Can Roaccutan (isotretinoin) cause amenorrhea?/nThe question concerns an 18-year-old woman with acn

Fråga: Can Roaccutan (isotretinoin) cause amenorrhea? The question concerns an 18-year-old woman with acne who has been treated with Roaccutan (isotretinoin) for the last six months. During this time she was amenorrheic. No concomitant drugs.

Sammanfattning: Documentation concerning menstrual disorders under isotretinoin treatment is sparse. There are case reports suggesting that isotretinoin is associated with amenorrhea. However, since oral contraceptives are often used concomitantly, a causal relationship between drug use and amenorrhea/ menstrual irregularities is difficult to establish.

Svar: Information concerning menstrual irregularities under isotretinoin treatment is scarce. A letter in The British Journal of Dermatology describes a case where a 14-year-old girl with severe nodulo-cystic acne developed amenorrhea during isotretinoin treatment. After 10 weeks the treatment was discontinued as the girl admitted that she had not menstruated since starting isotretinoin therapy, although she had had regular menses every 4 weeks for the preceding 3 years. She had no oral contraceptive treatment and her menstruation recurred about 10 days after stopping isotretinoin and was regular thereafter (1). Six of 53 female patients treated by Bruno et al reported abnormal menses during a 4-month course of isotretinoin treatment, the symptoms generally being of a "late" or "skipped" menstrual period. One of these patients had amenorrhea for two cycles. The report discloses no specific information on the use of oral contraceptives although women were advised to use "effective contraception techniques" during treatment (2).

There are no reports in the Swedish Adverse Drug Reaction Advisory Committee database concerning amenorrhea as an adverse effect following isotretinoin treatment.

In WHO´s adverse reaction database, Intdis, there are 148 reports of amenorrhea associated with isotretinoin. However, these reports are not evaluated due to the differences of the reporting systems in the participating countries (3).

There is no information in Drugline or pharmacological handbooks on amenorrhea or any other menstrual disorder as an adverse effect of isotretinoin.

We recommend this case be reported to SADRAC (The Swedish Adverse Drug Reaction Advisory Committee).