DRAP’s Action on Medroxyprogesterone Acetate in Response to Meningioma Concerns and US Lawsuits

Amid the ongoing lawsuits in the US against Pfizer for allegedly failing to disclose the risk of meningioma on the label of Depo-Provera® (medroxyprogesterone acetate), filed by numerous women who developed the condition after receiving the injection, attention has also turned to DRAP’s action on medroxyprogesterone acetate in Pakistan regarding its safety evaluation and regulatory response.

First look at what steps does other countries has taken in this regard:

• On 7 October, 2024, MHRA-UK (Medicines and Healthcare products Regulatory Agency- United Kingdom) received Direct Healthcare Professional Communication from Pfizer regarding Medroxyprogesterone acetate’s risk of meningioma and measures to minimise this risk stating “There is a small increased risk of developing meningioma with high doses of medroxyprogesterone acetate (all injectable and ≥100 mg oral formulations), primarily after prolonged use (several years).” As a result of this MHRA updated the labels of Depo-provera® and other brands of medroxyprogesterone acetate (MPA) with the meningioma warning.
• European union (EU) drug also updated their labels and mention meningioma under the “special warnings and precautions for use” section and recommends patients to speak with their doctors before using Depo-Provera® if they have a history of meningioma.

• Likewise, in October 2024, Health Canada updated the Canadian product monographs for MPA to include the risk of meningioma.
• The association between the risk of meningioma and high dose of medroxyprogesterone acetate is nothing new to human knowledge. Since the medical and scientific communities are well-aware of the huge number of progesterone receptors on meningioma cells, compare to estrogen receptors alongside the researchers have been aware of the relationship between progesterone-inhibiting agents and the growth rate of meningioma.