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FDA Investigates YAZ and Yasmin

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Medical research has demonstrated that newer birth control formulations containing a synthetic new progestin, Drospirenone, are more likely to cause venous thromboembolism (VTE) blood clots than older drugs. This data has lead the Food and Drug Administration (FDA) to consider new safety measures in meetings later this week. The increased risk is significant because VTE can cause heart attacks, strokes and blockages in lungs, (pulmonary embolism PE) or blood vessels, (deep vein thrombosis DVT) which can be deadly.

Yaz, Yasmin (manufactured by Bayer) and generic versions of the drugs use drospirenone which appears to reduce side effects found in older drugs, including bloating and mood swings. Evaluating the VTE risk of birth control drugs is difficult because all hormone-based contraceptive drugs increase the risk of VTE. Furthermore VTE risk can be increased by smoking, obesity or family history (genetic blood clotting defects).

Yaz, Yasmin and other generic pills containing drospirenone are the focus of a FDA discussion this week. Bayer says its studies have shown no difference in VTE risk between its drospirenone drugs and the older birth control drugs. But several large, independent studies suggest the risk with Yaz and similar medications is slightly higher. The latest analysis by the FDA estimates the risk of VTE with drospirenone-containing pills is 1.5-fold higher than other hormone-based contraceptives.

Introduced in 2001, Yasmin was the first birth control pill to use drospirenone, which appeared to have fewer side effects. The reformulated version of the drug, Yaz, was approved in 2006 with approval to claim on the label that it decreased acne and a severe type of mood disorder, Pre Menstrual Dysphoric Disorder, PMDD.

A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of VTE in users of its Yasmin birth-control pills, according to the FDA. David Kessler, the former FDA commissioner, in a document unsealed in federal court in Illinois, said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, in a 2004 review of Yasmin’s safety provided to the agency.

Bayer faces 10458 lawsuits filed in the federal court, over injuries allegedly caused by the drospirenone contraceptives. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. The first trials for pulmonary embolism are scheduled for January 9, 2012 in federal court in Illinois and January 23 in state court in Philadelphia.

Bayer’s contraceptives generated $1.58 billion in sales last year, making them the company’s biggest-selling drugs after Betaseron, a multiple sclerosis medication.

In October, the FDA warned that women taking the drospirenone pills were 74 percent more likely to suffer VTE blood clots than women on other low-estrogen contraceptives. The FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report. The agency set the Dec. 8 hearing to discuss the findings.

The FDA told Bayer in June 2003 that it was “very concerned” about the number of adverse events, particularly deaths, reported in Yasmin users, Kessler said, citing an agency letter to the company. This included six deaths in the U.S., five of which were first reported to the FDA after April 2, 2003, the agency said.

Bayer responded that its data didn’t show a higher risk for Yasmin. Internally, the company decided to produce a “White Paper,” to the FDA, which would be “a scientific write-up that lays out the issues,” according to a Bayer document quoted by Kessler.

The white paper would compare Yasmin to other oral contraceptives, covering multiple adverse events including venous thromboembolism (VTE) and pulmonary embolism (PT).

According to Kessler, an early draft reported, “Compared to the three other oral contraceptives, Yasmin has a several fold increase in the reporting rates for DVT, PE and confirmed VTEs.”

The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, U.S. District Court, Southern District of Illinois (East St. Louis).