FDA Issues A New Warning On NSAID Use In Pregnancy

Dangers of NSAID’s during pregnancy

Healthcare professionals have long accepted that by the third trimester, pregnant women should avoid taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for the aches and pains commonly associated with the final days of gestation. The initial concerns involved the risk of potential heart damage to babies exposed to NSAIDs after the thirtieth week of pregnancy. Concern over the serious health risk led OB/GYNs to instruct their newly pregnant patients on the dangers involved, even going as far as listing it on patient pamphlets distributed at their practices.

This month, the FDA issued a new warning on NSAID use in pregnancy. After reviewing cases of mothers with dangerously low amniotic fluid levels, safety concerns led the FDA to require labeling changes for drugs in this class. Pregnant women are now strongly warned to steer clear of over-the-counter pain relievers, including Motrin, Celebrex, Advil, and Aleve after the twentieth week of pregnancy and until delivery.

NSAIDs work by blocking the production of prostaglandins, which in turn, dials down the inflammation in the body. Millions of Americans reach for these easily available, over-the-counter drugs without so much as a second thought.  The reason is simple:  this class of drugs works wonders in treating headaches, fever, congestion, and even body aches associated with the common cold and flu.

Unfortunately, the very process of regulating blood flow that halts headache pain so well can leave an unborn baby at risk for structural damage and serious kidney complications. When pregnant women take NSAIDs, the umbilical cord’s blood vessels constrict, and blood flow from mother to baby is compromised.

After the twentieth week of pregnancy, the reduced blood flow brought about by taking NSAIDs puts the unborn baby at risk of kidney damage, and in worst-case scenarios, death. The reduced maternal blood flow leads to the kidneys not working optimally, thus decreasing the baby’s urine production. Appropriate urine output is critical to the safety and growth of an unborn baby. After all, the all-important and very protective amniotic fluid surrounding the baby is made up of the baby’s urine.

So when NSAIDs negatively impact the blood flow from mother to baby, the kidneys cannot produce enough urine, leaving the amniotic fluid to dip to dangerously low levels. Oligohydramnios, a serious condition where there is too little amniotic fluid for the baby to thrive and grow in utero, has been documented in pregnant women on a regimen of NSAIDs.

Some expectant mothers were negatively impacted within days of starting on an NSAID regimen. Fortunately, as reported in The Rheumatologist, oligohydramnios can be reversed seventy-two hours to six days after the mother stops taking the drug. However, when the condition goes unchecked, babies can be born with neonatal renal dysfunction. The FDA reviewed several case reports and series where babies exposed to NSAIDs in utero experienced kidney problems in their first days following birth.

Along with the new warning, the FDA asks that patients and healthcare professionals report any adverse reactions believed to be caused by NSAID use in pregnancy to their Medwatch program.