FDA Officials, Warner-Lambert Knew of Rezulin Risks – (04-16-01)

FDA Officials, Warner-Lambert Knew of Rezulin Risks

Once again, I don’t mean to sound like I’m constantly bashing the use of pharmaceutical drugs. I want to stress the idea that, now more than ever, the situation is “buyer beware.” Unfortunately, this is very difficult to do without a full background in physiology, pharmacology and access to all the research. My thoughts on this are, since very few people are actually in a position to make such an informed decision, the best route is to avoid being the guinea pig for new meds and using most meds only after safer, more natural methods have failed.

(article) Warner-Lambert downplayed the potentially fatal risks associated with Rezulin during the approval process and received help from federal drug regulators in pushing the drug toward marketing approval, according to an article published in Sunday’s edition of the Los Angeles Times. The Times obtained company and government documents, as well as e-mail communications, which showed that Warner-Lambert officials had collaborated closely with certain senior officials within the US Food and Drug Administration during the approval process and later, when the company was being pressured to take the drug off the market. Rezulin (troglitazone) was initially approved by the FDA in January 1997 for treatment of type 2 diabetes. The drug was pulled from the market in March 2000 due to the number of reports of liver failure associated with use of the drug. At an FDA advisory committee meeting last year, regulators reported that there were 90 cases of liver failure among patients taking the drug since its launch.

James Bogash

For more than a decade, Dr. Bogash has stayed current with the medical literature as it relates to physiology, disease prevention and disease management. He uses his knowledge to educate patients, the community and cyberspace on the best way to avoid and / or manage chronic diseases using lifestyle and targeted supplementation.