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FDA Requires Label Changes For The Patch

After cautiously clearing Yaz for continued use Thursday, an FDA Advisory Panel Friday addressed post-marketing data showing similarly increased blood clot risks among users of the contraceptive patch.  The committee, after having been clearly quite  extensively briefed,  heard testimony from Ortho Evra’s  manufacturer and experts in epidemiology, gynecology and hematology. They also heard moving testimony about  a young woman who died from a massive pulmonary embolism while using the Nuvaring, whose parents argued that not only the Patch, but most of the newer methods carry an increased clot risk that no woman should be allowed to take without being adequately informed.

The committee ruled that despite limitations of the data, the patch most likely carried a 1.5 times relative risk of blood clots compared to 2nd generation levonogestrel pills, but not necessarily higher than that of newer pills containing 3rd and 4th generation progestins and drosperinone.  With a few dissenters, the committee voted to allow the Patch to stay on the market, but asked for new product labeling outlining the increased clot risks.

The Power of a Good Graphic

The Committee seemed to be particularly moved in their deliberations by a visual presentation from  the manufacturer showing that the relative risks of Ortho Evra, while elevated compared to older second generation oral contraceptives, were comparable to that of other newer contraceptives – all of which have remained on the market. A summary slide presented by Anita Nelson, MD, showing absolute risks clustering in a similar range between the patch and other new progestin-containing pills, appeared to be equally compelling in this regard.

In perhaps a reaction to the power of a good graphic, the committee also very astutely recognized that current package labeling is ineffective in conveying comparative risks between methods for both clinicians and their patients, and asked for visual representation of risk in package labeling. They also spent sometime brainstorming how to best communicate risks to patients in general, recognizing that leaving it to the manufacturers may not be the best way to accomplish this important goal.

The Patch – A Unique Method for a Niche Market

The group’s decision on the patch appears to have been impacted in large part by the opinion that the method has a unique place among contraceptive methods due to its transdermal delivery system, even if it is that very system which may be imparting the increased risk.  Although dissenters pointed out that research has not shown the patch to have improved efficacy or compliance over pills,  anecdotal reports from members of the committee and gynecologist Dr. Anita Nelson stressed that for some of their patients, the patch was simply the only method they were willing and able to use.  This testimony from practicing physicians appeared to have influenced most of the  panel members, even those who argued initially that the method’s risks did not outweigh the benefit, that there was a niche group of women for women the method might still be appropriate.

As one member of the panel pointed out today, that niche has already been carved by adverse media reporting and the pull back of the manufacturer from DTC advertising and detailing of the method. As a result, the patch was now used by only about 2% of hormonal contraceptive users in 2010. It is this 2% that the Committee appeared to be considering in their decision top allow the patch to remain on the market. It’s a decision with which I have to agree.

Who are the patch users?

In my practice, they’re women who have breakthrough bleeding on every pill they try. Women using anti-seizure drugs that cause hormone levels in lower dose pills to drop below the range of efficacy. Women with estrogen withdrawal headaches on pills, who want the efficacy of a hormone but need the steady levels a patch provides (and aren’t willing to use the ring).  And women who have gotten pregnant on pills, don’t want an IUD or Depo, and whose partners won’t wear condoms.

Most importantly, they’re woman who’ve been advised that the price they pay for the benefits the patch provides is a slightly higher risk of blood clots, and who’ve accepted that risk in return for that benefit in what I believe is an informed choice. It’s not a large risk, but it’s a real risk, and they deserve to know it and be allowed to weight it in an informed contraceptive choice.

Hopefully, as a result of the FDA Panel’s deliberations today, the Patch’s (and other hormonal contraceptive method) package labeling will evolve from a medical legal document into a tool to support that informed decision making.

*This blog post was originally published at The Blog That Ate Manhattan*

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