FDA red-flags dangerous counterfeit ED product

Pfizer ($PFE) and the FDA are often confronted with counterfeit Viagra that may not contain an active pharmaceutical ingredient (API). But in a new twist in the battle against fake erectile dysfunction (ED) drugs, the FDA is warning men they may have a counterfeit drug supplement that does contain the active ingredient in the little blue pill. And it could kill them.

On Tuesday, the FDA posted a warning that consumers should not use ExtenZe Maximum Strength, particularly men with diabetes, high blood pressure, high cholesterol, or heart disease. Lab tests, the FDA said, confirmed that the supplement contains sildenafil, and sildenafil is the API in Viagra and other prescription drugs, as Reuters points out. The problem is that men who take nitrates should not take sildenafil because it can cause their blood pressure to fall precipitously.

The product is apparently made to look like ExtenZe, a supplement made by Monrovia, CA-based Biotab Nutraceuticals. The real ExtenZe does not contain sildenafil. The FDA said consumers can tell if they have the counterfeit because it has the lot number 0512058 and the expiration date "EXP. May 16" stamped on the outer carton and embossed on the blister card.

Counterfeiting of ED drugs is big business. Viagra is Pfizer's most counterfeited drug and may be the most counterfeited drug across the board. The company has a vigorous program to track down counterfeits of its products and in a new move last spring started up its own web sales program for Viagra to take away one of the advantages that counterfeiters had. Some men would rather get their ED drugs discreetly and so turn to online pharmacies. But as Matthew Bassiur, vice president of global security for Pfizer, pointed out in May, there are real dangers in going to unapproved online retailers. "Counterfeit medicines often contain the wrong or incorrect levels of active ingredient, as well as potentially dangerous contaminants. Samples of counterfeit Viagra tested by our labs have contained pesticides, wallboard, commercial paint and printer ink," he said in a Pfizer release. Still, the counterfeiters roll on. In August, the Department of Justice said it had indicted two men who brought in tens of thousands of counterfeit and misbranded Viagra tablets from China.

- here's the FDA warning
- more from Reuters