A case for concern?
Gartland, A.
Nursing Times 79(18): 10-11
1983
ISSN/ISBN: 0954-7762 PMID: 6222288 Document Number: 205874
The risks and benefits of Depo-Provera, the controversial contraceptive, are examined. In April 1983 Upjohn Limited, the American manufacturers of Depo-Provera, presented evidence about its product before a government appointed panel at a hearing held in public. This was the 1st time this had happened in Britain. The panel also read submissions from the Coordinating Group on Depo-Provera, a group of women who argue that a longterm license should not be granted. A 150 mg dose of Depo-Provera, a synthetic progestogen (medroxyprogesterone), injected into the muscle is slowly released into the body over a 3-month period and inhibits ovulation by suppressing the pituitary hormones which cause release of a mature egg. It was initially licensed in the UK in 1973 for treatment of endometriosis. In 1978 it was approved for short term contraception in limited circumstances. At present it is only recommended for women who have been immunized against German measles to provide contraceptive cover during the active period of the virus and for those whose partners have had a vasectomy but whose sperm count is not yet negative. In 1981 it was licensed for use as a treatment for endometrial, renal, and breast cancer. The UK Committee on Safety of Medicines (CSM) now recommends that Depo-Provera should be used in the longterm but only as a last resort when all other contraceptive methods are unsatisfactory. It also wanted 4 warnings to be entered on the data sheet to which doctors refer: that Depo-Provera could be secreted in breast milk; that doctors should ensure their patients are not already pregnant; that tumors have developed in monkeys given 50 times the human dose; and that a few cases of breast cancer have been reported but no causal relationship with Depo-Provera has been established. The licensing authority considered that the potential risk associated with Depo-Provera use appeared to outweigh the benefits, and it rejected the CSM's advice. Kenneth Clarke was particularly concerned that the drug might be given to women without their informed consent, a concern raised by the women's group. Upjohn maintains that Depo-Provera is a safe, efficient contraceptive which has had no known death attributed to it and that its failure rate is lower than with other methods. It is recognized, in Upjohn data, that Depo-Provera frequently disrupts the menstrual cycle and that there may be irregular bleeding or spotting. After 1 year of taking the drug many women suffer amenorrhea, and a woman may not regain her fertility for up to 18 months after stopping the injections. Upjohn argues that excessive bleeding is rare, but the women's group submits numerous experiences from women who have suffered heavy bleeding long after the effects of the drug would be expected to have worn off.