A Pharmacist's Guide to OTC Therapy

FEBRUARY 01, 2008
Yvette C. Terrie, BSPharm, RPh

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

Probiotic Supplements
Weight Management

Probiotic Supplements

The use of probiotic supplements in the United States nearly tripled between 1994 and 2003.1 Probiotics are strains of live microorganisms, comparable with the beneficial microorganisms normally present in the gut.1,2 The normal digestive tract contains about 400 types of probiotic bacteria that can decrease the growth of harmful bacteria.3 Some theories suggest that the use of probiotics may boost the immune system.1 Probiotics have been linked to such actions as competing with pathogens for the binding sites on intestinal mucosa, reducing intestinal permeability, changes of the intestinal pH, and direct antimicrobial effect against some pathogens.2

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

NIH = National Institutes of Health.

Probiotics are available in certain foods (eg, yogurt, buttermilk, some juices, soy beverages) and in the form of dietary supplements (capsules, tablets, powders). In both probiotic foods and dietary supplements, the bacteria may already be present or added during the preparation of the products.

Lactobacillus, Bifidobacterium, and Saccharomyces are available probiotics. Within the Lactobacillus strain, Lactobacillus reuteri is the most prevalent in the human body.2 Saccharomyces boulardii (yeast) is the only one of the Saccharomyces that is used in supplements.2

Probiotics may be used to improve digestion, restore normal bowel function, prevent or reduce the incidence of recurring vaginal yeast infections, and treat conditions that may change normal intestinal flora (eg, infectious diarrhea, antibiotic-associated diarrhea, traveler?s diarrhea, inflammatory and functional bowel conditions).1,2 Clinical studies of probiotics report an estimated 79% to 100% efficacy in the prevention of antibiotic-associated diarrhea.2 Researchers also are exploring the use of probiotics to prevent and treat urinary tract infections, prevent and manage atopic dermatitis in the pediatric population, and prevent asthma and allergic rhinitis. The role of probiotics in the treatment and prevention of Helicobacter pylori infections, tooth decay, and periodontal disease is being investigated.1 Patients who experience constipation and abdominal discomfort also may benefit from the use of probiotic dietary supplements.4


Key Counseling Tips

Before using any probiotic supplement, patients should seek advice from their primary health care provider, particularly those patients with concurrent medical conditions and women who are pregnant or breast-feeding. Although data are limited, no harmful results have been associated with the use of probiotics in late-term pregnancies or in women who breast-feed.2

Some patients using probiotics may experience adverse effects (eg, mild episodes of bloating and flatulence); however, these tend to diminish over time. Patients who are immunocompromised should not use probiotics because of the potential for systemic infections.2 Concurrent administration of probiotic supplements and any antibiotic or antifungal agent is not recommended, and dosing intervals of these agents should be spaced by several hours.2 Patients should be encouraged to discuss the frequency and duration of use of these supplements, to use supplements only from reputable pharmaceutical companies, and to adhere to the manufacturer?s dosage guidelines, directions for use, and storage instructions.


  1. 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.
  2. 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.
  3. Probiotics. WebMD Web site. www.webmd.com/diet/tc/probiotics-topic-overview. Accessed January 10, 2008.
  4. Align Product Information. www.aligngi.com. Accessed January 10, 2008.

Weight Management

Obesity rates among adults doubled between 1980 and 2004, according to the Centers for Disease Control and Prevention (CDC). In a report released by the CDC in November 2007, a study reported that there has been no significant increase in rates of obesity between 2003 and 2004 and between 2005 and 2006 for either men or women, but obesity still remains a public health issue in the United States and worldwide.1 CDC statistics indicate that from 2005 to 2006 an estimated 34% of individuals aged 20 years and older were obese.1 An increasing prevalence of overweight or obese children and adolescents exists; approximately 17.5% of children (aged 6-11 years) and 17% of adolescents (aged 12-19 years) were overweight during the period 2001 to 2004.2

By definition, an adult is considered overweight if he or she has a body mass index (BMI) between 25 and 29.9 kg/m2 and obese if the adult has a BMI of ≥30 kg/m2. Although BMI is used to screen for overweight in children and adolescents, BMI is not a diagnostic tool for this group; further assessment is needed to determine excess fat.3 Health risks associated with being overweight or obese include hypertension, dyslipidemia, type 2 diabetes, cardiovascular disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and respiratory problems, certain cancers (eg, endometrial, breast, colon), menstrual irregularities, and infertility.1,2,4

Nonprescription Products

In February 2007, the FDA approved orlistat (alli), currently the only FDA-approved OTC weight-loss product. Alli is available as 60-mg capsules and is indicated for overweight individuals (aged 18 years and older) in conjunction with a reduced-calorie, low-fat diet and an exercise program. Alli should be taken 3 times daily (with main meals containing fat) and may assist patients in losing 50% more weight than by diet alone.

Pharmacists are crucial in identifying potential contraindications and drug interactions including cyclosporine and warfarin. Patients with gallbladder conditions, kidney stones, or pancreatitis or who are taking thyroid medications should consult their physicians before taking alli. Alli should not be used by women who are pregnant or breastfeeding. Pharmacists also should ensure that patients understand the proper use of this product and inform them of potential adverse effects (eg, diarrhea, flatulence with oily spotting, increased defecation). Pharmacists can encourage individuals taking alli also to take a multivitamin supplement at least 2 hours before or after taking alli because its use may interfere with a patient's ability to absorb some fat-soluble vitamins. For more information, visit alli's Web site at www.myalli.com.

Dietary Supplements

Although a variety of weight-loss products are available over the counter that are marketed to promote weight loss, patients should be aware that many of these products lack safety and efficacy data. The use of these dietary weightloss supplements is not encouraged or recommended for weight loss because they are not proven to promote weight loss and can cause various adverse effects, especially among patients concurrently taking other medications or who have preexisting medical conditions, which increases the possibility of potential drug interactions or contraindications. 4,5 Pharmacists should remind patients who wish to use these products to seek advice from their primary health care provider before taking them. Dietary weight-loss supplements may include herbal supplements, vitamins, minerals, or amino acids. Products may contain ingredients such as green tea, chromium, bitter orange, St. John's wort, ginseng, or guarana.4 An increased potential for drug interactions and adverse effects exists because many weight-loss supplements contain multiple ingredients; patients should be advised of these effects.

Pharmacists can provide patients with key information on meal-replacement products that may aid in weight loss, the various commercial weight-loss programs available, and nonpharmacologic measures that promote weight loss and management (eg, modifications in diet, caloric restriction, establishing exercise regimens). Consultation with a nutritionist also is an option. During counseling, pharmacists can remind patients who deal with weight issues that a commitment to weight loss can have a positive impact on their overall health. Patients also should be encouraged to discuss with their primary health care provider potential weight-loss options or determine whether they are candidates for prescription weight-loss drugs or surgeries. Patients with preexisting conditions such as diabetes, hypertension, cardiovascular disease, a history of eating disorders, severe obesity (eg, BMI ≥40), and women who are pregnant or breastfeeding should consult with their primary health care providers for further evaluation.4


and please have it go here: http://www.aligngi.com/index.shtml
  1. 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.
  2. 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.
  3. Defining Overweight and Obesity. Centers for Disease Control and Prevention Web site. www.cdc.gov/nccdphp/dnpa/obesity/defining.htm. Accessed January 9, 2008.
  4. 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.
  5. 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.