received showing that 24 apparently related Web sites may be involved
in the distribution of counterfeit prescription drugs.

On three occasions during recent months, FDA received information that
counterfeit versions of Xenical 120 mg capsules, a drug manufactured
by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers
from two different Web sites. Xenical is an FDA-approved drug used to
help obese individuals who meet certain weight and height requirements
lose weight and maintain weight loss.

None of the capsules ordered off the Web sites contained orlistat, the
active ingredient in authentic Xenical. In fact, laboratory analysis
conducted by Roche and submitted to the FDA confirmed that one capsule
contained sibutramine, which is the active ingredient in Meridia, an
FDA-approved prescription drug manufactured by Abbott Laboratories.

While this product is also used to help people lose weight and
maintain that loss, it should not be used in certain patient
populations and therefore is not a substitute for other weight loss
products. In addition the drug interactions profile is different
between Xenical and sibutramine, as is the dosing frequency;
sibutramine is administered once daily while Xenical is dosed three
times a day.

Other samples of drug product obtained from two of the Internet orders
were composed of only talc and starch. According to Roche, these two
samples displayed a valid Roche lot number of B2306 and were labeled
with an expiration date of April 2007. The correct expiration date for
this lot number is actually March 2005. Pictures of the counterfeit
Xenical capsules provided by Roche can be viewed at
http://www.fda.gov/bbs/topics/news/photos/xenical.html.

Roche identified the two Web sites involved in this incident as
brandpills.com and pillspharm.com. Further investigation by FDA
disclosed that these Web sites are two of 24 Web sites that appear on
the pharmacycall365.com home page under the “Our Websites” heading.
Four of these Web sites previously have been identified by FDA’s
Office of Criminal Investigations as being associated with the
distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from
outside of the United States. Consumers should be wary, if there is no
way to contact the Web site pharmacy by phone, if prices are
dramatically lower than the competition, or if no prescription from
your doctor is required. As a result, FDA strongly cautions consumers
about purchasing drugs from any of these Web sites which may be
involved in the distribution of counterfeit drugs and reiterates
previous public warnings about buying prescription drugs online.