THE BABY BEAT – February 23, 2011 D. Gary Benfield, M.D. Taking nonprescription drugs in pregnancy DEAR DR. BENFIELD: Last week I learned that I’m pregnant. I sometimes take
Prilosec OTC for heartburn and Unisom Sleep Gels to help me sleep. Can you tell me if
these nonprescription medicines are safe to take during pregnancy? A.S. DEAR A.S.: Congratulations! Before discussing your question of fetal safety when
using these drugs during pregnancy, here’s a useful tip, starting with Prilosec OTC. This
drug is a very effective treatment for heartburn. It has one active ingredient, omeprazole,
which treats the symptoms of heartburn. If you go to Walmart’s web site and look up
Prilosec OTC, you’ll find it priced at $10.86 for a pack of 14 tablets, or 78 cents per tablet.
(Each tablet contains 20 mg of omeprazole.) On the other hand, WalMart’s in-house
brand is Equate. If you look up “Equate Omaprazole Delayed Release Acid Reducer 20
mg Tablets,” they are priced at $19.97 for a pack of 42 tablets, or 48 cents per tablet. This
is 62 percent cheaper than Prilosec OTC. Both drugs contain the same amount of the
active ingredient, omeprazole, and are equally effective.
The same idea applies to Unisom Sleep Gels. Unisom contains one active ingredient,
doxylamine succinate. A pack of 32 Unisom Sleep Gels sells for $7.78, or 24 cents per
gel. Meanwhile, Walmart’s Equate brand of doxylamine succinate sells for $4.00 for 32
tablets, or 12 cents per tablet. This is half the price. Both versions of the same active
ingredient are equally effective yet one sells for half the price of the other. So my tip is
this: There is no need to buy the name brand of an OTC drug if the in-house brand of the
drug is also available. They are both equally effective, but the in-house brand will almost
always be significantly cheaper. This not only applies to Walmart’s Equate in-house brand
but to Target, Rite Aid, CVS and Walgreen’s, to name a few others. Simply ask the
pharmacist for help. Now let’s move on to your question.
Taking nonprescription drugs in pregnancy
As we said earlier, the active ingredient in Prilosec OTC is omeprazole, which has a
pregnancy risk category of C. This means omeprazole is likely safe but should only be
used in pregnancy when clearly needed. It’s reassuring that a recent study published in the
New England Journal of Medicine found that omeprazole does not pose an increased risk
of fetal harm when taken during the first trimester of pregnancy.
Regarding Unisom, its active ingredient is doxylamine succinate, which has a pregnancy
risk category of A. This means it is safe to use during pregnancy.
In summary, both Prilosec OTC and Unisom Sleep Gels, or the in-house brands of each,
are probably safe to take during pregnancy. As always, pregnant women should consult
their healthcare provider before taking any drug.
A further thought: Last week, the FDA notified healthcare professionals that injectable
terbutaline should not be used in pregnant women to prevent or treat preterm labor beyond
48 to 72 hours in either the hospital or outpatient setting because of the potential for
serious maternal heart problems and death. In addition, oral terbutaline should not be used
to prevent or treat preterm labor because it has not been shown to be effective and has
Background: Terbutaline is approved by the FDA to prevent and treat bronchospasm
(narrowing of the airways) associated with asthma, bronchitis, and emphysema. The drug
is sometimes used off-label (an unapproved use) for acute obstetric uses, including preterm
labor. Terbutaline has also been used off-label over longer periods of time in an attempt to
Recommendation: Based on the FDA’s review, it has concluded that the risk of serious
adverse events outweighs any potential benefit to pregnant women receiving prolonged
Taking nonprescription drugs in pregnancy
treatment with terbutaline injection (beyond 48 to 72 hours), or acute or prolonged
treatment with oral terbutaline. The FDA is requiring the addition of a new Boxed
Warning to terbutaline drug labels to warn healthcare professionals about these risks.
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MANY YEARS ago when I was a young man, I happened to spend asummer with my friends, the Wints, in Oxford. Guy Wint was on the staff of Theobserver and was away in London most of the day. His wife, Freda, had convertedto Buddhism and was also out most of the time meeting fellow Buddhists. Theirson, Ben, was at a boarding school. For company, I had the Wints' three-year-old daughter, Allegra. In