Reproductive health advisers to the United States Food and Drug Administration have recommended that the label of Johnson & Johnson’s birth control patch Ortho Evra be simplified to explain the risk of blood clots more clearly.
Voting 20 to 3 with one abstention, the panel said the current label for Ortho Evra inadequately reflects the risks women face by using it.
“I’m satisfied generally with what the content is for this label. It’s the understandability and presentation that needs some work,” Dr. Jacqueline Gardner, panel member and University of Washington professor said.
The FDA sought the experts’ advice as it reviews the safety of newer hormone-based contraceptives launched in the past decade. Although the agency is not required to follow their advice, it often does.
All birth control pills increase women’s chances of getting blood clots but the patch has been linked to an even higher risk than the pill as it contains a much greater amount of the hormone estrogen.
In a report published on Dec. 7, Bloomberg said Ortho Evra’s warning label has been strengthened three times since 2005, to comply with FDA’s directives that were prompted by hundreds of lawsuits filed against Johnson & Johnson by women who claimed the patch had caused blood clots in the legs or lungs. Court records show that the company paid at least $68.7 million to settle the claims, Bloomberg said.
Currently, Ortho Evra has a boxed warning stating that using the patch poses a higher risk for blood clots compared to older birth control pills.
But a new FDA study earlier this year showed that women using the patch were about 60 percent more likely to experience venous thrombotic events (VTEs)—or dangerous blood clots, another report by Reuters said.
In VTEs, blood clots occur in one of the body’s deep veins, like in the leg or pelvis, and may travel to the heart and heart. This could lead to stroke or death, even in young women.
Over the years, studies assessing Ortho Evra’s blood clot risk have reached differing conclusions, another report by the Associated Press said.
According to the AP, at least two studies found that patch users have twice the risk of blood clots as women taking birth control pills, but agency scientists said the data was not definitive.
Johnson & Johnson’s Ortho Evra patch, approved by the FDA in 2001, is used weekly and works just as well as other contraceptive drugs, allowing fewer than one unplanned pregnancy per year in every 100 women who use it.
Of all contraceptive alternatives to pills and intra-uterine devices in the US, the Ortho Evra patch is the second most popular behind the Nuvaring vaginal ring, according to IMS Health data.
Last year (2010), doctors wrote 1.6 million prescriptions for the patch, and sales reached $124 million, almost a 50 percent decline over the past five years.
Benefits outweigh risks
But while the Ortho Evra patch may carry a higher risk than oral contraceptives, the patch should remain available as an option for women who find it hard to take a daily pill, the FDA advisers said.
In a 19-to-five vote, the panel said that the benefits of Ortho Evra as the only contraceptive patch sold in the U.S. outweigh its potentially higher risk of dangerous blood clots in the legs and lungs.
“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 panel member Dr. Michele Orza, a George Washington University professor said.
Panelists said the patch could be especially useful for younger women who have difficulty sticking to a daily pill regimen.
“I have many teenagers and it’s the only method they’ll use—for them it’s the perfect method,” said University of Chicago’s Dr. Melissa Gilliam.
The Ortho Evra patch has been marketed for its convenience as an “option for busy women who are looking to simplify life.”
The same group of advisers also recommended a more detailed description of blood clot risks and more studies for a popular new generation of contraceptive pills that includes Bayer AG’s Yaz and Yasmin [Related: See Yasmin Side Effects]. The new gen pills contain the compound drospirenone, which has been linked to a higher risk of VTEs.
Ortho Evra does not contain that compound.
“Yesterday we were looking at just another pill—there was no additional benefit to offset additional risk,” Michele Orza, policy analyst at the National Health Policy Forum who represented consumers at the panel review, told Reuters.
“In this case (Ortho Evra), I think there is additional risk but it is a unique kind of product. There is no alternative (patch) for women who desire hormonal contraception but can’t take the pill for some reason.”
VTE: know the risks
Sometimes clots can develop within blood vessels. This process is known as thrombosis. These blood clots (thrombi) can develop in veins (venous) or arteries (arterial).
Venous thromboses can be superficial, causing discomfort but generally no serious consequences. But they can be deep venous thromboses (DVTs) that form in the deep veins of the legs or in the pelvic veins.
Since the deep veins return blood to the heart, if a part of a clot breaks off, it can travel to the right side of the heart and then to the lungs, causing a pulmonary embolism and, possibly, death.
Deep vein thrombosis (DVT) and pulmonary embolism (PE) are a major public health problem in the U.S., affecting about 300,000 to 600,000 Americans and causing 60, 000 to 100,000 deaths each year.
Factors that increase the risk of developing DVT include:
- Increased estrogen, from birth control pills, pregnancy, and certain medications
- Major surgery
- Immobility, such as being in the hospital and long travel
- Recent injury
- Certain chronic medical illnesses, such as heart disease and cancer
- Previous DVT
- Age (risk increases as age increases)
About half of people with DVT have no symptoms at all. For those who do have symptoms, the following are the most common and occur in the affected part of the body (usually the leg):
- Redness of the skin
- Pulmonary embolism
- Difficulty breathing
- Faster than normal heart beat
- Chest pain or discomfort, which usually worsens with a deep breath or coughing
- Coughing up blood
- Very low blood pressure or lightheadedness, or black out
If you have any of these symptoms, you should seek medical help immediately.