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Gianvi Idiopathic Intracranial Hypertension Lawsuit

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Hormones in the once-daily birth control pill Gianvi may increase a woman’s risk of high pressure inside the skull, a condition known as Idiopathic Intracranial Hypertension. Serious complications include chronic headaches and incurable blindness.

Overview

Gianvi is a birth control pill that is the generic form of Yaz, which means they contain the same active ingredients, but have different manufacturers. The hormones in Gianvi include a combination of estrogen (ethinyl estradiol) and progestin (dropsirenone). Gianvi has been approved by the FDA since 2010.

Idiopathic Intracranial Hypertension

Idiopathic Intracranial Hypertension (IIH) occurs when there is too much cerebrospinal fluid. Normally, this fluid acts like a cushion between the brain and skull. Too much fluid puts pressure on the brain and causes headaches. Over time, it can damage the optic nerve and cause vision complications.

What is the problem?

The National Institute of Health warns that birth control pills are a possible risk-factor for IIH.

These warnings were published after 56 cases of IIH were linked to Norplant, a progestin-only contraceptive implant, in a study published by the New England Journal of Medicine in 1995.

In the last two decades, other types of birth control have been linked to IIH, including progestin-only injections (Depo-Provera) and exogenous estrogen. However, it is unknown if Gianvi or any contraceptives cause IIH — the term “idiopathic” means “of unknown cause.”

IIH and Blood Clots

Gianvi contains drospirenone, a “fourth-generation” progestin that was marketed as superior to older progestins. The popularity of drospirenone plummeted after studies found it was up to three times more likely to cause a blood clot compared to older progestins, like levonorgestrel, but no better at preventing pregnancy.

Blood clots in the brain are a risk-factor for secondary intracranial hypertension. This complication occurs when the blood clot physically obstructs the flow of cerebrospinal fluid into the brain.

Symptoms of IIH

  • Headache (usually every day)
  • Migraines
  • Double-vision
  • Temporary blurry vision or blindness (30 seconds or less)
  • Ringing in the ears (tinnitus)
  • Enlargement of the blind spot
  • Progressive loss of vision
  • Blindness

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