Consumer Safety Watch Warns Hormonal Birth Control May Lead to Pseudotumor Cerebri/Intracranial Hypertension

Mirena IUD and Ortho Evra have been linked to symptoms that include migraines, tinnitus (hissing, roaring, ringing or whooshing sound in the ears), vision loss, Nausea, vomiting or dizziness, loss of balance, and additional symptoms.

​There has long been a connection between certain types of hormonal birth control and serious side effects in users, and now according to Consumer Safety Watch, a consumer safety advocate organization, Bayer’s Mirena IUD birth control device and the Ortho Evra patch may be tied to a devastating condition known as pseudotumor cerebri, which causes a dangerous increase in pressure on the brain.

Symptoms of Pseudotumor Cerebri

Pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH) or simply intracranial hyptertension, is a serious medical condition characterized by increased pressure inside the skull, and symptoms of the condition mimic those of a brain tumor, despite the fact that no actual tumor is present.

The exact cause of PTC in most patients can be difficult to determine, but is most often tied to an elevated amount of cerebrospinal fluid, which surrounds the brain and spinal cord, and acts as a cushion to protect the tissues from injury. Cerebrospinal fluid is produced in the brain and is eventually absorbed into the bloodstream, but an interference in this absorption process may result in intracranial pressure from pseudotumor cerebri.

In addition to its effect on the brain, the increased intracranial pressure associated with pseudotumor cerebri can cause swelling of the optic nerve, which can lead to progressive vision loss that may become permanent in some cases. Signs and symptoms of pseudotumor cerebri may include the following:

  • Nausea, vomiting or dizziness
  • Pain in the neck, back or shoulder
  • Moderate to severe headaches
  • Blurred or dimmed vision
  • Ringing in the ears
  • Brief episodes of blindness
  • Difficulty seeing to the side
  • Seeing light flashes

According to Alan Christopher, a Consumer Advocate from Consumer Safety Watch, it is advised that women that experience these side effects get checked out for pseudotumor cerebri. In most cases the diagnosis is done by an ophthalmologist or neurologist. More information on pseudotumor cerebri diagnosis is available below:

Diagnosis of Pseudotumor Cerebri

Diagnosis involves ruling out other health problems including an actual brain tumor. A physical exam and a few tests can help identify pseudotumor cerebri and rule out other causes for pressure inside the skull. The tests include:

  • Brain imaging such as MRI or CT scans

  • A lumbar puncture (spinal tap) to confirm the elevated pressure (normal is less than 25 cm) and withdraw a sample of fluid from around the spine for testing to exclude infectious and inflammatory causes of raised pressure.

  • Exam to test eye function

PTC Side Effects Linked to Mirena IUD and Ortho Evra Patch

Studies have shown that certain medications can increase the risk of pseudotumor cerebri in users, and, as early as 1995, studies began establishing a potential connection between intracranial hypertension and birth control products containing levonorgestrel, such as Bayer’s Mirena IUD implantable birth control device. In one study published in the New England Journal of Medicine, researchers identified 56 reports of pseudotumor cerebri side effects in women who received a Mirena IUD implant.

Mirena IUD is a flexible, T-shaped device that is implanted in the uterus and prevents pregnancy by releasing the birth control hormone levonorgestrel directly into the uterus over time. Mirena was approved by the U.S. Food and Drug Administration (FDA) in 2000, and has been aggressively marketed by Bayer in the years since, as a safe and effective means of preventing pregnancy for up to five years without having to take a once-daily birth control pill. However, serious concerns have been raised recently about the potential for Mirena IUD to cause serious side effects in users, including pseudotumor cerebri.

Ortho Evra is a contraceptive skin patch containing a combination of female hormones (ethinyl estradiol and norelgestromin) that prevent ovulation (the release of an egg from an ovary).

Source: Consumer Safety Watch

About Consumer Safety Watch

Consumer Safety Watch is a consumer advocate organization that helps fight for individuals and families that have been injured as a result of negligent products, medical devices or drugs and pharmaceutical products.

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