Hormonal birth control pills are a possible risk-factor for Benign Intracranial Hypertension (BIH). Bayer is now facing lawsuits from women who developed this side effect, which causes high pressure inside the skull, excruciating migraine headaches, and potentially permanent blindness.
What is Ocella?
Ocella is the generic form of Yasmin. Both medications are birth control pills that contain the same active ingredients. Ocella contains a combination of two hormones, estrogen (ethinyl estradiol) and progestin (drospirenone). It was approved for sale in the United States in 2008.
Benign Intracranial Hypertension (BIH) is not benign (harmless), which is why it is now known as Idiopathic Intracranial Hypertension (IIH). The condition occurs when there is too much cerebrospinal fluid inside the skull, which puts pressure on the brain and damages the optic nerves.
Side effects may include:
- Headaches: Migraine headaches may become increasingly common as the disease progresses.
- Papilledema: Swelling (edema) of the optic disc, which is located at the back of the eye. Diagnosed using an eye exam. May cause double-vision, blurry vision, temporary blindness, light-sensitivity.
- Blindness: Intracranial pressure can damage the optic nerve and cause visual field impairment and/or permanent blindness.
Does Ocella Cause BIH?
No one knows what causes BIH. There are no studies proving that Ocella causes BIH. However, there are numerous studies and case reports of BIH among women who were using birth control. Headaches were also reported by 10.7% of women on Ocella in clinical trials, although it is not clear that the side effect is related to BIH.
Bayer is currently facing a growing number of lawsuits from women who were diagnosed with BIH after using Mirena, an IUD that contains levonorgestrel. In 1995, a study published in the New England Journal of Medicine reported 56 cases of BIH among young women on Norplant, a levonorgestrel-containing birth control implant. There are also case reports in women on exogenous estrogen and birth control shots.
What is Secondary Intracranial Hypertension?
In April 2012, the U.S. Food and Drug Administration (FDA) published a Drug Safety Communication to warn that drospirenone, an ingredient in Ocella, was associated with up to a three-fold increased risk of blood clots.
Secondary intracranial hypertension is a rare complication that can occur when blood clots travel to the brain and block the normal flow of cerebrospinal fluid. The disorder has the same symptoms and complications as BIH. Both conditions cause high pressure inside the skull.