其 他 安 全 警 示
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| Canada: ALERTEC (modafinil) and the risk of congenital anomalies (English only) |
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Health Canada announces that ALERTEC (modafinil) has been associated with cases of major fetal congenital malformations, including congenital cardiac anomalies when used during pregnancy.
ALERTEC (modafinil 100 mg tablets) is indicated in Canada for the symptomatic treatment of excessive sleepiness in adult patients with narcolepsy, obstructive sleep apnea (OSA) and shift work disorder (SWD - a circadian rhythm sleep disorder).
After developmental toxicity was observed in animal studies, the Food and Drug Administration in the United States requested the initiation of the Nuvigil/Provigil Pregnancy Registry to characterize the pregnancy and fetal outcomes associated with Provigil (modafinil) and Nuvigil (armodafinil, the R-enantiomer of modafinil; not marketed in Canada) exposure during pregnancy. In Feb 2019, Teva Canada Innovation informed Health Canada of the results of the 2018 annual report of the Nuvigil/Provigil Pregnancy Registry. This report documented cases of spontaneous abortion and of major congenital anomalies, including cardiac congenital anomalies. The frequency of major congenital anomalies (17.3%) and cardiac anomalies (4%) associated with the exposure to modafinil and/or armodafinil was above the frequency observed in the general population (3% and 1%, respectively). There have also been post-marketing reports of congenital malformations and of low fetal growth, as well as cases of babies who failed to thrive (poor physical development).
Healthcare professionals are advised:
- ALERTEC is contraindicated in women who are pregnant, or who may become pregnant.
- Discuss with all female patients treated or to be treated with ALERTEC the potential risks associated with ALERTEC to a fetus during pregnancy.
- Ensure all female patients of reproductive potential have a negative pregnancy test within a week before starting treatment with ALERTEC.
- Instruct all female patients of reproductive potential that they must use effective contraception during therapy with ALERTEC, and for two months after discontinuation of ALERTEC treatment.
- Inform female patients that ALERTEC may reduce the effectiveness of steroidal contraceptives and that alternative or concomitant methods of contraception, other than steroidal, are required during the ALERTEC treatment, and for two months after discontinuation of ALERTEC.
Health Canada, in collaboration with Teva Canada Innovation, updated the Canadian Product Monograph (CPM) for ALERTEC to reflect this new safety information. Health Canada will work with the manufacturers of generic versions of modafinil to update their respective CPMs.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../70201a-eng.php
In Hong Kong, there is no registered pharmaceutical product containing modafinil or armodafinil.
Ends/Friday, Jun 21, 2019
Issued at HKT 15:00
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