Published September 21, 2009 OTC MEDICATIONS Treating Common Problems in the Pregnant Patient W. Steven Pray, PhD, DPh Bernhardt Professor, Nonprescription Products and Devices College of Pharmacy Southwestern Oklahoma State University Weatherford, Oklahoma US Pharm. 2009;34(9):12-15. Community pharmacists field many questions regarding self-care in the pregnant patient. It is always prudent to check the label directions on each nonprescription product to see whether it carries a warning against unsupervised use in patients who are pregnant or nursing. If the warning is present, the safest course of action is to suggest that the patient contact her physician. Some argue that pharmacists are competent to make recommendations for the pregnant patient. However, this practice is fraught with danger, as any harm to the fetus or mother could be construed to have been caused by the pharmacist’s recommendation. For these reasons, the pharmacist should have a more detailed understanding of nonprescription therapy for several common pregnancy-related conditions. Constipation Pregnant patients often ask about nonprescription products for constipation. There are several reasons why the pregnant patient experiences constipation to a greater degree than those who are not pregnant.1 First, the patient who is pregnant may not be as physically active as she was prior to her pregnancy.2 Since physical activity helps facilitate the propulsive activity of the colon, being sedentary contributes to colonic inertia. Secondly, the expanding bulk of the gravid uterus can cause colonic compression, hampering the normal intestinal propulsion. Thirdly, prenatal vitamins contain calcium and iron, both of which can cause or aggravate constipation.3 In choosing a bowel-normalizing product for the pregnant patient, it should be noted that some products do not carry a pregnancy warning, such as psyllium (e.g., Konsyl, Metamucil), methylcellulose (e.g., Citrucel), and calcium polycarbophil (e.g., FiberCon).4 The pharmacist should always double-check the label to be sure, but in general, bulk laxatives are safe in pregnancy. Other laxative categories, such as salines (e.g., Citroma, magnesium citrate), stimulants (e.g., Correctol, Carter’s Pills, ex-lax), and stool softeners (e.g., Colace, Dulcolax Stool Softener), usually carry the pregnancy warning and should not be recommended unless a physician has advised their purchase.4 Mineral oil should always be prohibited during pregnancy, as its use can cause hemorrhagic disease of the newborn due to impaired absorption of vitamin K.4 Similarly, castor oil is absolutely prohibited during pregnancy. Castor oil is often recommended by well-meaning friends or relatives, as well as by irresponsible Web sites to hasten delivery of an overdue baby, but this dangerous use can increase the risk of meconium aspiration and can cause the death of the mother and the child.4 It must be strongly advised against whenever the pharmacist is able to do so. Melasma Many pregnant women notice melasma gravidarum, an unusual darkening of the facial skin.5-7 The condition is one of many pigmentary disorders that produce hypermelanosis, but chloasma gravidarum or the “mask of pregnancy,” occurs in conjunction with pregnancy.8 Melasma occurs in 50% to 70% of females during pregnancy.5 Women with darker skin are more likely to experience melasma. The discolored areas are defined as macules, which may grow together as the pregnancy progresses. The macules are most often found on sun-exposed areas such as the cheeks, upper lip, chin, and forehead. Fluctuations in progesterone during pregnancy are thought to be a major contributor to melasma, since nonpregnant females taking progesterone also develop the condition. Melasma is self-limited and usually fades gradually during the postpartum period.5 However, the time period until full resolution is variable, and some women never fully return to their prepregnancy appearance. For this reason, females are best advised to prevent the problem. Prevention centers around the observation that protection from the sun can help reduce the risk of melasma. Thus, pregnant females should heed all advice regarding sun avoidance to target areas. This includes appropriate dress when outside, such as use of broad-brimmed hats that reduce ultraviolet exposure to the entire face. She should also consider using cosmetics and lip balms containing sunscreens with a high sun protection factor (SPF). Once melasma has developed, the patient may wish to reduce the extent and degree of the discoloration. Topical tretinoin may help, but its use is accompanied by irritation, erythema, and exfoliation.9 If the patient wishes to use a nonprescription product, only hydroquinone is proven safe and effective in depigmenting melasma lesions. Common trade names include Porcelana and Esoterica. The patient must be cautioned to read and heed all labels on hydroquinone products prior to purchase and/or use. In particular, patients must be cautioned not to use the product more frequently or for a longer period than suggested. Overuse can lead to a condition known as exogenous (acquired) ochronosis, in which the product darkens the skin rather than lightening it.10,11 The darkening manifests as a gray-brown or blue-black discoloration, and the changes may be irreversible, even upon discontinuation of hydroquinone application. The patient may misunderstand that the product is causing the problem and voluntarily increase the frequency of use, worsening the problem. It is commonly seen in black women living in South Africa.12 The FDA was sufficiently concerned to issue a proposed rule about these “skin bleaching” products in the Federal Register in 2006.12 The agency expressed concern about exogenous ochronosis and also explored the potential of these products to cause cancer. There was evidence of carcinogenicity, in that hydroquinone increased the risk of renal tubular cell adenoma, mononuclear cell leukemia, and hepatocellular neoplasms, mainly adenoma.12 As a result of the more recent data, the FDA’s proposed rulemaking would establish that hydroquinone is not generally recognized as safe and effective. Until these issues are fully resolved, pharmacists might advise against use of the product in pregnant females. Nausea/Vomiting Most women experience nausea and/or vomiting during pregnancy (NVP).13,14 It may be only a minor nuisance, but it can greatly affect performance on a job, caring for children, and all aspects of quality of life. Pharmacists may be asked about treatment of these symptoms. No nonprescription product (e.g., Emetrol) is proven safe and effective for NVP. Generally, all remaining treatment options fall into three categories: home remedies, dietary supplements, and prescription products. While there are several prescription options, one study concluded that metoclopramide would be safe during pregnancy.15 Home remedies for NVP include boiled rice and lemon juice. Auricular acupressure also falls into this category. One study found that it was not effective in treating NVP, however.16 Dietary supplements touted as useful include ginger, yam root, chamomile, horse chestnut, and apple cider vinegar.17 Another unproven remedy is “Preggie Pops.” One version of this is a hard candy containing nothing more than brown rice syrup, evaporated cane juice, citric acid, flavors, and colors.18 Its claim to ease morning sickness is wholly unproven. Other versions of the same product are no better.19,20 The fallacy in recommending home remedies or dietary supplements for NVP is that none have been proven safe in pregnancy or effective in preventing or treating the condition. For this reason, pharmacists should not recommend them and should refer all patients to a physician. In an intriguing study, investigators examined 97 women with severe NVP.13 They discovered that discontinuation of iron-containing prenatal multivitamins improved symptoms for two-thirds of the subjects. While this recommendation should only be made by a physician, it does point out another possible intervention. Hemorrhoids Hemorrhoids are a common condition experienced by pregnant women. Increased venous pressure from the gravid uterus is contributory, as are venous swelling due to hormonal changes and straining during defecation.21,22 Experts advise self-help measures such as drinking 8 to 10 glasses of water daily, increasing the amount of fiber in the diet, exercising regularly, and avoiding prolonged standing or sitting. Nonprescription products containing ingredients that could pose problems in pregnancy carry a contraindication against their use.4 These include pharmacologically active ingredients such as vasoconstrictors (e.g., epinephrine, phenyl ephrine), found in Preparation H gel, cream, ointment, and suppositories. Headache Treatment of headache poses a serious problem for the pregnant patient contemplating self-care. All nonprescription non steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen, naproxen) carry a general warning against use when pregnant or nursing.4 However, the FDA also requires a special warning against use in the last trimester, as NSAIDs can affect fetal circulation and uterine contractions. Mothers may experience postpartum or antepartum bleeding disorders, as well as prolonged labor and gestation, and the fetus can suffer bleeding disorders and intraventricular hemorrhage. The patient should also be urged not to use methyl salicylate analgesic creams or ointments, as salicylate can be absorbed after application. Acetaminophen products (e.g., Tylenol) caution pregnant or breastfeeding patients to consult a health professional before use.4 Acetaminophen is a safer option during pregnancy, but the prudent pharmacist should ask the mother-to-be to consult her physician before use. Flatulence The pregnant female may ingest a high-fiber diet or psyllium products in an attempt to prevent hemorrhoids. One side effect to increasing one’s intake of fiber is flatulence. Should the pregnant patient complain about this problem, she may be counseled to use products containing simethicone (e.g., Phazyme), as this ingredient does not cause any adverse reactions. It is not absorbed, so it presents no danger to the fetus.4 GERD Many women experience heartburn and gastro esophageal reflux disease (GERD) during pregnancy. Unfortunately, nonprescription H2 blockers and proton pump inhibitors all carry a prohibition against unsupervised self-use in pregnancy. However, calcium carbonate is a safer option that can be recommended for occasional use, as long as the pregnant patient follows all labeled directions.4 When you become pregnant, you should experience a renewed sense of being cautious with everything that you eat or drink to ensure that the baby is healthy. Most women also choose wisely to stop drugs of abuse, nicotine, and alcohol. Even caffeine can be dangerous in pregnancy and should be eliminated during this time. What About Prescription Medications? When you first find out you are pregnant, you must make an immediate doctor’s appointment. Among other things, the physician will examine your drug regimen to determine whether alternative medications present less risk to the fetus. You should not stop any medications on your own. What About OTC Medications? Of course, you may choose to use nonprescription (OTC) medications to treat a wide variety of pregnancy-related problems, such as constipation, headache, nausea/vomiting (morning sickness), and hemorrhoids. You must absolutely avoid castor oil during pregnancy. Castor oil is a harsh stimulant laxative that relieves constipation by forced bowel movements. Some people also believe that it will force the uterus to deliver an overdue baby. There are numerous problems with this practice. First, the mother may not be overdue, and the baby may be born before the best time, endangering its health. Second, most of the evidence that castor oil works comes from old wives’ tales, irresponsible Web sites, and testimonials from midwives. None of these can be trusted in the same way as scientific evidence. Finally, castor oil can cause serious problems during delivery, and its use has sometimes resulted in the death of both mother and child. Castor oil taken to force a delivery has also been suspected of causing the baby to have a bowel movement before birth. This first bowel movement (meconium) is meant to be passed after birth. Should it be passed in utero, the baby can inhale it at the time of delivery, which can cause serious injury to the child or even death. Headache, nausea/ vomiting, and hemorrhoids are commonly experienced during pregnancy. Unfortunately, there are few OTC products proven safe for these conditions in the pregnant patient. Acetaminophen (e.g., Tylenol) could possibly be taken for headache with a physician’s recommendation. There are prescription drugs approved to treat nausea/vomiting, and measures such as increasing water and fiber intake may be helpful for hemorrhoids. Read the label of every nonprescription product carefully before purchase to see whether it carries a warning to consult a health professional before use. Your pharmacist can provide some assistance in choosing an appropriate medication. Should You Use Dietary Supplements? Herbals and dietary supplements have never been proven safe or effective for any use, in any group of patients. For this reason alone, using them is a dangerous gamble. Pregnant women using OTC supplements expose their fetus to unknown hazards, as these products have never been tested or approved for use in pregnancy either. Mothers have lost their babies due to herbs and dietary supplements, and babies have been born with serious medical problems due to their use. In general, the use of these products should be avoided during pregnancy unless directed by a physician. Remember, if you have any questions, Consult Your Pharmacist. REFERENCES 1. Prather CM. Pregnancy-related constipation. Curr Gastroenterol Rep. 2004;6:402-404. 2. Staying fit while pregnant. The National Women’s Health Information Center. www.womenshealth.gov/WOMAN/ newsletter/2009/05/31/. Accessed July 29, 2009. 3. Nguyen P, Thomas M, Koren G. Predictors of prenatal multivitamin adherence in pregnant women. J Clin Pharmacol. 2009;49:735-742. 4. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006. 5. Bolanca I, Bolanca Z, Kuna K, et al. Chloasma—the mask of pregnancy. Coll Antropol. 2008;32(suppl 2):138-141. 6. Moncada B, Sahagun-Sanchez LK, Torres-Alvarez B, et al. Molecular structure and concentration of melanin in the stratum corneum of patients with melasma. Photodermatol Photoimmunol Photomed. 2009;25:159-160. 7. Woolery-Lloyd H, Friedman A. Optimizing patient care with “natural” products: treatment of hyperpigmentation. J Drugs Dermatol. 2009;8(suppl):s10-s13. 8. Plensdorf S, Martinez J. Common pigmentation disorders. Am Fam Physician. 2009;79:109-116. 9. Kang HY, Valerio L, Bahadoran P, Ortonne JP. The role of topical retinoids in the treatment of pigmentary disorders: an evidence-based review. Am J Clin Dermatol. 2009;10:251-260. 10. Merola JF, Meehan S, Walters RF, Brown L. Exogenous ochronosis. Dermatol Online J. 2008;14:6. 11. Charlin R, Barcaui CB, Kac BK, et al. Hydroquinone-induced exogenous ochronosis: a report of four cases and usefulness of dermoscopy. Int J Dermatol. 2008;47:19-23. 12. Skin bleaching drug products for over-the-counter human use; proposed rule. Fed Regist. 2006;71:51146-55115. 13. Gill SK, Maltepe C, Koren G. The effectiveness of discontinuing iron-containing prenatal multivitamins on reducing the severity of nausea and vomiting of pregnancy. J Obstet Gynaecol. 2009;29:13-16. 14. Lacasse A, Rey E, Ferreira E, et al. Determinants of early medical management of nausea and vomiting of pregnancy. Birth. 2009;36:70-77. 15. Matok I, Gorodischer R, Koren G, et al. The safety of metoclopramide use in the first trimester of pregnancy. N Engl J Med. 2009;360:2528-2535. 16. Puangsricharern A, Mahasukhon S. Effectiveness of auricular acupressure in the treatment of nausea and vomiting in early pregnancy. J Med Assoc Thai. 2008;91:1633-1638. 17. Home remedies for pregnancy nausea. GrannyMed. www.grannymed.com/meds/ pregnancy-nausea.aspx. Accessed July 29, 2009. 18. Preggie Pop Drops Sour Fruit. Three Lollies Products. www.threelollies.com/store/ tek9.asp?pg=products&specific= jnrrnmo0. Accessed July 29, 2009. 19. Preggie Pop Drops Herbal. Three Lollies Products. www.threelollies.com/store/ tek9.asp?pg=products&specific= joencpd0. Accessed July 29, 2009. 20. Preggie Pop Drops–Organic. Three Lollies Products. www.threelollies.com/store/ tek9.asp?pg=products&specific= joenjrk8. Accessed July 29, 2009. 21. Staroselsky A, Nava-Ocampo AA, Vohra S, Koren G. Hemorrhoids in pregnancy. Can Fam Physician. 2008;54:189-190. 22. Pregnancy and newborn health education center. Hemorrhoids. March of Dimes. www.marchofdimes.com/pnhec/ 159_15290.asp. Accessed July 29, 2009. 23. Dugoua JJ, Perri D, Seely D, et al. Safety and efficacy of blue cohosh (Caulophyllum thalictroides) during pregnancy and lactation. Can J Pharmacol. 2008;15:e66-e73. To comment on this article, contact rdavidson@jobson.com.