A Pharmacist's Guide to OTC Therapy: February 2008

Ms. Terrie is a clinical pharmacy writer based in Haymarket,Va.

Probiotic Supplements

The use of probiotic supplements inthe United States nearly tripled between1994 and 2003.¹ Probiotics arestrains of live microorganisms, comparablewith the beneficial microorganismsnormally present in the gut.^1,2 Thenormal digestive tract contains about400 types of probiotic bacteria that candecrease the growth of harmful bacteria.³ Some theories suggest that the useof probiotics may boost the immunesystem.¹ Probiotics have been linked tosuch actions as competing with pathogensfor the binding sites on intestinalmucosa, reducing intestinal permeability,changes of the intestinal pH, anddirect antimicrobial effect against somepathogens.²

More information on probiotics can be found at the following Web sites:

• NIH's Clinical Trails
• NIH's National Center for Complementary and Alternative Medicine
• USProbiotics.org

NIH = National Institutes of Health.

Probiotics are available in certainfoods (eg, yogurt, buttermilk, somejuices, soy beverages) and in the form ofdietary supplements (capsules, tablets,powders). In both probiotic foods anddietary supplements, the bacteria mayalready be present or added during thepreparation of the products.

Lactobacillus, Bifidobacterium, andSaccharomyces are available probiotics.Within the Lactobacillus strain, Lactobacillusreuteri is the most prevalent inthe human body.² Saccharomyces boulardii(yeast) is the only one of the Saccharomycesthat is used in supplements.²

Probiotics may be used to improvedigestion, restore normal bowel function,prevent or reduce the incidence ofrecurring vaginal yeast infections, andtreat conditions that may change normalintestinal flora (eg, infectious diarrhea,antibiotic-associated diarrhea,traveler?s diarrhea, inflammatory andfunctional bowel conditions).^1,2 Clinicalstudies of probiotics report an estimated79% to 100% efficacy in the preventionof antibiotic-associated diarrhea.²Researchers also are exploring the useof probiotics to prevent and treat urinarytract infections, prevent and manageatopic dermatitis in the pediatricpopulation, and prevent asthma andallergic rhinitis. The role of probiotics inthe treatment and prevention of Helicobacterpylori infections, tooth decay,and periodontal disease is being investigated.¹ Patients who experience constipationand abdominal discomfort alsomay benefit from the use of probioticdietary supplements.⁴

Table

Key Counseling Tips

Before using any probiotic supplement,patients should seek advice fromtheir primary health care provider, particularlythose patients with concurrentmedical conditions and women who arepregnant or breast-feeding. Althoughdata are limited, no harmful results havebeen associated with the use of probioticsin late-term pregnancies or inwomen who breast-feed.²

Some patients using probiotics mayexperience adverse effects (eg, mildepisodes of bloating and flatulence);however, these tend to diminish overtime. Patients who are immunocompromisedshould not use probioticsbecause of the potential for systemicinfections.² Concurrent administrationof probiotic supplements and any antibioticor antifungal agent is not recommended,and dosing intervals of theseagents should be spaced by severalhours.² Patients should be encouragedto discuss the frequency and duration ofuse of these supplements, to use supplementsonly from reputable pharmaceuticalcompanies, and to adhere tothe manufacturer?s dosage guidelines,directions for use, and storage instructions.

References

• An Introduction to Probiotics, Get the Facts. National Center for Complementary and Alternative Medicine Web site. nccam.nih.gov/health/probiotics. Accessed January 10, 2008.
• McQueen C. Nonbotanical Natural Medicines. In: Berardi RR, Kroon LA, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 15th ed. Washington DC: American Public Health Association. 2007; 1137-1140.
• Probiotics. WebMD Web site. www.webmd.com/diet/tc/probiotics-topic-overview. Accessed January 10, 2008.
• Align Product Information. www.aligngi.com. Accessed January 10, 2008.

Weight Management

Obesity rates among adults doubledbetween 1980 and 2004, according tothe Centers for Disease Control andPrevention (CDC). In a report released bythe CDC in November 2007, a studyreported that there has been no significantincrease in rates of obesity between2003 and 2004 and between 2005 and2006 for either men or women, but obesitystill remains a public health issue inthe United States and worldwide.¹ CDCstatistics indicate that from 2005 to 2006an estimated 34% of individuals aged 20years and older were obese.¹ An increasingprevalence of overweight or obesechildren and adolescents exists; approximately17.5% of children (aged 6-11 years) and 17% of adolescents (aged 12-19 years) were overweight during theperiod 2001 to 2004.²

By definition, an adult is consideredoverweight if he or she has a body massindex (BMI) between 25 and 29.9 kg/m²and obese if the adult has a BMI of ≥30 kg/m². Although BMI is used to screen foroverweight in children and adolescents,BMI is not a diagnostic tool for this group;further assessment is needed to determineexcess fat.³ Health risks associatedwith being overweight or obese includehypertension, dyslipidemia, type 2 diabetes,cardiovascular disease, stroke,gallbladder disease, osteoarthritis, sleepapnea and respiratory problems, certaincancers (eg, endometrial, breast, colon),menstrual irregularities, and infertility.^1,2,4

Nonprescription Products

In February 2007, the FDA approvedorlistat (alli), currently the only FDA-approvedOTC weight-loss product. Alli isavailable as 60-mg capsules and is indicatedfor overweight individuals (aged 18years and older) in conjunction with areduced-calorie, low-fat diet and an exerciseprogram. Alli should be taken 3times daily (with main meals containingfat) and may assist patients in losing 50%more weight than by diet alone.

Pharmacists are crucial in identifyingpotential contraindications and druginteractions including cyclosporine andwarfarin. Patients with gallbladder conditions,kidney stones, or pancreatitis orwho are taking thyroid medicationsshould consult their physicians beforetaking alli. Alli should not be used bywomen who are pregnant or breastfeeding.Pharmacists also should ensurethat patients understand the proper useof this product and inform them ofpotential adverse effects (eg, diarrhea,flatulence with oily spotting, increaseddefecation). Pharmacists canencourage individualstakingalli also to takea multivitaminsupplement atleast 2 hoursbefore or aftertaking alli becauseits usemay interferewith a patient's ability to absorb somefat-soluble vitamins. For more information,visit alli's Web site at www.myalli.com.

Dietary Supplements

Although a variety of weight-loss productsare available over the counter thatare marketed to promote weight loss,patients should be aware that many ofthese products lack safety and efficacydata. The use of these dietary weightlosssupplements is not encouraged orrecommended for weight loss becausethey are not proven to promote weightloss and can cause various adverseeffects, especially among patients concurrentlytaking other medications orwho have preexisting medical conditions,which increases the possibility ofpotential drug interactions or contraindications.^4,5 Pharmacists should remindpatients who wish to use these productsto seek advice from their primary healthcare provider before taking them.Dietary weight-loss supplements mayinclude herbal supplements, vitamins,minerals, or amino acids. Products maycontain ingredients such as green tea,chromium, bitter orange, St. John's wort,ginseng, or guarana.⁴ An increasedpotential for drug interactions andadverse effects exists because manyweight-loss supplements contain multipleingredients; patients should beadvised of these effects.

Pharmacists can provide patients withkey information on meal-replacementproducts that may aid in weight loss, thevarious commercial weight-loss programsavailable, and nonpharmacologicmeasures that promote weight loss andmanagement (eg, modifications in diet,caloric restriction, establishing exerciseregimens). Consultation with a nutritionistalso is an option. During counseling,pharmacists can remind patients whodeal with weight issues that a commitmentto weight loss can have a positiveimpact on their overall health. Patientsalso should be encouraged to discusswith their primary health care providerpotential weight-loss options or determinewhether they are candidates forprescription weight-loss drugs or surgeries.Patients with preexisting conditionssuch as diabetes, hypertension, cardiovasculardisease, a history of eating disorders,severe obesity (eg, BMI ≥40), andwomen who are pregnant or breastfeedingshould consult with their primaryhealth care providers for furtherevaluation.⁴

References

and please have it go here: http://www.aligngi.com/index.shtml

• Obesity Among Adults in the United States— No Statistically Significant Change Since 2003-2004. Centers for Disease Control Web site. www.cdc.gov/nchs/data/databriefs/db01.pdf. Accessed January 9, 2008.
• Statistics Related to Overweight and Obesity. Weight-control Information Network. National Institute of Diabetes and Digestive and Kidney Diseases Web site. win.niddk.nih.gov/index.htm. Accessed January 9, 2008.
• Defining Overweight and Obesity. Centers for Disease Control and Prevention Web site. www.cdc.gov/nccdphp/dnpa/obesity/defining.htm. Accessed January 9, 2008.
• Miller S, Bartels Cathy. Overweight and Obesity. In: Berardi RR, Kroon LA, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 15th ed. Washington DC: American Public Health Association. 2007; 553-573.
• Beers M, Porter RS, Jones T. Obesity and the Metabolic Syndrome. In: The Merck Manual of Diagnosis and Therapy. 18th ed. Whitehouse Station, NJ: Merck & Co, Inc. 2006; 56-61.