Hormonal contraceptives have been associated with dozens of cases of Benign Intracranial Hypertension (BIH). The first lawsuits have already been filed by women who allege that drug-makers are not doing enough to warn about side effects of BIH, such as migraine headaches and incurable blindness.
What is Ortho Evra?
Ortho Evra is a birth control patch that prevents pregnancy by releasing hormones through a woman’s skin. The hormones in Ortho Evra include progestin (norelgestromin) and estrogen (ethinyl estradiol). Compared to women on typical birth control pills, women on Ortho Evra are exposed to 60% more estrogen.
Benign Intracranial Hypertension (BIH) is not “benign” — it disrupts the normal flow of cerebrospinal fluid, elevates pressure inside the skull, and causes painful complications. The most serious side effect is incurable blindness.
What is the problem?
It is unknown if Ortho Evra causes BIH, but birth control is a possible risk-factor. In the last few decades, dozens of cases have been linked to birth control. For example, one study published in 1995 described 56 cases in women who were using Norplanon. In early 2014, nine lawsuits were filed against Bayer by women who used Mirena and were diagnosed with BIH.
Ortho Evra and Migraine Headaches
About 21% of women on Ortho Evra reported headaches, and 2.7% reported migraines during clinical trials. This is not unusual — headaches are one of the most common side effects of birth control. They are also reported in over 90% of people with BIH. Left untreated, headaches from BIH can become very severe and persistent.
Higher doses of estrogen are generally associated with higher rates of side effects, such as blood clots. The Prescribing Information for Ortho Evra includes this information in a Boxed Warning, which is the strongest warning the FDA can require on a medication.
According to one study, women on contraceptive patches are nearly 8-times more likely to have a blood clot than women who do not use hormonal birth control.
The problem with blood clots is that they can potentially travel to the brain, interfere with the flow of cerebrospinal fluid, and cause a complication known as secondary intracranial hypertension. This syndrome is identical to BIH. The only difference is that doctors know what caused high pressure inside the skull.