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Pharmaceuticals

Hundreds of sex and diet pills tainted with unapproved drugs – some dangerous, study shows

Erectile dysfunction drugs came up most in review of contaminated supplements in the FDA database, which also found Prozac in about 5 per cent of tainted weight loss products

PUBLISHED : Saturday, 13 October, 2018, 1:25pm
UPDATED : Saturday, 13 October, 2018, 6:39pm

Researchers found unapproved and sometimes dangerous drugs in 746 dietary supplements, almost all of them marketed for sexual enhancement, weight loss or muscle growth, analysis published on Friday shows.

The review of a Food and Drug Administration database of contaminated supplements for the years 2007 to 2016 most commonly turned up sildenafil – the drug sold as Viagra – and other erectile dysfunction drugs in sex enhancement products; sibutramine and the laxative phenolphthalein, both banned by the FDA, in weight loss supplements; and steroids or their analogues in muscle-building products.

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About 80 per cent of the supplements were contaminated by one pharmaceutical that should not have been in the product. Twenty per cent contained at least two such drugs, and two of the supplements contained six unapproved drugs. One product contained a drug that raises blood pressure and another drug that lowers it. Despite these contaminants, fewer than half the products were recalled.

This is someone spiking the product. They’re saying it’s a supplement. It’s not a supplement in any way, shape or form
Daniel Fabricant, Natural Products Association

The presence of unknown drugs in supplements “poses a serious public health risk”, the researchers wrote. More than 50 per cent of the US population consumes dietary supplements, and many consumers mistakenly believe the products are carefully regulated and accurately labelled.

The drugs found in the supplements have “the potential to cause serious adverse health effects owing to accidental misuse, overuse or interaction with other medications, underlying health conditions or other pharmaceuticals”, the researchers wrote.

Controversy over adulterated supplements stretches back decades. Under a 1994 law, the Dietary Supplement Health and Education Act, the products are regulated as food and so not subject to safety and effectiveness testing imposed on pharmaceuticals before they are sold. The US$35 billion supplement market includes multivitamins, minerals, botanicals and other products.

The new paper, written by a team from the California Department of Public Health, was published online Friday in JAMA Network Open.

Daniel Fabricant, president of the Natural Products Association, a supplement industry trade group, said it was unfair to consider sexual enhancement, weight loss and muscle building products in the same category as traditional dietary supplements such as vitamins. He said they are fringe products, often made by fly-by-night manufacturers and sold on the internet or in convenience stores.

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“We’re completely on the FDA’s side here,” said Fabricant, who used to work at the federal agency regulating supplements. “This is someone spiking the product. They’re saying it’s a supplement. It’s not a supplement in any way, shape or form.”

Fabricant said his organisation fully supports the FDA using its authority to bring misdemeanour charges against companies that adulterate supplements with drugs.

But Pieter Cohen, who wrote an editorial that accompanied the new study, said many tainted supplements actually come from well-known manufacturers based in the US. He cited a 2014 study that he and others conducted that found 20 of 27 supplements were still adulterated with drugs and available for purchase between eight and 52 months after they were recalled by the FDA.

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Cohen, an associate professor at Harvard Medical School who conducts research into the safety of dietary supplements, called on the FDA to more aggressively act against companies that produce adulterated supplements and urged reform of the 1994 law. He suggested that companies be required to register the products with the FDA before sale.

As the dietary supplement industry continues to grow in the United States, it is essential to further address this significant public health issue
California Department of Public Health report

A spokesman for the FDA said the agency would comment later.

The new analysis of the FDA’s Tainted Products Marketed as Dietary Supplements database contained some alarming findings about the three types of products. For example, the prescription antidepressant fluoxetine, or Prozac, was found in about 5 per cent of the weight loss products. Sibutramine, widely found in the weight loss products, can substantially increase blood pressure and pulse rate. The FDA withdrew it from the market in 2010 because of its potential to cause strokes.

The active ingredients in Viagra, Cialis and Levitra – widely found in the sexual enhancement supplements – can interact with nitrates found in medicine prescribed for diabetes, high blood pressure and high cholesterol and can dangerously lower blood pressure, the researchers said.

Men precluded from taking erectile dysfunction drugs may turn to these supplements, not realising they contain the very same pharmaceuticals, they said. Others may choose them because they are less expensive or because they are readily available in the US at service stations and convenience stores, Cohen said.

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“As the dietary supplement industry continues to grow in the United States, it is essential to further address this significant public health issue,” the researchers wrote.