A recent Alertec health alert by Health Canada has given rise to a wave of fear in users of the stimulant drugs modafinil. According to the alert, modafinil can have potentially deadly complications for the children of pregnant women.
A Summary of The Alertec Health Alert
Alertec is the Canadian brand name version of the drug modafinil. The version of modafinil sold in the United States is known as Provigil. Modafinil is typically used to treat narcolepsy, sleep apnea, and other sleep disorders. The Alertec health alert has called attention to the fact that in addition to treating these disorders, Alertec has been connected to a number of fetal complications.
According to the Alertec health alert, when used during pregnancy, Alertec has been connected to cases of major fetal congenital malformations, including congenital cardiac anomalies. These complications could potentially come at the cost of the fetal child’s life. Additionally, the Alertec health alert mentions that cases of spontaneous abortions have also been reported.
Starting in February 2019, TEVA Canada Innovation informed Health Canada that certain results of the 2018 annual report from Nuvigil/Provigil Pregnancy Registry documented cases of spontaneous abortion and of major congenital anomalies. The study reports that these anomalies in fetal development occurred between four and six times more often in users of Alertec than in the control group.
According to the Alertec health alert, patients taking Alertec, or other forms of modafinil, had a 17.3% occurrence of congenital defects (compared to a control of approximately 3%), and cardiac anomaly occurrence of 4% (compared to an approximate control of 1%). Additionally, the Alertec health alert included post-marketing reports of congenital malformations, low fetal growth, and infants who featured poor physical development and “struggled to thrive.”
As a result of the Alertec health alert, Health Canada has issued new guidelines:
- Alertec is no longer suggested for women who are pregnant or may become pregnant.
- New information is included in the Canadian Product Monograph (CPM) for Alertec under the Contraindications, Warnings and Precautions, and Patient Medication sections.
- Healthcare professionals are now suggested to discuss certain topics with all female patients of reproductive potential to be treated with Alertec including the possible reduced effectiveness of steroidal birth control while using Alertec.
- A negative pregnancy test is required one week before beginning Alertec
- Effective contraception must be used during treatment with Alertec as well as two months after stopping Alertec
- Patients using steroidal contraceptives should use alternative or additional methods of contraception while using Alertec treatment and for an additional two months after stopping Alertec
With these new regulations and the awareness spread by the Alertec health alert, consumers will hopefully be more protected moving forward.
How The Alertec Health Alert Affects Americans Seeking Damages
Although the Alertec health alert may frighten modafinil users in the U.S. there is not a significant risk of these symptoms repeating in America. According to United States Food and Drug Administration (FDA) safety reports, the American brand version of modafinil, Provigil, was flagged as a pediatric risk to pregnant women and children in 2007 and had an additional labeling change in 2010. Since that time Provigil and modafinil have been classified as category C drug. A class C drug is to be treated as potentially harmful to pregnant women but there have not been sufficient human trials to demonstrate that risk irrefutably. The FDA is also following two studies related to the effects of Provigil on pregnant women.
If you or a loved one have been prescribed Provigil, modafinil, or any other category C drug while pregnant and have suffered fetal complications or spontaneous abortion, there may be a case for medical malpractice and compensation may be available to you. When pursuing this compensation, be sure to choose the best legal representation for you: Parker Waichman LLP.
At Parker Waichman LLP, experienced trial lawyers are prepared to pursue your case to its utmost conclusion in order to get you the compensation you deserve. Don’t wait, contact Parker Waichman today for a free consultation.