Today, I want to write to you about acetaminophen in pregnancy, a discussion that has been brought to the forefront by recent product recalls of Tylenol® and combination products containing Tylenol. This recall has baffled and confused my own patients, and many others, regarding the safety of swallowing this simple pain reliever. We should be especially careful now because we are still in the middle of a seasonal flu season including swine flu, which is especially risky for pregnant women.
The news is reporting contamination of a compound called 2,4,6-tribromoanisole. This seems to be the the result of a chemical produced when certain fungicides (mold inhibitors) are used to treat wooden pallets used to transfer products in the manufacturing plants. The health effects of ingesting and inhaling these contaminated products are unknown, but for the safety of both the mother and the fetus, pregnant women should be cautious and check the website www.mcneilproductrecall.com for specific batch lot numbers. We all need to be certain that contaminated capsules and gel tabs are NOT ingested in pregnancy.
The information below only pertains to Tylenol in its pure form, that which has NO evidence of any chemical contamination.
What should one do if pregnant and need relief of flu symptoms, fever, headaches, migraines, muscle aches and the like?
Acetaminophen is one of the most popular drugs used in America, and abroad, for reducing fever and for controlling pain. Vitamins are perhaps the only other prescription medication that are used more frequently by pregnant women. Acetaminophen is sold individually or in combination with decongestants and antihistamines in most common cold preparations and it is taken much more frequently than aspirin by pregnant women. Acetaminophen is also one of the most commonly overdosed drugs in pregnancy. Normal recommended dosage is 1,000 mg every 4 hours but acetaminophen in excessive doses can lead to liver toxicity and possibly fetal death because it is metabolized in the liver and readily crosses the placenta to reach the fetus.
Data on acetaminophen safety has been sparse until a recent published study, January 2010 in Obstetrics and Gynecology by Feldkamp, which collected data from the National Birth Defects Prevention Study. Telephone interviews were conducted with mothers of children with birth defects from 10 centers in the United States who delivered between January 1997 and December 2004 and used acetaminophen anytime from the first day of the last menstrual period through the first 12 weeks of pregnancy. Control groups were used for comparison. The study had limitations since it relied on accuracy of maternal memory regarding whether or not acetaminophen was used in the first trimester. The study also relied on maternal memory regarding the number of pills and dosage taken, which also could have a bearing on the the drug’s effects on the fetus.
Use of acetaminophen in the first trimester was found to be very common—averaging about 46%. Most importantly, the use of a single agent, acetaminophen, was NOT associated with any increased risk of birth defects. In fact, it was found that acetaminophen may DECREASE the risk of specific malformations that commonly occur in the first trimester when there is febrile (fever) illness in the mother. In particular, there was a decreased incidence of anencephaly, craniorachischisis, encephalocele, anotia or microtia, cleft lip with or without palate and gastroschisis. Other studies have shown that acetaminophen does not have any impact on fetal growth or preterm delivery.
Summary: Use of acetaminophen may have beneficial effects during a febrile (fever) illness when used as a single agent in the first trimester of pregnancy. Never exceed the recommended dosage.
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