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Physicians For Life - Abstinence, Abortion, Birth Control Depo Provera Linked to Bone Density Loss (2004) DEPO-PROVERA LABELED:LINKED TO BONE DENSITY LOSS The U.S. Food and Drug Administration(FDA) has issued a "black box warning" -- the strongest possible FDAwarning issued -- to the labeling of the Depo-Provera drug, noting thatextended use of this injectabel contraceptive can cause "significantbone density loss." [Right to Life, www.cincinnatirighttolife.org.
Cincinnati Right to Life, April 2008] Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection The Food and Drug Administration (FDA) announced today that a "blackbox" warning, highlighting prolonged use may result in the loss of bonedensity, will be added to the labeling of Depo-Provera ContraceptiveInjection, an established injectable drug approved for use in women toprevent pregnancy.
Although Depo-Provera Contraceptive Injection has been used for decadesfor birth control throughout the world and remains a safe and effectivecontraceptive, FDA and Pfizer, the drug's manufacturer, are taking thisaction to ensure that physicians and patients have access to thisimportant information.
The black box warning for Depo-Provera highlights that prolonged use of the drug may result in significant loss of bonedensity, and that the loss is greater the longer the drug is administered. This bone density loss may not be completely reversible after discontinuation of the drug. Thus the warning states that a woman should only use Depo-Provera Contraceptive Injection as a long-term birth controlmethod (for example, longer than two years) if other birth control methods are inadequate for her.
Physicians For Life - Abstinence, Abortion, Birth Control Black box warnings are designed to highlight special problems, particularly those that are serious, and to give health careprofessionals a clear understanding of a potential medical complication associated with a drug. Black box warnings provide physicians with important insights as to how to prescribe a drug that may be associated withserious side effects in a way that maximizes its benefits and minimizes its risks.
The addition of the black box warning came as a result of the drug manufacturer's and FDA's analysis of data thatclarified the drug's long-term effects on bone density.
In addition to the black box warning on the labeling, the drug's manufacturer will issue a "Dear Health Care Practitioner"letter regarding the effect of long-term treatment on bone mineral density to prescribers likely to prescribe the drug, andwill incorporate the new information in the patient information sheet distributed with the drug. [November 17, 2004 - TalkPaper - FDA] . that a "black box" warning highlighting prolonged use may result in the loss of bone density, will be added to the labeling of Depo-Provera Contraceptive .
www.fda.gov/cder/previous_news2004.htm - 01-03-2008 - * FDA announces that a "black box" warning highlighting prolonged use may result in the loss of bone density, will beadded to the labeling of Depo-Provera Contraceptive Injection, an established injectable drug approved for use in womento prevent pregnancy. MedWatch Safety Info.
Depo-Provera (medroxyprogesterone acetate injectable suspension) FDA and Pfizer notified healthcare professionals of the addition of a BOXED WARNING along with revisions to theWARNINGS, INDICATIONS AND USAGE, PRECAUTIONS and POSTMARKETING EXPERIENCE sections of theprescribing information to include information on the loss of significant bone mineral density. Physicians For Life - Abstinence, Abortion, Birth Control Depo-Provera Contraceptive Injection is indicated only for the prevention of pregnancy in women of child-bearingpotential. Bone loss is greater with increasing duration of use and may not be completely reversible. Depo-ProveraContraceptive should be used as a long-term birth control method (eg, longer than 2 years) only if other birth controlmethods are inadequate.
[November 18, 2004 - Dear Healthcare Professional Letter - Pfizer] Adobe Acrobat [pdf] file [November 18, 2004 - Dear Healthcare Organization Leader Letter - Pfizer] Adobe Acrobat [pdf] file [November, 2004 - Label - Pfizer] Adobe Acrobat [pdf] file -http://www.fda.gov/medwatch/SAFETY/2004/DepoProvera_Label.pdf [http://www.fda.gov/cder/previous_news2004.htm]

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