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Bayer is facing a growing number of lawsuits involving Benign Intracranial Hypertension (BIH). The Clark Firm, LLP has opened an investigation into the link between Ocella and BIH. Women who develop BIH may suffer from painful headaches and permanent complications, such as blindness.

What is Ocella?

Ocella is a birth control pill that has been on the market since 2008. It contains a combination of hormones that prevent pregnancy, including drospirenone (progestin) and ethinyl estradiol (estrogen). Ocella is the generic version of Yasmin.

Overview

Benign Intracranial Hypertension (BIH) is a brain injury that occurs when there is too much cerebrospinal fluid inside the skull. It can put pressure on the brain, which causes excruciating headaches. It can also damage the optic nerves, which can cause blindness. Because it is not “benign” (harmless), BIH is now known as Idiopathic Intracranial Hypertension (IIH).

Side Effects

  • Migraines
  • Increasingly common headaches
  • Double-vision (diplopia)
  • Sensitivity to light (photophobia)
  • Blurry vision
  • Temporary blindness
  • Enlargement of the blind spot
  • Blindness
  • Tinnitus (ringing in the ears)
  • Nausea
  • And more

Does Ocella Cause BIH?

Experts do not know if Ocella causes BIH because no one knows what causes the disease. However, there are a growing number of case reports, studies, and lawsuits describing dozens of cases of BIH among women on birth control.

Bayer, the manufacturer of Ocella, is facing several lawsuits from women who used Mirena (an IUD containing levonorgestrel) and were diagnosed with BIH. There are also studies dating back to the 1990s linking Norplant, a birth control implant, with over 50 cases of BIH. In recent years, case reports have also associated BIH with the use of exogenous estrogen and birth control injections.

Ocella and Secondary Intracranial Hypertension

Ocella contains drospirenone, a “fourth-generation” progestin that was associated with a three-fold increased risk of blood clots in recent studies. The FDA warned about this risk in a Drug Safety Communication published in April 2012.

Blood clots that form in arteries can potentially travel to the brain and cause a stroke. They can also obstruct the flow of cerebrospinal fluid and cause secondary intracranial hypertension, a disorder that has identical symptoms and complications as BIH. Both condition occur when abnormally high levels of cerebrospinal fluid increase pressure inside the skull.