FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers
The Food and Drug Administration recently posted the following press release on fda.gov:
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. Consumers are urged to review
the FDA Web page at www.fda.gov/buyonline/
for additional information prior to making
purchases of prescription drugs over the
Internet.
The 24 Web sites appear on
pharmacycall365.com.
* AllPills.net
* Pharmacy-4U.net
* DirectMedsMall.com
* Brandpills.com
* Emediline.com
* RX-ed.com
* RXePharm.com
* Pharmacea.org
* PillsPharm.com
* MensHealthDrugs.net
* BigXplus.net
* MediClub.md
* InterTab.de
* Pillenpharm.com
* Bigger-X.com
* PillsLand.com
* EZMEDZ.com
* UnitedMedicals.com
* Best-Medz.com
* USAPillsrx.net
* USAMedz.com
* BluePills-Rx.com
* Genericpharmacy.us
* I-Kusuri.jp
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01623.html
About The SafeMeds Alert System
The SafeMeds Alert System is a counterfeit alert
distribution service of the the Partnership
for Safe
Medicines--a group of
organizations and individuals that have policies,
procedures, or programs to protect consumers from
counterfeit or contraband medicines.