What can be found in the literature concerning backache as a common side effect of medroxyprogester

Fråga: What can be found in the literature concerning backache as a common side effect of medroxyprogesterone, as stated in the Swedish catalogue of approved medical products (FASS)?

A 30-year-old woman has been treated with goserelin (Zoladex) for endometriosis during a long period. Significantly lower bone density was found and Zoladex was withdrawn. Medroxyprogesterone (Depo-Provera) treatment was started and the woman experienced backpain 2-3 days after her first injection.

Sammanfattning: There are a few reports on backpain following medroxyprogesterone treatment avaliable in the literature. No clear time relationsship to the drug treatment can be drawn from the published studies and according to the manufacturer backpain have been reported during long-time treatment and it is unclear why it is mentioned as a common side effect in FASS.

Svar: There are some reports availiable in the literature concerning backpain as a possible adverse drug effect following medroxyprogesterone depot injections (1,2,3,4).

Twelve percent of 53 depot medroxyprogesterone users reported backache as a side effect during a 30-month prospective study in adolecents (1). Backache has also been reported in an efficacy and drug safety study among 165 saudiarabian women, although the number of subjects with backache was not stated (2). In a study with depot medroxyprogesterone 6 out of 98 menopausal women reported backpain (3). One of 156 adolecents who discountinued depot medroxyprogesterone treatment reported backpain as the reason for discountinuation (4).

In the files of SADRAC (The Swedish Adverse Drug Reactions advisory Committee) there is one report of backpain following medroxyprogesterone injection (5). In the adverse drug reactions database from WHO there are several reports of musculo-skeletal system disorders although no reports of backpain (6).

It has been demonstrated that medroxyprogesterone reduces bone density although no signs of osteoporosis have been noted. Bone density returns to normal after cessation (7,8).

According to the manufacturer backpain have been seen mainly in elderly patients or in young patients who have used medroxyprogesteron for a long time (9). 1 Matson SC, Henderson KA, McGrath GJ. Physical findings and symptoms of depot medroxyprogesterone acetate use in adolescent females. J Pediatr Adolesc Gynecol 1997;10:18-23. 2 Sobande AA, Al-Bar HM, Archibong EI, Sadek AA. Efficacy and acceptability of depo-medroxyprogesterone acetate injection. As a method of contraception in Saudi Arabia. Saudi Med J 2000;21:348-51. 3 Harrison RF, Magill P, Kilminster SG. Impact of a new formulation of low-dose micronised medroxyprogesterone and 17-beta estradiol on lipid profiles in menopausal women. Clin Drug Invest 1998;16:93-9. 4 Lim SW, Rieder J, Coupey SM, Bijur PE. Depot medroxyprogesterone acetate use in inner-city, minority adolescents. Arch Pediatr Adolesc Med 1999;153:1068-72.

5 Swedis (The Swedish Drug Information System) (cited 2003-02-17)
6 Vigibase: WHO:s adverse drug reactions database (cited 2003-03-03)
7 Cundy T, Reid IR. Bone loss and depot medroxyprogesterone. Am J Obstet Gynecol 1997;176:1116-7.

8 Kaunitz AM. Ínjectable depot medroxyprogesterone acetate contraception: an update for US clinicians. Int J Fertil Womens Med 1998;43:73-83. 9 Personal communication, Arvid Nordenhem, Pharmacia Upjohn, 2003-02-26