Risk of congenital malformations with modafinil
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Risk of congenital malformations with modafinil There appears to be an increased risk of congenital malformations after in utero exposure to modafinil, according to a recent Drug Safety Update from the MHRA, and patients are recommended to use effective contraception during treatment with modafinil. Modafinil is used to treat adults with narcolepsy. A European review, which considered interim US registry data and spontaneous reports, concluded that there was a possible risk of congenital malformations in the offspring of women who received modafinil during pregnancy. The prevalence of major congenital malformations was 14.75% in the US data, compared with 3% in the general population, including a higher prevalence of cardiac abnormalities (4.92% vs 1%). Other malformations included hypospadias and orofacial clefts. In addition, animal studies revealed reproductive toxicity. The product information for modafinil was updated, and a letter was sent to prescribers. Following evaluation of the European review and additional safety data, the MHRA supports the suggestion of a increased risk of major congenital malformations. Healthcare providers should inform women of childbearing potential about the teratogenicity risk, and encourage effective contraception during treatment and for two months after stopping modafinil. Any suspected adverse reactions should be reported to the agency. Medicines and Healthcare products Regulatory Agency. Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy. Drug Safety Update : 16 803518022 Nov 2020. Available from: URL: https://www.gov.uk/drug-safety-update/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy
0114-9954/20/1832-0001/$14.95 Adis © 2020 Springer Nature Switzerland AG. All rights reserved
Reactions 28 Nov 2020 No. 1832
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