Safety information for the use of isotretinoin
Isotretinoin is a highly effective vitamin A analogue that has been used since the early 1980s to treat severe, therapy-resistant forms of acne. When isotretinoin is taken during pregnancy, the risk of severe congenital malformations or spontaneous abortion is comparable to that after exposure to thalidomide. Isotretinoin is therefore absolutely contraindicated in pregnancy and may be prescribed or dispensed to women of childbearing age only if all conditions of a pregnancy prevention program are met.
Situation in Austria
The following medicinal products are approved in Austria:
- Ciscumed 5 mg - capsules
- Ciscutan 5 mg - capsules
- Ciscutan 10 mg - capsules
- Ciscutan 20 mg - capsules
- Ciscutan 30 mg - capsules
- Ciscutan 40 mg - capsules
- Isotretinoin "ratiopharm" 10 mg - capsules
- Isotretinoin "ratiopharm" 20 mg - capsules
BASG recommendations
Recommendations for prescribers:
- Preparations containing isotretinoin should only be prescribed by a physician who is familiar with the use of systemic retinoids and knows their risks.
- Isotretinoin is indicated only for severe acne, such as acne nodularis, acne conglobata, or acne at risk of permanent scarring that has not responded to adequate standard therapy with systemic antibiotics combined with topical preparations.
- The treatment period should be kept as short as possible and the dose should be adjusted individually.
- The patient must be informed of the teratogenic risk verbally and in writing and confirm her understanding in writing.
- The patient must be fully informed orally and in writing about contraceptive methods and their possible failure (e.g., when using St. John's wort preparations, antibiotics, etc., or when experiencing diarrhea, vomiting, etc.).
- To exclude pregnancy at the start of therapy, two medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/ml, carried out at intervals of four weeks, must be performed and documented. The second of the two tests will not be done until the patient has used contraception as defined in the Pregnancy Prevention Program for at least one month prior to starting therapy.
- Throughout the duration of therapy with isotretinoin, the patient must consistently use at least one, and preferably two, reliable methods of contraception (hormonal + barrier) without interruption.
- Isotretinoin prescriptions for women of childbearing age must be limited to a treatment period of 30 days and dispensing must occur no more than seven days after the prescription is written.
- Continuation of treatment beyond 30 days requires a new prescription, which must always be preceded by a physician-supervised and documented pregnancy test with a minimum sensitivity of 25 mIU/ml.
- Contraception must be continued for at least one month after the end of treatment to ensure that isotretinoin has been completely excreted. In addition, a final, physician-controlled and documented pregnancy test with a minimum sensitivity of 25 mIU/ml must be performed five weeks after the end of therapy.
- In the event of pregnancy, therapy must be discontinued immediately and the patient referred to a physician experienced in teratology.
Recommendations for patients:
- You must not give the drug to anyone, especially women, and should return any unused tablets or capsules to the pharmacy for disposal.
- You must not donate blood until one month after the end of treatment. Since isotretinoin is highly likely to pass into breast milk, isotretinoin must also not be used in nursing mothers.
- The federal agency also strongly warns against purchasing preparations containing isotretinoin from the Internet. A recently published study has shown that patients are not informed about the fertility damaging potential and the necessity of using reliable contraceptive measures.
Queries (technical): Dr. Christoph Baumgärtel, Tel.: 050555/36004 E-mail: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse@ages.at
