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Depo-Provera Contraceptive Injective (CI) is a long-acting progestin form of birth control manufactured by the Upjohn Company, a division of pharmaceutical giant, Pfizer. It was developed in the 1960s and had been approved for birth control in many other countries except the United States. The Upjohn Company first submitted it for approval in the United States in the 1970s. At that time, animal studies raised questions about its potential to cause breast cancer.
It wasn't until 1992 that the FDA approved Depo-Provera for U.S. use. According to the FDA memo, it said that worldwide studies have since found the overall risk of cancer, including breast cancer in humans, to be minimal, if any.
Women's health groups in other countries have also highlighted previously identified risks to women's health such as an increased risk of breast, uterine, and cervical cancers. Though previously mentioned and a concern, they are now just being addressed.
In a July 6, 1991 issue of the British Medical Journal, a study found that the bone density of 30 women who had been using Depo-Provera for at least five years was less than the bone density of other women of similar ages.
If the British medical community knew that in 1991, why was that not taken into consideration in 1992 when the FDA approved Depo-Provera for sale? And why did it take the U.S. regulated FDA to get Pfizer until 2004 to issue a warning label to Depo-Provera?
Previously, the FDA felt that a woman considering Depo-Provera needed to discuss the possibility of bone thinning with her doctor and the risk of osteoporosis is just part of the equation. However, the FDA did eventually require Upjohn to conduct additional research on the effects of Depo-Provera on bone density.
The problem is that while other countries' medical communities had concerns and were conducting studies, the FDA felt Depo-Provera risks was just part of the equation.
On November 18, 2004, Pfizer Inc. sent health care professionals a letter updating them about safety information regarding Depo-Provera. As a result, Pfizer has new clinical data regarding the use of Depo-Provera Contraceptive Injection and its associated effect on bone mineral density (BMD).
In the first quarter of 2005, Pfizer reported a net income of $301 million. As of 2005, Depo-Provera has been used internationally for almost 25 years and in the United States for 13 years. In 2004, Pfizer issued a warning label.
Side Effects Associated with Depo-Provera:
- Osteoporosis
- Hip and Joint Fractures
- Blood Clots
- Breast Cancer
- Loss of Bone Density
- Loss of Height or Shrinking
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