Pregnancy and OTC Medications

General information to consider before taking medications while pregnant

• Risks and benefits of medications should always be evaluated when deciding to use medications during pregnancy.
• There may be times during pregnancy where you must decide whether or not you really need to take a medication for a simple symptom that you may be able to tolerate (i.e. stuffy nose, simple headache) or whether or not you need a medication for a more serious matter that requires chronic medical management (i.e. diabetes, asthma etc.).  
• If possible, try to avoid all use of medications during the 1st trimester since this is the time the fetus is developing and is at most risk from developing medication-related defects.
• No medication is considered to be totally safe despite the pregnancy risk rating below.
• Medications are rarely tested in pregnant women before they come to market because it is considered unethical to expose a pregnant woman to a drug with unknown effects.
• Most information for detecting birth defects is collected after the medication has already hit the markets.  However, only after a large number of defects have be seen can an association be made between a particular medication causing birth defects. (Note: In the general population there is a 3-5% risk of having a child with a birth defect or mental retardation.)
• The Food and Drug Administration (FDA) has developed letter categories for all prescription medications to help explain risks of taking medications during pregnancy.  However, OTC drugs do not have classification on their label, although many OTC drugs were once prescription medications (where they were classified in such a manner).
• OTC medications do not have a letter classification like below, but on the label it contains a statement regarding the safety and possible risks of taking the OTC medication during pregnancy.
• If you are not sure, please contact your physician or pharmacist before taking any OTC medication since they have appropriate references and databases to help verify the risks (and if necessary provide safe alternatives).

FDA's Pregnancy Letter Categories For Prescription Medications and Interpretation

• A    Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal    abnormalities to the fetus in any trimester of pregnancy.

• B    Animal studies have revealed no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women or animals which have shown an adverse effect. However, adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

• C    Animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in pregnant women (or studies in women and in animals are unavailable).Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

• D    Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

• X    Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

Cough and Cold Medicines During Pregnancy

• It is important to remember that most cold symptoms are self-limiting.  Thus, it is recommended to try non-drug treatments first (i.e. hydration, saline nasal sprays, use of humidifiers etc.) to relieve symptoms especially during the first trimester.
• Drugs that are commonly utilized for a cough and cold may include the following classes of drugs: analgesics/antipyretics (to relieve pain and fever), antihistamines (to relieve runny nose and watery eyes), cough suppressants, expectorants (to help drain mucus from lungs) and decongestants (to relieve nasal congestion). 

Safest OTC Analgesics and Antipyretics During Pregnancy

• Acetaminophen or Paracetamol (Tylenol, Anacin Aspirin Free) is pregnancy risk B and is considered the safest analgesic/antipyretics and drug of choice during pregnancy. Safe for short term use. (However, I personally do not agree due to new reports about possible risks for acetoaminophen/paracetamol causing autism in newborns and in young children-Please see my latest post on Tylenol. Do not exceed more than 3 grams/day. Other analgesic/antipyretics (i.e. Aspirin, NSAIDS (non-steroidal anti-inflammatory drugs like ibuprofen(Advil, Motrin), naproxen (Aleve)) have more risk to the fetus and I recommend avoiding their use during pregnancy altogether.
• Natural alternative: Suggest eating fresh ginger root, taking ginger root capsules (not extract) up to 1500mg/day or drinking ginger tea.  The ginger can help reduce pain, swelling and fever.

Safest OTC Antihistamines During Pregnancy

• Doxylamine is preganancy risk category A (very safe), but unfortunately is usually found in combination products that have other ingredients like dextromethorphan or alcohol which should(i.e. avoided during pregnancy (i.e.Nyquil).  You can find this as a singular ingredient sold as an OTC sleeping aid (i.e. Unisom Sleep Tabs).  Dosage: Recommend taking 12.5mg every 6 hours if needed (half of a 25mg Unisom sleep tab).  Note: It can cause severe drowsiness.
• Chlorpheniramine (Chlor-Trimenton) is Pregnancy risk category B and considered a good choice if an antihistamine is needed during pregnancy. Do not exceed a dose of 24mg/day.  Normal doses may include 4mg every 6 hours.  Controlled release and sustained release formulations are available 8mg and 12mg tablets. May cause drowsiness.
• Diphenhydramine (Benadryl) Pregnancy risk category B.  May use during the first semester. Normal dose: 25mg every 6 hours.  May cause drowsiness.
• Clemastine (Tavist-Allergy) Pregnancy risk category B. If possible, avoid combination products (i.e. Tavist-D) with the decongestant  phenylpropanolamine or pseudophedrine (Pregnancy risk category C). Normal dose 1mg clemastine tablet every 12 hours if needed. May cause drowsiness.
• Cetirizine (Zyrtec) is a Pregnancy risk category B.  Note: This is a second generation antihistamine that has less potential to cause drowsiness. It may be used as a safe alternative to Doxylamine, Chlorpheniramine or Diphenhydramine except during first trimester.  Normal dose: 5-10mg/day.
• Loratidine (Claritin) is preganancy risk category B.  My also be used as an alternative to Doxylamine, Chlorpheniramine or Diphenhydramine except during first trimester since it causes much less drowsiness. If possible, avoid Claritin-D since it contains pseudophedrine unless absolutely necessary since it is a risk category C. However, if a decongestant is necessary, then pseudophedrine is considered the oral decongestant of choice during pregnancy except during the first trimester.  Normal dose: One 10mg tablet per day.

Safest OTC Decongestants During Pregnancy

• Oxymetazoline (Dristan Nasal Spray, Afrin Nasal Spray) Pregnancy risk category C. Limit use to 3 days.  Only use if necessary.  Considered decongestant of choice during pregnancy. Normal dose: 2-3 sprays per nostril ever 12 hours if needed.
• Pseudophedrine (Sudafed) Pregnancy risk category C. Considered the oral decongestant of choice during pregnancy.  Avoid use during the first trimester. Normal dose: 30mg every 6 hours if needed. Only use if necessary during pregnancy, otherwise avoid use altogether since it can impair placental blood flow.
• Natural Alternative: Use plain saline nasal spray or use saline water in neti pot. Also you may eat onions.

Safest OTC Expectorants and Cough Suppressants

• Guaifenesin (Robitussin, Humibid) Pregnancy risk category C. Avoid use during first trimester due to some risk for child developing inguinal hernia http://www.babycenter.com/0_hernias_1176787.bc with use. Probably safe if use after first trimester. Not that effective at clearing secretions. Normal dose: 200-400mg every 4 hours.  Max dose. 2.4 grams.  Recommend to use sparingly.
• Dextromethorphan (Delsym) Pregnancy risk category C. Use only if necessary to relieve cough to avoid possible risk to fetus. Doses vary based on formulations.  Normal dose for Delsym: 30mg every 12 hours if needed. Don't use more than 120mg/day. Found in many combination products (i.e. Robitussin DM).
• Natural alternatives: Use Honey and Ginger Tea to relieve cough and drink plenty of fluids to help clear secretions.

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Sources for this post include:

http://www.foxnews.com/health/2011/05/26/women-using-medications-pregnancy/
http://www.otispregnancy.org/
http://www.otispregnancy.org/otis-fact-sheets-s13037#1
http://women.webmd.com/pharmacist-11/pregnancy-medicine
http://www.webmd.com/baby/guide/taking-medicine-during-pregnancy
http://depts.washington.edu/druginfo/Formulary/Pregnancy.pdf
http://www.womenshealth.gov/publications/our-publications/fact-sheet/pregnancy-medicines.cfm
Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002.
http://www.perinatology.com/index.html
Pharmacists Letter Database 2012.
http://www.webmd.com/pain-management/news/20110728/new-dosing-labels-for-extra-strength-tylenol
http://www.babycenter.com/0_chart-over-the-counter-medications-during-pregnancy_1486462.bc
http://www.motherisk.org/women/pregnancyResources.jsp
http://www.americanpregnancy.org/pregnancyhealth/naturalherbsvitamins.html
http://www.drweil.com/drw/u/QAA400749/Avoid-Ginger-While-Pregnant.html
http://www.livestrong.com/article/315819-is-ginger-root-safe-during-pregnancy/
http://www.acupuncturetoday.com/mpacms/at/article.php?id=27849
http://oregon.providence.org/ptkattachments/recommendedresource/medications%20that%20are%20safe%20during%20pregnancy[1].pdf
http://findarticles.com/p/articles/mi_m0689/is_8_56/ai_n27355452/
http://www.obfocus.com/reference/Formulary/Drugs%20in%20Pregnancy/Dextromethorphan.htm
http://www.obfocus.com/high-risk/meds1.htm
http://www.livestrong.com/article/516421-a-cough-suppressant-for-pregnant-women/