I have just issued a press-release on a recent CDC study evaluating the birth defect risk regarding Clomid. To view my press-release, please click the link below.
The FDA’s decision to order Darvon and other propoxyphene-containing products removed from the market on November 19, 2010, comes 5 YEARS after the pain reliever had been banned in Great Britain and a YEAR AND A HALF after it was withdrawn by all other members of the European Union. While other countries were taking strong regulatory steps to protect their citizens, the FDA’s reaction had been to simply increase the warnings on its risks. Darvon and its sister drugs have had a long history of drug addiction, suicide and cardiac problems since first entering the market in 1957. My question is this – why should it take 53 years to determine that a drug should not be on the market?
On October 8, 2010, the FDA announced that Abbott Laboratories would be withdrawing its weight-loss drug, Meridia (sibutramine) from the American market. Meridia was approved by the FDA for marketing in November 1997 for weight loss and maintenance of weight loss in obese patients and overweight patients with cardiovascular risk factors. The current action follows a study of 10,000 men and women, at or above 55 years of age, conducted between January 2003 and March 2009. The researchers reported a 16% increased incidence of a composite of non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest and cardiovascular death in Meridia users over those on a placebo. When looked at individually, there was a 28% increased risk of non-fatal heart attacks and a 36% increased risk of non-fatal strokes. Although these were meaningful risk factors, what prompted the FDA to take action at this time was the lack of effectiveness of the drug. The average loss of weight in the Meridia group over the controls after up to 60 months of treatment was only 2.5%. By way of example, a 200-pound patient would have maintained only a 5 pound loss after 5 years. The FDA thus concluded that the benefits did not outweigh the risks – the criterion for allowing a drug to remain on the market.
One more time the FDA had a chance to get it right, and one more time consumers took a back seat to industry. On September 23, 2010, the FDA decided to play Solomon by allowing Avandia to remain on the market, but at the same time place restrictions on who could use the diabetes drug and when. As stated by the FDA in its news release, “Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class.”
On May 20, 2010, researchers from the Harvard School of Public Health presented their findings from a study exploring the possible relationship between the use of fertility drugs and autism spectrum disorder (ASD). The scientists reported to attendees at the International Meeting for Autism Research in Philadelphia that women who used fertility drugs to get pregnant had almost double the risk of having a child with ASD verses nonusers. The drugs studied included Clomid (clomiphene citrate) and Pergonal (gonadotropin).
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