Recent studies reveal that two different drugs pose health risks to babies if taken by pregnant women.
A study published in JAMA Internal Medicine linked the narcolepsy drugs modafinil (Provigil) and armodafinil (Nuvigil) with major congenital malformations in babies born to women who used the medication while pregnant.
Among 102 live births among women treated with the drugs, 13% had babies with congenital malformations — far more than the 3% in the general population. Four of the babies were diagnosed with congenital torticollis, a rare condition in which the neck muscles contract, causing the head to twist to one side. Two were diagnosed with hypospadias, a rare condition in which the opening of the penis is on the underside rather than the tip. Three of the babies — about 3% — were born with congenital heart defects, more than the 1% usually seen in the general population.
Provigil and Nuvigil are used to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea, narcolepsy, or shift work disorders. Provigil is also used to treat fatigue associated with multiple sclerosis and other diseases.
The Food and Drug Administration (FDA) also warned consumers in a Drug Safety Communication that the labeling for nonsteroidal anti-inflammatory drugs (NSAIDs) has been updated to warn that if used by women around 20 weeks or later in their pregnancy, the drugs may be connected to rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid and the potential for pregnancy-related complications.
NSAIDs include both over-the-counter medications and prescription medicines such as ibuprofen, naproxen, diclofenac, and celecoxib. These recommendations do not apply to the use of low-dose aspirin (81 mg).
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” said Patrizia Cavazzoni, M.D., acting director of FDA’s Center for Drug Evaluation and Research. “To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
While Beasley Allen is not currently taking cases related to these drugs, we keep an eye on pharmaceutical prescriptions as well as over-the-counter drugs that may present an emerging risk to consumers. Our website has more information about cases involving medications we are currently handling.