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Yasmin Idiopathic Intracranial Hypertension Lawsuit

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Since the 1990s, researchers have reported a link between certain types of birth control and idiopathic intracranial hypertension (IIH). Although rare, this severe neurological syndrome can injure the brain and cause nerve damage in the eyes. Without treatment, it can cause blindness.

What is Yasmin?

Bayer HealthCare Pharmaceuticals manufactures Yasmin, a birth control pill that contains 3-mg of dropsirenone (progestin) and 0.03-mg of ethinyl estradiol (estrogen). These hormones are more than 99% effective at preventing pregnancy when women use Yasmin as directed.

Yasmin and Idiopathic Intracranial Hypertension (IIH)

The term Idiopathic Intracranial Hypertension (IIH) means “high pressure inside the skull due to unknown cause.” Although many risk-factors have been identified, no one knows if Yasmin causes IIH. Instead, experts warn that birth control pills are possible risk-factors.

The concern is based on a number of studies published in the last few decades. In 1995, a study published in the New England Journal of Medicine found evidence linking 56 cases of IIH and optic disc edema with subdermal contraceptive implants containing levonorgestrel. IIH has also been associated with progestin-only injections and exogenous estrogen.

Yasmin and Blood Clots

Blood clots are more likely to occur in women on Yasmin, according to a warning issued by the FDA in 2012. When blood clots form in arteries, they can travel to the brain (cerebral venous thromboembolism) and cause life-threatening complications. One complication, “secondary intracranial hypertension,” occurs when the blood clot physically obstructs the flow of cerebrospinal fluid.

What is IIH?

Idiopathic Intracranial Hypertension (IIH) occurs when there is too much cerebrospinal fluid. Normally, this fluid surrounds and cushions the brain from impacts. IIH puts pressure on the brain (similar to a growing brain tumor). Over time, it can cause severe damage to the optic nerve and permanent blindness.

IIH may cause the following symptoms:

  • Migraine headache
  • Constant headaches
  • Tinnitus (ringing in the ears)
  • Sensitivity to light
  • Blurry vision (may last 30 seconds and resolve)
  • Double-vision (diplopia)
  • Papilledema (swelling of the optic disc)
  • Progressive enlargement of blind spot
  • Blindness
  • And more

FDA Warning Letter

Yasmin was the focus of a Warning Letter (PDF) issued by the FDA in 2003. According to the FDA, certain ads for Yasmin were “misleading” and violated federal law:

“[The ad] minimizes the important risk information that distinguishes Yasmin from other combination oral contraceptives. As a result, the TV ad raises significant public health and safety concerns.”

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