January 21, 2015 / 11:38 PM / 5 years ago

Counterfeit Cialis found entering U.S. by mail: FDA

(Reuters) - The U.S. Food and Drug Administration said counterfeit versions of the erectile dysfunction drug Cialis were found in the mail en route to a customer in the United States, and it is alerting consumers and doctors to be on the lookout for fakes.

FDA laboratory analysis showed the counterfeit versions contain multiple active ingredients, which if used could result in adverse effects or harm, the agency said in a notice posted on its website on Wednesday.

Genuine Cialis, a rival of Pfizer’s widely used Viagra, is sold by Eli Lilly and Co.

The FDA is not aware of any consumer adverse events related to the use of counterfeit Cialis, it said, adding that health care professionals and consumers should report any such problems related to the use of suspect medications to FDA’s MedWatch Adverse Event Reporting program.

There is no indication that the legitimate supply chain is at risk, so consumers can be confident that prescription medicines received through legitimate state-licensed pharmacies located in the United States are safe, the agency said.

It cautioned against purchasing prescription medicines online, noting that some websites may be selling unsafe products.

The FDA listed several differences in the packaging of the counterfeit bottle of 20 milligram Cialis seized in the mail, including different patterns and colors on the label and a misspelling of Cialis on the side of the bottle. The agency posted pictures of a genuine Cialis bottle and the counterfeit, highlighting the differences.

The origin of the counterfeit Cialis was not disclosed.

In late 2011, fake versions of Roche’s multibillion-dollar cancer drug Avastin turned up at several U.S. oncology practices, setting off an international investigation and heightened scrutiny of the pharmaceutical supply chains.

Reporting by Bill Berkrot; Editing by Christian Plumb

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