Pharmacy & Therapeutics - June 2008 - (Page 363)

Pharmaceutical Approval Update Warnings and Precautions: Pregnancy. The safety of lubiprostone in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone had the potential to cause fetal loss. This agent should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. Women who could become pregnant should have a negative pregnancy test before beginning therapy with lubiprostone and should be capable of complying with effective contraceptive measures. Nausea. Patients taking lubiprostone may experience nausea. If this occurs, concomitant administration of food may reduce symptoms. Diarrhea. Lubiprostone should not be prescribed for patients with severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment, and they should be instructed to inform their physician if severe diarrhea occurs. Dyspnea. In clinical trials, dyspnea was reported in 2.5% of the treated patients with chronic idiopathic constipation and in 0.4% of the treated patients with IBS-C. Although adverse events were not classified as serious, some patients discontinued treatment because of dyspnea. Dyspnea has usually been described as a sensation of chest tightness and difficulty in taking in a breath, generally with an acute onset within 30 to 60 minutes after taking the first dose. There have been postmarketing reports of dyspnea when lubiprostone was used at a dose of 24 mcg. Symptoms of dyspnea generally resolved within a few hours after patients took the dose, but recurrence has been frequently reported with subsequent doses of lubiprostone. Bowel obstruction: In patients with symptoms suggesting mechanical gastrointestinal obstruction, the physician should perform a thorough evaluation to confirm the absence of such an obstruction before initiating therapy with lubiprostone. Dosage and Administration: Lubiprostone should be taken twice daily orally with food and water. Physicians and patients should periodically assess the need for continued therapy. Irritable bowel syndrome with constipation. The recommended dose is 8 mcg taken twice daily orally with food and water. Chronic idiopathic constipation. The recommended dose is 24 mcg taken twice daily orally with food and water. Commentar y: IBS is a chronic, recurrent disorder characterized by the multiple symptoms of abdominal pain and discomfort, bloating, and extreme changes of bowel habits such as constipation, diarrhea, or both. IBS is considered to be one of the most common gastrointestinal (GI) disorders. Approximately 30 million people in North America meet the diagnostic criteria for IBS. According to the American Gastroenterological Association, the cause of IBS is unknown, although lifestyle factors (including diet) and psychological stress may play a role. IBS affects 1 in 10 adults in the U.S., making it one of the most common ailments diagnosed by physicians. Both IBS (especially IBS-C) and chronic idiopathic constipation are common GI conditions that occur more frequently in women; 60% to 70% of patients are women. IBS is the most common diagnosis by gastroenterologists and causes a great deal of discomfort and distress for patients. IBS is not life-threatening, but it can significantly interfere with daily activities and can reduce the patient’s quality of life. Although the approval of lubiprostone offers a medication that can provide overall symptom relief for the millions of adult women in the U.S., physicians must be cautious, because the drug has not been studied in pregnant women. It should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Sources: www.amitiza.com; www.drugs.com/nda/lubiprostone_05041.html; www.womenshealthcareforum.com/ IBS.cfm I MEDICATION ERRORS continued from page 320 • BenefitsCheckUp (www.benefitscheckup.org) • Medicare (www.medicare.gov) • RxAssist (www.rxassist.org/default.cfm) • Needy Meds (www.needymeds.com) 4. Alerting patients to the risk of buying drugs from Internet sources. Some Internet-based pharmacies are not properly licensed, or the medications may originate from a foreign country where counterfeit drugs are rampant. Patients should be advised to make sure that the Internet pharmacy they intend to use is properly credentialed. Patients can look for the National Association of Boards of Pharmacy Verified Internet Pharmacy Practice Sites seal on the Web site to ensure proper licensing and safety. Other verification sources are also being sought in Canada to provide consumers with confidence that drugs purchased online are safe. 5. Investigating problems. If clinical problems arise, it should not be assumed that patients have been taking their medications as prescribed. Health care providers should always ask patients about their compliance with regimens in an empathetic, nonthreatening way before changing the plan of care or increasing the dose of previously prescribed medications. REFERENCE 1. Ipsos in North America. Available at: www. ipsos-na.com/news/ pressrelease.cfm?id= 2064. Accessed April 25, 2008. The reports described in this column were received through the USP–ISMP Medication Errors Reporting Program (MERP). Errors, close calls, or hazardous conditions may be reported on the ISMP (www.ismp.org) or the USP (www.usp.org) Web site or communicated directly to ISMP by calling 1-800-FAILSAFE or via e-mail at ismpinfo@ismp.org. I Vol. 33 No. 6 • June 2008 • P&T® 363 http://www.amitiza.com http://www.drugs.com/nda/lubiprostone_05041.html http://www.drugs.com/nda/lubiprostone_05041.html http://www.womenshealthcareforum.com/IBS.cfm http://www.womenshealthcareforum.com/IBS.cfm http://www.benefitscheckup.org http://www.medicare.gov http://www.rxassist.org/default.cfm http://www.needymeds.com http://ipsos-na.com/news/pressrelease.cfm?id=2064 http://ipsos-na.com/news/pressrelease.cfm?id=2064 http://www.ismp.org http://www.usp.org

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Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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