For years, the birth control pill has dominated the market, but recently the Ortho Evra patch has offered a new form of contraception. The FDA approved the patch in 2001, but the product was criticized for its high risk of blood clots. The FDA revisited this issue and decided to keep the patch on the market.
The potential problem
Some studies have shown people using the patch are twice as likely to get blood clots compared to those using other forms of birth control. Other studies have the risk at 40 percent higher. Several studies were reviewed by the FDA, along with comments and concerns from physicians.
Blood clots can lead to heart attack, stroke and other medical complications.
What physicians had to say
“I have many teenager patients and it’s the only method they’ll use — for them it’s the perfect method,” said Dr. Melissa Gilliam of the University of Chicago.
The patch has been marketed to busy women, for those looking to “simplify life.” The patch only has to be changed once a week, rather than a pill, which has to be taken everyday at roughly the same time.
“There is no alternative in this range for women who desire hormonal contraception but can’t take the pill, so I think it is important to maintain that option,” said Dr. Michele Orza of the George Washington University.
The decision
In the end, the FDA voted to keep the patch on the market saying it is still a suitable option for those looking to avoid pregnancy. However, they did ask Johnson and Johnson, the maker’s of the patch, to change their label so the risks are clearly stated for patients to see.
About 1.3 million prescriptions for the Ortho Evra patch were written last year, which is down from 5 million in 2006.
