The alert, posted on the FDA’s website Oct. 15, warns that the use of NSAIDs at 20 weeks or later in pregnancy may cause kidney dysfunction in developing infants. This condition could result in a lack of amniotic fluid surrounding the baby, leading to additional complications affecting a baby’s limb and lung development.
“Although this safety concern is well known among certain medical specialties, we wanted to communicate our recommendations more widely to educate other health care professionals and pregnant women,” the FDA said in a drug safety communication.
The agency initially stated that the issue affects all OTC and prescription NSAIDs. On Oct. 16, the FDA updated the statement to say that the warning did not apply to NSAIDs administered directly to the eye.
In light of the warning, the FDA is requiring several changes to NSAID product labeling.
For prescription NSAIDs, the agency is requiring changes to the prescribing information to describe the risk of kidney problems in unborn children that result in low amniotic fluid.
For OTC NSAIDs intended for use in adults, the FDA will update Drug Facts labels with additional information.
The agency also issued several recommendations for health care professionals.
“We are recommending avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy rather than the 30 weeks currently described in NSAID prescribing information,” the agency stated.
If NSAID use between 20 and 30 weeks pregnancy is deemed necessary by a health care professional, the FDA said, it should be limited to the lowest effective dose for the shortest duration.
If NSAID treatment extends beyond 48 hours, clinicians should consider ultrasound monitoring of amniotic fluid. If low amniotic fluid is evident, NSAIDs should be discontinued and follow-up care should be provided according to clinical practice.
The FDA added that the recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy.
Zita Magloire, M.D., a partner and immediate past CEO of a group practice in Cairo, Ga., who also served as chair of the Department of Obstetrics and Pediatrics at Grady General Hospital and is the current chair of the Academy’s Obstetrics Member Interest group, told AAFP News that family physicians, through their extensive training and diverse patient population, are in an optimal position to educate patients and the public on these types of warnings.
“The take-home message is that we should not prescribe or recommend over-the-counter NSAIDs to pregnant women,” Magloire said.
“I never recommend NSAIDs during any trimester because patients don’t always know how far along they are, or more specifically, how many weeks gestation,” added Magloire. “So telling patients that NSAIDs are OK before 30 weeks, or with the most recent FDA warning (of) 20 weeks, may just send mixed messages.
“Keep it simple,” Magloire said. “Pregnancy equals avoiding NSAIDs.”
Because many FPs are the primary source of health care for patients regardless of their pregnancy status, Magloire said that it’s important to counsel patients who are planning on or who may become pregnant to limit or avoid NSAID use. If those patients have a chronic condition that requires pain relief, Magloire suggested several alternatives.
“For mild occasional pain associated with common self-limiting conditions such as headaches and musculoskeletal pain, I recommend acetaminophen or topical analgesics such as lidocaine, or topicals containing menthol, methyl salicylate and capsaicin,” Magloire said.
As for nondrug regimens, Magloire recommended a number of options, such as taping, osteopathic manipulative therapy and therapeutic massage.
Consumers, patients and clinicians are advised to report adverse events or side effects related to NSAID use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Adverse events can be reported online, by phone at (800) 332-1088, or by downloading a voluntary reporting form and faxing or mailing it to the agency.