Health Canada Notice: ALERTEC (Modafinil) linked to risks of Congenital Anomalies

Health Canada recently announced that the drug ALERTEC has been associated with cases of major fetal congenital malformations including congenital cardiac anomalies. ALERTEC produced by TEVA Canada Innovation is now contraindicated in women who are pregnant or may become pregnant.

ALERTEC (modafinil 100 mg tablets) is used as a symptomatic treatment of excessive sleepiness in adult patients with narcolepsy, obstructive sleep apnea, and shift work disorder.

Health Canada is advising all health care professionals to discuss with their patients of reproductive potential that are treated with or to be treated with ALERTEC of:

• the potential risks associated with the drug to a fetus during pregnancy;
• the need for a negative pregnancy test within week before starting treatment with ALERTEC;
• the need to use effective contraception during therapy with ALERTEC and for two months after stopping ALERTEC;
• and the possible reduced effectiveness of steroidal contraceptives when using ALERTEC.

Health Canada and TEVA Canada Innovation updated the Canadian Product Monograph to reflect this new safety information.

Read Health Canada’s full advisory here.