Bayer is facing a growing number of lawsuits from women who were diagnosed with Benign Intracranial Hypertension (BIH) after using certain forms of hormonal birth control. BIH occurs when excess cerebrospinal fluid puts pressure on the brain, causing painful migraine headaches and long-term complications, such as vision problems and blindness.
What is Yasmin?
Yasmin is a hormonal contraceptive (birth control pill) that contains a combination of two hormones the prevent pregnancy: drospirenone (progestin) and ethinyl estradiol (estrogen). Yasmin was approved by the U.S. Food and Drug Administration (FDA) in 2001 and it was sold by Bayer.
Yasmin and Benign Intracranial Hypertension (BIH)
No studies have provided conclusive evidence of a causal relationship between Yasmin and BIH. However, evidence linking BIH with birth control has been growing for decades. In 1995, researchers identified over 50 cases in young women (average age 22) on a contraceptive called Norplant that contained levonorgestrel (progestin).
More recently, a number of studies and case reports have linked BIH with other contraceptives, such as Mirena (an IUD containing levonorgestrel), exogenous estrogen, and progestin-only birth control injections. Bayer is currently facing several lawsuits from women on Mirena who were diagnosed with this disease.
- Migraines: As pressure inside the skull increases, headaches can become progressively more common and more severe. Over 90% of people with BIH report headaches. In clinical trials of Yasmin, 11% of women reported headaches or migraines.
- Papilledema: Swelling (edema) of the optic disc, which is the head of the optic nerve located at the back of the eye (blind spot). Symptoms may include double-vision, enlargement of the blind spot, blurry vision, and other problems.
- Blindness: This complication occurs when the optic nerve is damaged. Unfortunately, loss of vision is usually permanent.
Secondary Intracranial Hypertension and Blood Clots
The popularity of Yasmin has declined dramatically in recent years, after studies found that drospirenone (the progestin in Yasmin) could triple a woman’s risk of blood clots compared to older birth control pills. The FDA published a Drug Safety Communication about this risk in 2012.
Blood clots are also a potential source of secondary intracranial hypertension. Like BIH, this complication occurs when high levels of cerebrospinal fluid increase pressure on the brain. Symptoms and complications are similar. The only major difference is that secondary intracranial hypertension is known to occur when blood clots interfere with the flow of cerebrospinal fluid.