Health Care Issues - Written by Beasley Allen on Wednesday, June 6, 2012 14:42 - 0 Comments

Some Birth Control Associated With Increased Blood Clot Risk

A new medical study has found that women who use patches like Ortho-Evra or contraceptive vaginal rings like NuvaRing have a heightened risk of blood clots. The study, released last month by the British Medical Journal, found:

Women who use transdermal patches or vaginal rings for contraception have a 7.9 and 6.5 times increased risk of confirmed venous thrombosis compared with non-users of hormonal contraception of the same age.

The conclusion was based on a study of 1.6 million non-pregnant Danish women from 2001 to 2010. The participants in the study had no history of thrombotic (clotting) disease or cancer. There has been a great deal of involving both patches, and vaginal rings have been the target of numerous suits throughout the country.

In 2008, Johnson & Johnson agreed to pay more than $68.7 million to settle the earliest cases brought by women who claimed their blood clots were caused by the Ortho-Evra patch. The patch must be worn for three consecutive weeks each month, to continuously provide hormones through the skin and into the blood stream. Thousands of lawsuits, filed in both state and federal courts, allege that Johnson & Johnson failed to adequately warn about the increased risk of blood clots. Stronger warnings have been added to the product’s label several times since the patch was introduced in 2002.

NuvaRing is a vaginal contraceptive that releases estrogen and progestin. Its main advantage is said to be convenience, because it can be left in place for three weeks instead of taking a pill every day. The device was originally manufactured by Organon Pharmaceuticals and its affiliates. Schering-Plough Corp. acquired the Organon entities in 2007. Merck in turn acquired Schering-Plough in 2009. Merck now faces hundreds of suits in state and federal court concerning the NuvaRing device. The lawsuits allege that NuvaRing has a design defect in the dosage and type of progestin used. Plaintiffs also claim that the manufacturers failed to warn about side effects, including blood clotting, pulmonary embolism, heart attack, stroke and deep vein thrombosis.

The just-released Danish study indicates that an increased risk of blood clots may justify a change in which products women choose to use. The study states:

A risk of 10 per 10,000 woman years implies a risk of venous thrombosis of more than 1% over a 10-year user period. Therefore women are generally advised to use combined oral contraceptives with levonorgestrel or norgestimate, rather than to use transdermal patches or vaginal rings.

If you need additional information on this subject, contact Melissa Prickett, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.

Source: Lawyers USA Online



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