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The FDA recently announced in a drug safety advisory that it is requiring changes to the labeling of nonsteroidal anti-inflammatory drugs (NSAIDs).
These changes include adding new labels that can lead to rare but serious kidney problems in unborn babies if a woman takes the drug at ≥20 weeks of pregnancy, which can lead to low amniotic levels and pregnancy-related complications.
NSAIDs include ibuprofen, naproxen, diclofenac and celecoxib.
have been taking these drugs for decades to treat pain and fever caused by various diseases.
NSAIDs have both prescription and over-the-counter drugs (OTCs).
these drugs are used to stop the production of certain inflammatory chemicals in the body.
aspirin is also an NSAID, however these recommendations do not apply to the use of low-dose aspirin (81 mg).
low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the guidance of a healthcare professional.
it's important for women to understand the benefits and risks of taking drugs during pregnancy," said Dr. Patrizia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research.
this, the agency is using its regulatory authority to inform women and their health care providers of the risks of using NSAIDs around 20 weeks of pregnancy or more.
" as noted in the Drug Safety Advisory, the warning was issued after the FDA reviewed the medical literature and the low levels of amniotic water or kidney problems associated with the use of NSAID in unborn children reported to the agency during pregnancy.
about 20 weeks into pregnancy, the fetus' kidneys begin to produce most of the amniota, so fetal kidney problems can lead to low amniophic levels.
low levels of amniotic water, a condition known as too little amniotic water, may be detected days or weeks after taking the drug, but it may be detected as soon as 2 days after the start of regular use of NSAID.
if a pregnant woman stops taking NSAID, the condition usually disappears.
For NSAID prescription drugs, the FDA requires changes to prescription information to describe the risk of kidney problems in unborn fetuses, leading to amniotaid deficiency, and recommends limiting the use of NSAID between 20 and 30 weeks of pregnancy.
warnings about avoiding NSAID after 30 weeks of pregnancy are included in the prescription information, as taking these medications during this time can cause heart problems in the unborn child.
if the healthcare provider deems it necessary to use NSAID between 20 and 30 weeks of pregnancy, it should be limited to the lowest effective dose and the shortest possible time.
OTC NSAID manufacturer will make a similar update to the Drug Fact Labels.
while some health care providers treating pregnant women are generally aware of the risk of low levels of amniotress, the FDA is spreading this message more widely to educate other health care professionals and pregnant women.
health care professionals and patients should report side effects of USSAID use to the FDA's MedWatch program.
source: FDA Warns that Using a Type of Pain and Fever in Second Half of Pregnancy Can To Complications Original title: FDA Safety Advisory: Pregnant Women Taking Common Nonsteroidal Anti-inflammatory Drugs such as ibuprofen or Cause Severe Kidney Problems in the Fetus!