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FDA operation to seize unapproved drugs

More than 14,000 dosage units of unapproved drugs worth over $100,000 have been seized in an operation by the US Marshals service.
More than 14,000 dosage units of unapproved drugs worth over $100,000 have been seized in an operation by the US Marshals service.

The US Food and Drug Administration (FDA) announced that it had asked the US Marshals to conduct the operation. Originating in China, the drugs had been marketed as treatments for erectile dysfunction (ED) despite being labelled as natural supplements.

Margaret Glavin, associate commissioner for regulatory affairs at the FDA, said: "The FDA will not tolerate companies marketing unapproved drugs - products that have not proven to be safe or effective - as dietary supplements."

"The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products," she added.

The FDA launched an investigation into the supplier, Shangai Distributors, in response to a consumer complaint. Some of the unlisted ingredients found in the dosage units are used in FDA-approved ED prescription drugs.

However, the undeclared ingredients found in the stockpile of unapproved drugs seized during the joint FDA-US Marshals' operation can cause a dangerous lowering of blood pressure if they interact with nitrates. ED is common among patients with diabetes, hypertension, high cholesterol and heart disease as they often take nitrate-based medicines to treat their conditions.

Shangai regular, Shangai ultra, Super shangai and Natural super plus were some of the drugs including in the investigation. The FDA has advised consumers to stop using the medicines and contact their healthcare provider if they have experienced any adverse side effects.

10th April 2008

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