ADELPHI, Md. - A panel of federal health advisers said Friday that a birth control patch from Johnson & Johnson probably carries a higher risk of blood clots than older drugs, but should remain available as an option for women who have trouble taking a daily pill. The Food and Drug Administration's panel of reproductive health experts voted 19-5 that the benefits of the Ortho Evra patch outweigh its risks, specifically a potentially higher risk of dangerous blood clots in the legs and lungs. Panelists said the patch can be especially useful for younger women who have difficulty sticking to a daily pill regimen.
So far, there is only a smattering of lawsuits alleging that Ortho-McNeil Pharmaceutical failed to adequately warn women of the high risk of blood clots from its popular birth control patch - but plaintiffs' lawyers say there is the potential for many more. Since its introduction in April 2002, more than 5 million women have used the Ortho Evra transdermal contraceptive patch. It's considered as reliable as oral contraceptives in preventing pregnancy, but is more convenient since it doesn't require women to take a pill each day.
ADELPHI, Md. A panel of federal health advisers said Friday that a birth control patch from Johnson & Johnson probably carries a higher risk of blood clot risks than older drugs but should remain available as an option for women who have trouble taking a daily pill.
(This article originally ran in Lawyers Weekly USA, Boston, MA, another Dolan Media publication.) So far, there is only a smattering of lawsuits alleging that Ortho-McNeil Pharmaceutical failed to adequately warn women of the high risk of blood clots from its popular birth control patch - but plaintiffs' lawyers say there is the potential for many more. Since its introduction in April 2002, more than 5 million women have used the Ortho Evra transdermal contraceptive patch. It's considered as reliable as oral contraceptives in preventing pregnancy, but is more convenient since it doesn't require women to take a pill each day.
A woman who sued a drug maker after her teenage granddaughter died while using a birth control patch has reached a settlement. Details of the agreement were confidential, court filings show. But an economist who helps attorneys gauge the value of losses in litigation laid out the steps he would take to reach a dollar amount in such a case.
Gingerly, Kathleen Thoren's family gathered around her in the intensive care unit, unable to speak to their beloved sister, daughter, wife, or even stroke her hands. The slightest stimulation might create a fatal amount of pressure on the 25-year-old woman's swollen brain, warned the doctors. We were horrified, but we tried to just quietly be with her," said her sister Erika Klein. "In the end, it didn't help.
The makers of a popular birth-control patch warnedmillions of women Thursday that the patch exposes them tosignificantly higher doses of hormones and may put them atgreater risk for blood clots and other serious side effectsthan previously disclosed. The warning from Johnson and Johnson subsidiary OrthoMcNeil, makers of Ortho Evra, says women using the patch willbe exposed to about 60 percent more estrogen than those usingtypical birth control pills because hormones from patches getinto the bloodstream and are removed from the body differentlythan those from pills.
The Food and Drug Administration warned users of thepopular Ortho Evra birth control patch that they are beingexposed to more hormones, and are therefore at higher risk ofblood clots and other serious side effects, than previouslydisclosed. Until now, regulators and patch-maker Ortho McNeil, aJohnson and Johnson subsidiary, had maintained the patch wasexpected to be associated with similar risks as the pill. But astrongly worded warning was added to the patch label Thursdaythat says women using the patch will be exposed to about 60percent more estrogen than those using typical birth controlpills.
Johnson & Johnson was sued by a Georgia woman who says she almost died from a blood clot after using the Ortho Evra birth-control patch, one of at least 17 such claims filed over the product. Sara Smith of Lawrenceville, Ga., was 17 in October 2003 when she developed pelvic, back and abdominal pain after using Ortho Evra for four months, according to the suit filed last week in U.S. District Court in Atlanta. Smith, since diagnosed with deep vein thrombosis, must take blood thinners for life and avoid contact sports, the suit says.
Question: My mom told me to stop using the birth-control patch because her doctor said it was dangerous. What's dangerous about it? Answer: It's not clear yet if the patch actually carries any increased risks for healthy young women, but I can certainly appreciate your mom wanting to play it safe until more is known. The concern that's arisen is whether the patch raises the chance of blood clots. Not the kind where your menstrual flow starts to glob up, which is no big deal, but the kind where blood circulating through your body in the veins or arteries forms a clot. If such a tiny plug-like thing then gets carried to your heart or lung or brain, it can cause death or other problems.
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