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FDA Warns Consumers About Counterfeit Drugs
Purchased in Mexico
July 31, 2004 - The Food and Drug Administration
yesterday issued a warning about counterfeit drugs sold to Americans
from Mexican pharmacies. The FDA is warning specifically about
counterfeit versions of the drugs Zocor (simvastatin) and carisoprodol
that were recently imported from Mexico by individual Americans.
Tests indicate that the counterfeit Zocor did not
contain any active ingredient and that the counterfeit carisoprodol
differed in potency when compared to the authentic product. Carisoprodol
is a drug used in the treatment of painful musculoskeletal conditions
and Zocor is a cholesterol lowering drug. The counterfeit versions were
reportedly purchased at Mexican border town pharmacies and sold under
the names Zocor, 40/mg, (lot number K9784, expiration date November
2004), and Carisoprodol, 350/mg, (lot number 68348A). Patients who rely
on these counterfeit versions of the drugs could develop serious health
risks (with the counterfeit Zocor) or have insufficient pain relief
(with the counterfeit carisoprodol).
FDA has repeatedly expressed its concern about the
purchase by Americans of drugs from foreign countries. As demonstrated
by this incident, purchasers cannot assume that the products meet the
quality, efficacy, and safety standards of FDA authorized products or
that FDA is assuring the quality, safety, and efficacy of products
purchased from outside the United States.
Medications purchased within the US system for
prescription drugs have undergone rigorous testing and review to verify
their identity, potency, and purity and to ensure that they are safe and
effective for their intended use. In addition, there are safeguards to
help maintain the integrity of the products while in shipment to
pharmacies and prior to dispending to patients.
Anyone who may have recently purchased the above
described versions of Zocor 40/mg and Carisoprodol 350/mg from Mexican
pharmacies should consult with their physician as well as notify their
local FDA field office.
FDA is investigating this matter and working with
the Mexican authorities to ensure that further sale and importation of
these products is halted. |
