New Warning Issued Over Birth Control Patch




New Warning Issued Over Birth Control Patch

Johnson & Johnson and their subsidiary Ortho McNeil have issued a warning about their Ortho Evra birth control patch saying that the product exposes women to a much higher risk for blood clots and other potentially deadly side effects than it was previously reported.

The warning states that women will be exposed to 60 percent more estrogen than women using birth control pills.  This exposure rate is increased because the hormones found in patches operate differently than hormones found in birth control pills.  The report and warning was issued some four months after other reports suggested that patch users were dying and having blood clots three times more than women on the pill.

The FDA has distributed the new warning to health care providers under guidance.  Over 4 million women have used Ortho Evra since 2002.  Several lawsuits have been filed against the company over their sale of these damaging medications and many more are expected in the near future, particularly after this warning was issued.

Documents unveiled as a result of the lawsuits show that the company tried to conceal and create certain laboratory and scientific studies.  An internal memo dated from 2003 showed that Ortho McNeil officials did not want a study comparing Ortho Evra to the company’s Ortho-Cyclen pill because they were concerned that it might make their birth control patch look bad.

Because the patch delivers hormones gradually and all day, a woman is exposed to a much higher level for much longer periods of time than birth control pills, which tend to raise hormone levels but then taper off throughout the day.


 

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