While European Union (EU) and United Kingdom (UK) Drug Labels Have Warned About Meningioma for Many Years
(Posted by Tom Lamb at Drug Injury Watch)
Drug injury lawsuits that involve the contraceptive injection Depo-Provera being linked to brain tumors in some women have been filed against the responsible pharmaceutical companies over the past several months. The basis for these legal cases is that the current US Depo-Provera drug label (version "Revised: 7/2024") does not include any warning about intracranial meningioma.
We touched upon this in our October 16, 2024 article, "Side Effects of Birth Control: Brain Tumors Related to Depo-Provera Contraceptive Injections". However, in that earlier article, we did not report that the Depo-Provera drug label used in the European Union (EU) and the United Kingdom (UK) has warned about meningioma for many years.
Today we will examine this critical drug safety issue using some of the allegations found in various Complaints filed in courts around the country on behalf of women diagnosed with intracranial meningioma who are seeking legal compensation from the responsible pharmaceutical companies.
Essentially, these Depo-Provera drug injury lawsuits are based on the general contention that the pharmaceutical companies knew that Depo-Provera was unreasonably unsafe and unfit for use due to the "product defect" of an increased risk of intracranial meningioma associated with Depo-Provera, but failed to disclose and warn about meningioma to the regulatory agencies, the medical community, and women who received Depo-Provera injections -- at least here in the US.
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Here are some of the relevant allegations found in the Complaints filed for these Depo-Provera drug injury lawsuits:
- To date, the US Depo-Provera drug label does not mention the increased risk to patients of developing intracranial meningiomas, even though the European Union (EU) and the United Kingdom (UK) drug labels list meningioma under the “special warnings and precautions for use” section and advise patients to speak with their doctors before using Depo-Provera if they have a history of meningioma.
- Moreover, the Canadian drug label for Depo-Provera has listed “meningioma” among its “Post-Market Adverse Drug Reactions” since at least 2015.
- Several scientific studies have established that progesterone, its synthetic analog progestin, and Depo-Provera in particular, cause or substantially contribute to the development of intracranial meningioma, a type of brain tumor.
- The association between progesterone and meningioma has been known or knowable for decades, particularly for sophisticated pharmaceutical corporations like Defendants engaging in FDA-required post-market surveillance of their products for potential safety issues. That duty includes an obligation to keep current with emerging relevant literature and where appropriate, perform their own long-term studies and follow-up research.
- Since 1983 the medical and scientific communities have been aware of the high number of progesterone receptors on meningioma cells, especially relative to estrogen receptors.
- And since 1989 researchers have been aware of the relationship between progesterone-inhibiting agents and the growth rate of meningioma.
- Numerous studies published in the decades since have presented similar findings on the negative correlation between progesterone-inhibiting agents and meningioma.
- Defendant Pfizer has changed the Depo-Provera drug label in the EU and UK and potentially in other countries. Specifically, the EU drug label currently contains the following: "Meningiomas have been reported following long-term administration of progestogens, including medroxyprogesterone acetate. Depo-Provera should be discontinued if a meningioma is diagnosed. Caution is advised when recommending Depo-Provera to patients with a history of meningioma.”
As these allegations suggest, a primary focus of the US legal cases will be why the Depo-Provera drug label warnings in the US do not include the increased risk of intracranial meningioma that is included in the European Union (EU) and United Kingdom (UK) drug labels for Depo-Provera.
We are investigating Depo-Provera drug injury lawsuits for women who have been diagnosed with intracranial meningioma and are seeking legal compensation from the responsible pharmaceutical companies. We point out that these Depo-Provera cases will not be filed against the women's doctors who prescribed the Depo-Provera injections due to the failure to disclose and warn about meningioma here in the US.
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