Pfizer says

Pfizer says it couldn't have warned about tumor risk in Depo-Provera lawsuits

CHICAGO, Aug 25 (Reuters) - Pfizer has urged a Florida federal judge to dismiss lawsuits claiming its birth control shot Depo-Provera (medroxyprogesterone acetate) can cause users to develop a type of brain tumor, saying regulators barred the company from including a warning about the tumors on the drug’s label.

Ø Plaintiffs claim Depo-Provera causes brain-impacting tumors

Ø FDA rejected Pfizer's request to add tumor warning, company says

Ø Pfizer wants pilot cases dismissed

The New York-based pharmaceutical company told U.S. District Judge M. Casey Rodgers in Pensacola in a Friday filing that claims the company failed to warn consumers and physicians about the risk of meningiomas associated with the drug were preempted by the U.S. Food and Drug Administration’s rejection of that warning before the litigation began.

The tumors are often benign but can compress brain tissue and require surgery, the plantiffs said in the court filing.

Depo-Provera is a brand-name hormonal birth control injection containing progestin that prevents pregnancy by stopping ovulation and thickening cervical mucus, making it difficult for sperm to reach an egg. A healthcare provider administers this contraceptive shot every three months (11-13 weeks) and it is a prescription-only method. The injection can also provide benefits such as lighter periods, reduced risk of anemia, and protection against endometrial cancer.

DEPO-PROVERA Sterile Aqueous Suspension contains medroxyprogesterone acetate, which is a derivative of progesterone and is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200° and 210° C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether and insoluble in water.