FDA teams up with Optivia Biotechnology to assess supplement-drug interactions

The U.S. Food and Drug Administration (FDA) and San Francisco-based Optivia Biotechnology have signed a collaboration agreement to assess the effect of dietary supplements on key drug transporters.

The issue of drug and nutrient interactions is a growing area of interest for both the nutrition and pharmaceutical industries. The new collaboration focuses on the identification of potentially harmful drug-dietary supplement interactions, such as an interaction with acetaminophen and other drugs associated with liver toxicity.

The research collaboration will assess the ability of various dietary supplements, including black cohosh, green tea, ginko biloba, kava, usnic acid and potentially others, to affect various drug transporters.

Starting with the seven transporters identified for drug-drug interactions and cited by the International Transporter Consortium (Nature Reviews-Drug Discovery, March 2010, Vol. 9, pp. 215-236, doi:10.1038/nrd3028), the collaboration will use Optivia’s transporter technology platform to extend this to supplement drug interactions.

According to Optivia, the platform features polarized mammalian cell assays that closely model human biology.

“This project further advances Optivia’s leadership position in the development of quantitative tools for optimizing the safety and efficacy of drugs,” said Yong Huang, PhD, president and chief executive officer of Optivia Biotechnology. “We are excited about this opportunity to expand the use of our technology to examine the role of dietary supplements in causing drug-related liver injury.”

As many as five percent of all hospital admissions and 50 percent of all acute liver failures are reported to be due to drug-induced liver toxicity. It is well established that transporters greatly influence the disposition by the liver of a number of commonly used drugs, such as antibiotics, statins, and hypoglycemic agents, and others that were subsequently removed from the market, such as the antidepressant nefazodone.

Works both ways

Drug-supplement interactions are also known to work in other ways, with some drugs and OTC medications known to sometimes inhibit the body's ability to absorb certain nutrients, resulting in nutrient depletions. Such interactions will not feature as part of the FDA-Optivia collaboration.

Other examples of supplements and drugs that may interact include gingko biloba with anticoagulants, and garlic with the platelet-inhibiting drug Tiplopidine and the anticoagulant Warfarin. Higher doses of certain drugs may be required if used in combination with glucosamine.