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FDA Approves Loryna, Then Names it in Blood Clot Safety Review

Jun 13, 2011 | Parker Waichman LLP

Loryna, a generic form of Yaz recently approved by the U.S. Food & Drug Administration (FDA), may put women at risk for a higher risk of blood clots.  Just weeks after the FDA approved the medication, the agency announced it was reviewing Loryna, along with Yaz, Yasmin and several other similar birth control pills, because of a possible increased risk of blood clots.  All of the birth control pills named in the FDA's Drug Safety Communication are made with a type of progestin called drospirenone.

All birth control pills carry a risk of blood clots, but in April,  two British Medical Journal studies reported that those made with drospirenone increased those risks significantly compared to pills made with levonorgestrel.  They were just the latest of several studies that have reached conflicting conclusions about drospirenone and blood clots.

The FDA is still evaluating data from a large study of 800,000 women that examined blood clot risks with all forms of oral contraceptives.   Those results should be available this summer, the agency said.

Drospirenone-containing birth control pills have become popular because some women tolerate this type of progestin better, and some side effects, like water retention, are less severe compared to other pills. But drospirenone is known to carry other risks. For one thing, it can impact the body’s potassium levels, which can cause a condition known as hyperkalemia, and lead to serious health complications.

Yaz, the only drospirenone-containing birth control pill sold in Canada, is also facing a safety review there because of blood clot worries.  Regulators in Europe have also ordered label revisions for drospirenone pills because of the recent blood clot findings.

Yaz, Yasmin and other drospirenone contraceptives have already been named in more than 6,000 U.S. lawsuits, many of which claim the drugs caused users to suffer blood clots.  Many of those lawsuits have been consolidated in a multidistrict litigation in federal court in the Southern District in Illinois (MDL No. 2100).  A partner in the firm of Parker Waichman LLP is a member of the Plaintiffs' Steering Committee in that litigation.

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