Why the FDA Is Warning Pregnant Ladies To not Use Over-the-Counter Ache Relievers
By C. Michael White, University of Connecticut
The Food and Drug Administration warned both health professionals and women on October 15, 2020 not to use nonsteroidal anti-inflammatory drugs (NSAIDs) after 20 weeks of pregnancy.
It does this after the FDA adds its post-market surveillance data to information contained in medical journals. Consumers spent $ 4.3 billion on more than 760 million bottles of NSAID in 2019. These include those with the brand names Motrin, Advil, Aleve, Ecotrin, and Bayer Aspirin, as well as generic versions with the names Ibuprofen, Naproxen, and Aspirin.
Those numbers add to the millions of prescriptions written for pain relievers containing NSAIDs or NSAID / opioid combination products written for each year. All of this makes the warning a significant step, especially given the fact that pregnant women are often in pain that these drugs could relieve.
I am a pharmacist and cardiovascular pharmacologist specializing in preventing or reducing drug-induced diseases. A successful pregnancy is vital to a child’s health. Hence, it is important that pregnant women are aware of this newly discovered danger.
What is the problem?
Doctors and pharmacists have known for some time that NSAIDs affect kidney function in adults and can cause permanent damage to some people’s kidneys. Higher dose NSAID therapy, longer-term treatment and use in pre-existing kidney dysfunction are particularly dangerous for adults. The FDA now believes that this kidney risk extends to the fetus when the mother uses NSAIDs.
The fetus is surrounded by a protective amniotic sac that is filled with fluid. This fluid is made by the mother until the 20th week, after which the fetus’s kidneys make up a large part of the protective fluid. The FDA is aware of dozens of cases where doctors have found low and potentially dangerous amniotic fluid levels in mothers taking NSAIDs. In many of these cases, when the mother stopped taking the NSAID, the amniotic fluid levels returned to normal, but decreased again when the NSAID was restarted. Some of these mothers have seen low levels of amniotic fluid after only two days of using NSAIDs. However, other pregnant women took several weeks to detect low amniotic fluid levels.
In five cases, the FDA is aware of newborns who died of kidney failure shortly after birth. While this is only a small number of cases overall, the FDA believes that there are likely many other cases where an NSAID-induced decrease in amniotic fluid levels is not detected because both patients and doctors are unaware of the risk.
What should pregnant women do?
The FDA recommends that health professionals limit prescribing or recommending over-the-counter NSAIDs to women between 20 and 30 weeks of gestation, and avoid them altogether after 30 weeks if possible. If NSAID treatment is required, they should use the lowest effective dose for the shortest possible duration. Healthcare professionals should consider ultrasound monitoring of the amniotic fluid if treatment with NSAIDs lasts longer than 48 hours, and discontinue the NSAID if the amniotic fluid levels decrease.
The best thing a pregnant woman considering an over-the-counter NSAID for pain can do is to discuss this with her obstetrician first. Your obstetrician may recommend acetaminophen (Tylenol) as an alternative. Even then, however, there is some preliminary evidence that higher dose or longer therapy with paracetamol during pregnancy is linked to attention deficit disorder or autism during the child’s development.
Pharmacists are a wonderful resource to help patients determine which over-the-counter products contain acetaminophen or NSAIDs. This can be difficult at times as they are found in some over-the-counter cold and flu products and some sleeping pills in addition to regular pain relievers.
What about non-drug options?
Using dietary supplements for pain relief can be risky as the FDA does not guarantee the quality of manufacture and the products may contain heavy metals, bacteria, or mold. Dietary supplements are simply not as regulated as medications for reasons of safety and effectiveness. Furthermore, the lack of safety data for supplements does not mean that there are no problems, just that the risks are unknown.
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Other non-drug therapies for pain include hot packs, stretching exercises, massage therapy, visualization therapy, and other techniques. Even if these non-drug techniques do not eliminate the pain, they can reduce the dose of pain reliever or the length of therapy required. Pregnant women can try some of these options and see what works for them.
C. Michael White, distinguished professor and director of the Department of Pharmaceutical Practice at the University of Connecticut
This article is republished by The Conversation under a Creative Commons license. Read the original article.