Wall Street Journal raises subatramine contamination question
Abott pulled the drug that entered the market in 2000 in the US and Canada amid links it could lead to increases in heart attack risk, prompting the Wall Street Journal to print an article quoting a physician stating some weight loss dietary supplements illegally contained sibutramine.
Despite the Food and Drug Administration having a highly active year in cracking down on dietary supplements making medicinal claims or illegally containing pharma ingredients, and amid new industry-supported GMP regulations that make contamination more difficult, Pieter Cohen, a physician at the Cambridge Health Alliance told the WSJ contamination was an issue.
Ethical standards and analogues
But he emphasized most of the activity was occurring on the internet and coming from suppliers located outside of North America.
“Things are particularly dangerous right now,” Cohen said in the paper’s Health Blog. He said, “the great majority of manufacturers are operating with high ethical standards,” but some overseas manufacturers have “continued to push the envelope in terms of manipulating the pharmaceutical compound” into so-called analogues, which make it harder for the FDA to detect the ingredients. Changing the compounds, “even subtly, is making a totally new chemical product that hasn’t been tested in humans.”
The FDA has a list of supplements it has identified as containing sibutramine that can be found here.
Of the list of 72 products it observes: “Many of these products do not list the manufacturer on the label or in the advertisements. However, most of the products appear to have been manufactured in China. We believe that BioEmagrecim is being imported from Brazil and Phyto Shape is manufactured in Malaysia. Star Caps was encapsulated in the U.S. but the raw product was allegedly imported from Peru.”
Of contamination in general it observed: “FDA takes this escalating issue very seriously, and is committed to doing all that it can to identify and remove these dangerous products from the market. However, unfortunately, it is not possible for FDA to test and identify all tainted products.”
Affirming its own ongoing activity in the area, the same day Abbott pulled Meridia the FDA issued a warning against a weight loss supplement found to contain sibutramine.
NutraIngredients-USA.com coverage of that can be found here.
Meridia withdrawal
Abbott’s voluntary withdrawal follows a European Union ban in January on all anti-obesity drugs containing sibutramine.
The company reaffirmed a positive risk analysis in the target population (those without history of heart disease) but agreed to withdraw the product after a 16-member FDA panel deliberated on whether to enhance labelling and risk management or issue a call for a withdrawal.
Health Canada had issued a warning about its potential risks.
"Despite these previous risk mitigation measures, there continues to be concern of an increased risk of heart-related adverse events, particularly as people at risk of cardiovascular disease may not have symptoms," Abbott said in a statement.
"In light of this concern, and the accumulating scientific evidence on the safety and efficacy of Meridia, it has been determined that the benefits no longer outweigh the risks for this drug."
