asked the Secretary of State for Social Services (1) if, during the period in which Depo Provera was licensed for use in maintaining pregnancy, any adverse reactions were reported by general practitioners or hospital doctors to the Committee on Safety of Medicine following the use of the drug in such circumstances; and if he will make a statement;(2) if he will produce a table showing the reports of suspected adverse reactions to Depo Provera detailing the main types of reaction and the date of reports since the drug was first licensed for use in Great Britain in 1968.
The following table indicates the number of reports of suspected adverse reactions received by the Committee on Safety of Medicines. The figures should, however, be interpreted with caution since an association of two events does not necessarily imply a causal relationship. None of the reports listed relates to cases in which Depo Provera was used in the treatment of habitual or threatened abortion.
| REPORTS OF SUSPECTED ADVERSE REACTIONS TO DEPO-PROVERA 1963—MARCH 1980 | ||||||||||||||
Type of reaction suspected
| 1963–72 | 1973
| 1974
| 1975
| 1976
| 1977
| 1978
| 1979
| January to March 1980
| Total
| ||||
| Skin disorder | … | … | … | … | — | 1 | — | 1 | 1 | 1 | 1 | — | 5 | |
| Central nervous system | … | … | … | … | — | — | — | 1 | — | 1 | 1 | — | 3 | |
| Psychiatric disorders | … | … | … | … | — | — | — | — | 1 | 1 | 2 | — | 4 | |
| Weight gain | … | … | … | … | — | — | — | — | — | — | — | 2 | — | 2 |
| Goitre | … | … | … | … | — | — | — | — | — | — | 1 | — | — | 1 |
| Vascular disorders | … | … | … | … | — | — | — | — | — | 3 | — | 5 | — | 8 |
| Urinary disorders | … | … | … | … | — | — | — | — | — | 1 | — | — | — | 1 |
| Menstrual disorders | … | … | … | … | — | — | — | — | — | — | 1 | 4 | — | 5 |
| Reproductive disorders | … | … | … | … | — | — | — | — | 1 | — | 1 | — | — | 2 |
| Peri-natal obesity | … | … | … | … | — | — | — | — | — | — | 1 | — | — | 1 |
| Neoplasms | … | … | … | … | — | — | — | — | — | — | 1 | — | — | 1 |
| General disorders | … | … | … | … | — | — | — | — | — | 2 | 1 | — | — | 3 |
| Total | … | … | … | … | — | 1 | — | — | 3 | 8 | 9 | 15 | — | 36 |
Depo-Provera has been available in the United Kingdom since 1963 for the treatment of endometriosis and since 1974 has been licensed in addition for use as a short-term contraceptive, in specified circumstances. It was also licensed for the treatment of habitual and threatened abortion until 1978.