Despite Mirena Link to Pseudotumor Cerebri, No Warnings

New York, NYMore than 18 months ago, lawyers filed a number of lawsuits alleging Mirena’s association with the onset of Pseudotumor Cerebri. And 20 years ago in Mirena clinical trials, researchers warned of a neurological risk. But Bayer has yet to include these side effects on its warning label.

Mirena Pseudotumor Cerebri (PTC) lawsuits claim that Bayer failed to adequately warn about the link between the hormone levonorgestrel - which is present in Mirena and certain birth control pills - and PTC, or Idiopathic Intracranial Hypertension (IIH), meaning “high pressure inside the skull for unknown reasons.” The lawsuits allege that levonorgestrel can elevate levels of cerebrospinal fluid in the brain, which increases pressure in the brain, similar to a tumor.

How could Bayer not know about Mirena and PTC? Besides its own clinical trial results, where 7.7 percent of women reported headaches and migraine, birth controls using levonorgestrel such as Norplant and Jadelle have long contained PTC and IIH warnings in their labeling. Researchers in The New England Journal of Medicine in 1995 reported in a letter to the editor the link between levonorgestrel and intracranial hypertension.

(Progestin is a synthetic hormone, which can be used alone (as in the “mini pill”) or combined with estrogen, another hormone. Levonorgestrel is a second-generation progestin and is the most widely prescribed contraceptive progestin worldwide. Fourth-generation birth control pills, such as Yasmin and Yaz, contain the progestin drospirenone.)

As of August 2014, only nine Mirena PTC/IIH lawsuits have been filed, but this could be the tip of the iceberg. For instance, Mirena complaints associated with IUD migration and organ perforation started with a few complaints - as do most drug and medical device complaints. Now that women are aware of these Mirena side effects, more than 3,000 lawsuits have been filed, many of which are grouped into multidistrict litigation (MDL).

Given only nine of these suits so far, the The U.S. Judicial Panel on Multidistrict Litigation rejected the plaintiffs’ centralization bid suing Bayer over the neurological conditions allegedly caused by its Mirena. The panel said that there are too few suits and parties involved to warrant a consolidation. This decision, however, does not stop anyone from filing an individual claim against Bayer. The Mirena manufacturer and drug giant should have known that levonorgestrel can lead to serious neurological risks before it sought FDA approval. In fact, it should never have gotten that far.