Depo-Provera "Black Box" Urges Limited Long-Term Use
This article was originally published in The Pink Sheet Daily
Executive Summary
Pfizer's injectable contraceptive should be used longer than two years "only if other birth control methods are inadequate," the "black box" states. Warning regarding bone loss is based on two five-year Phase IV studies in adolescents and adults.
You may also be interested in...
Depo-Provera Black Box Warning Challenged In Physician Petition
Two obstetrician/gynecologists argue there is no published clinical evidence that extended use of the injectable contraceptive is harmful; they cite a Pfizer-funded study that found Depo-Provera users already had a higher risk of bone fracture than nonusers and the risk did not increase with use of the drug.
Pfizer Depo-subQ Provera 104 Will Launch In May With Endometriosis Indication
The new formulation has greater contraceptive efficacy and less hormone than Depo-Provera, Pfizer says. Labeling carries "black box" warnings on loss of bone mineral density; Pfizer notes that, in clinical trials, depo-subQ provera 104 had less decrease in BMD than endometriosis-pain comparator Lupron Depot.
Pfizer Depo-subQ Provera 104 Will Launch In May With Endometriosis Indication
The new formulation has greater contraceptive efficacy and less hormone than Depo-Provera, Pfizer says. Labeling carries "black box" warnings on loss of bone mineral density; Pfizer notes that, in clinical trials, depo-subQ provera 104 had less decrease in BMD than endometriosis-pain comparator Lupron Depot.