PTC/IIH Symptoms Include Migraines With Blurred Or Double Vision, Temporary Blindness, Other Visual Problems, And Wooshing Or Ringing In The Ear

(Posted by Tom Lamb at DrugInjuryWatch.com)

Mirena is an intrauterine system (IUS) from Bayer Healthcare Pharmaceuticals, Inc. that releases 20 μg/day of levonorgestrel.  Basically, the Mirena releases levonorgestrel, a synthetic progestogen, directly into the uterus for birth control.  The FDA approved Mirena in December 2000 and it is used by more than 2 million women in the US.

The Prescribing Information for Mirena (accessed 5/30/14) does not warn about neurological conditions such as pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH) or benign intracranial hypertension. In fact, the Mirena Prescribing Information (also known as the package insert or label) makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH.

Pseudotumor cerebri or idiopathic intracranial hypertension (PTC/IIH) is a non-stroke neurological condition that develops in the skull when a person’s cerebrospinal fluid becomes elevated, causing increased pressure.

PTC/IIH symptoms include:

• severe migraines or migraine-like headaches
  with blurred vision
• diplopia (double vision), temporary blindness, blind spots, or other visual
  deficiencies
• papilledema, or optic disc swelling, due to
  increased intracranial pressure
• a “whooshing” or ringing in the ear, clinically called tinnitus

When patients present with symptoms of PTC or IIH they often first undergo an MRI, CT scan, and/or other diagnostic radiology tests to rule out an actual tumor or blood clot in the brain.  This differential diagnosis is warranted because PTC derives its name from the fact that the condition acts like a tumor but it is not actually a tumor.

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It is important to note, here, that because the current Bayer label for Mirena does not have any warnings of PTC or IIH, once a woman’s doctor rules out transient cerebral ischemia or stroke as a cause of the above symptoms her doctor does not know to advise her to remove Mirena.  And with the Mirena left in place, it causes or contributes to the development and/or progression of PTC/IIH.

Unfortunately, the failure to timely diagnose and treat PTC or IIH may lead to permanent vision loss and even blindness.

Ultimately, a lumbar puncture, or spinal tap, is how pseudotumor cerebri or idiopathic intracranial hypertension is frequently diagnosed.

Notably, there is currently no treatment to reverse permanent injury to the optic nerves that is caused by increased intracranial pressure. Because of this, once the PTC/IIH is correctly diagnosed, treatment going forward is focused only on halting visual loss that has already occurred.

Although PTC or IIH is considered reversible in some patients, it may take years before normal pressure is maintained. In other patients, PTC/IIH may be irreversible, or the condition recur throughout the patient’s lifetime.

In severe cases of PTC/IIH a lumbarperitoneal shunt (“LP shunt”) or a ventriculo-peritoneal shunt (“VP shunt”) may be used to help drain cerebrospinal fluid from the lower back or from the skull.
 
Because of Bayer’s failure to warn in the Mirena package insert or label about the risk of developing pseudotumor cerebri or idiopathic intracranial hypertension (PTC/IIH) due to the release of levonorgestrel by the Mirena, women have filed products liability lawsuits against the drug company.

We are currently reviewing possible Mirena drug injury cases involving these non-stroke neurological conditions PTC and IIH at our firm.

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