Birth Control Patch Controversy or Cover-Up

Whether you’re using the Ortho Evra Transdermal Patch or considering its use for a birth control method, take heed of the recent FDA warnings and pass it on. In January, 2008 the FDA approved to update the labeling of the birth control patch. This update was a result of a new study which found that women using the patch were at a higher risk for developing blood clots than women using birth control pills. Ortho Evra is manufactured by Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson.

And I smell a rat...as does The Public Citizen’s Research Group. On May 8, 2008 this advocacy group sent a petition to the FDA to ban the Ortho Evra Patch due to the increased risk of blood clots and other serious side effects. The petition also requests for a gradual recall of the patch to allow women time to transition to a different form of contraception. The group wants the patch off the market within 6 months.

To add to the stench is a stunning article by Gardiner Harris and Alex Berenson in The Times on April 6. They write how Johnson & Johnson misled the FDA in reporting the results of the serious risks from the use of the patch. The warning about blood clots or venous thrombembolism (clots in veins that may travel to the lungs and cause pulmonary embolism which can be fatal) has only been on the Ortho Evra Patch label since 2005 although the Patch was FDA approved in 2001. According to this article:

"Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent."

These lawsuits include more than 3,000 women and families claiming that the patch caused heart attacks, stroke, and in 40 cases, death. Also, from 2002 to 2006, the FDA received reports of at least 50 deaths associated with the patch…hmm, there may be more than one rat here.

The problem with the Patch has been the conflicting information regarding the mixed results of two studies on the increase risk of blood clots. One study showed that patch users were twice as likely as birth control users to develop blood clots while the other study showed that patch users and pill users were equally likely to develop blood clots. It finally took a third study to show that, yes it is true, patch users are at a higher risk of developing blood clots than pill users.

Here’s the skinny on why the patch may put us at risk:
Ortho Evra is a contraceptive patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the bloodstream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the patch will be exposed to about 60% more estrogen than if they were taking the pill which typically contains 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including blood clots. Ortho Evra, which is applied once a week, has been considered a safe and effective form of birth control by the FDA when used according to the labeling. It is recommended that women considering this type of contraception,would be advised of the risk factors for serious blood clots against the risk of other birth control methods and even the increased chance of pregnancy if women don’t take their birth control pill daily.

The good news is that this May petition may force the FDA and J & J to decide whether the Patch has seen better days. As far as a convenient and effective birth control method for some women, why not reproduce a patch with a safer profile? Remember the demise of the Dalcon Shield IUD? We now have the option of a safer devise.

In the meantime, women would be wise to boycott the Patch and demand a newer and safer hormonal formulation...time will tell.

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