DRUG NEWS Many Consumers Exceed Safe Dosages Breaking

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NONPRESCRIPTION NSAIDs HERBAL REMEDY Many consumers exceed Kratom isn’t “just a plant”—it’s an opioid safe dosages The botanical product kratom is used recreationally to self-medicate for pain or opioid withdrawal symptoms. Also known as Mitragyna speciosa, kratom grows An online 1-week diary study of 1,326 naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. ibuprofen users revealed that many In a statement, the FDA announced the results of research showing that almost people exceed the recommended dai- all of kratom’s major compounds bind to opioid receptors in the brain. In addition, ly limit, increasing the risk of adverse the research found that kratom binds as strongly to mu-opioid receptors as sched- reactions. Among the findings: uled opioid drugs. “As the scientific data and adverse event reports have clearly re- • About 90% of participants took vealed, compounds in kratom make it so it isn’t just a plant—it’s an opioid.” over-the-counter ibuprofen during At the time the statement was issued, the FDA had received 44 reports of death associated with kratom use. “Kratom should not be used to treat medical conditions, the week, and 37% also took other nor should it be used as an alternative to prescription opioids,” the FDA warns. “There nonsteroidal anti-inflammatory drugs is no evidence to indicate that kratom is safe or effective for any medical use.” (NSAIDs). Most didn’t realize that the Source: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the drugs are all in the same category. presence of opioid compounds in kratom, underscoring its potential for abuse. U.S. Food and Drug Administration. February 6, 2018. FDA and kratom. U.S. Food and Drug Administration. Feb. 26, 2018. www.fda.gov/NewsEvents/ • Among ibuprofen users, 11% ex- PublicHealthFocus/ucm584952.htm. ceeded the daily limit. • Among users of other NSAIDs, 4% more effective than a once-daily regi- expected increase in deaths among pa- exceeded daily limits. men. However, this requires splitting tients with heart disease who’d received • Exceeding the one-time dose was these small tablets. To determine the a 2-week course of clarithromycin; the the most common deviation from most precise way to do so, researchers increase became apparent after patients instructions on the label. compared subdividing tablets by four had been followed for 1 year or more. Factors associated with exceeding different techniques: breaking by hand, Researchers were unable to identify the the daily limit were male gender, on- cutting with a kitchen knife, and reason for this finding or determine if going pain, poor physical function, splitting with one of two commercial it also applies to patients without heart daily smoking, the attitude that the pill-splitting devices. They found that disease. A new warning about this risk user can choose a suitable dose, not breaking tablets by hand caused the has been added to the clarithromycin starting with the lowest dose, and smallest loss of tablet mass; using a label and the FDA continues to moni- poor knowledge of the recommend- knife caused the greatest loss. “Based on tor safety reports on the drug. The ed one-time and 24-hour doses. the results of our study, we recommend FDA urges clinicians to report adverse Terming the prevalence of exces- hand breaking and to avoid a knife reactions involving clarithromycin (or sive NSAID dosing “nontrivial,” the for the best weight uniform tablets.” any other drug) to its MedWatch pro- authors urge healthcare professionals Source: van Reuler AVR, van Diemen JK, Harmsze AM, gram. An online reporting form can be Fuijkschot WW, Thijs A. Subdivision of aspirin tablets? Use to educate patients about safe NSAID your hands: a study on aspirin tablet subdivision using four accessed at www.fda.org. use and dosage limits, and to con- different methods. J Pharm Pract Res. [e-pub Jan. 24, 2018]. Source: FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased sider other therapeutic options if a long-term risks with antibiotic clarithromycin (Biaxin) patient’s pain isn’t well controlled. HEART DISEASE in patients with heart disease. U.S. Food & Drug Administration. Safety announcement. February 22, 2018. Source: Kaufman DW, Kelly JP, Battista DR, Malone MK, Weinstein RB, Shiffman S. Exceeding the daily dosing limit FDA issues warning about of nonsteroidal anti-inflammatory drugs among ibuprofen users. Pharmacoepidemiol Drug Saf. [e-pub Jan. 26, 2018]. clarithromycin HALOPERIDOL In a recent warning, the FDA states No survival benefit for LOW-DOSE ASPIRIN that the antibiotic clarithromycin has patients at risk for delirium Breaking tablets by hand been found to increase the risk of death in patients with heart disease The use of the antipsychotic haloperi- recommended and recommends that clinicians con- dol to prevent delirium in the ICU Many patients follow a low-dose aspi- sider prescribing alternative antibiotics doesn’t prolong survival, according to rin regimen (75 to 150 mg/day) for to these patients. The warning is based a multicenter randomized, placebo- cardiovascular prophylaxis. Some evi- on results of a 10-year follow-up study controlled trial involving 1,789 dence suggests that dividing the dose of patients with heart disease in a large critically ill patients at high risk for and taking 40 to 75 mg twice a day is clinical trial. Researchers found an un- delirium. The study was conducted www.Nursing2018.com May l Nursing2018 l 9

in the Netherlands, where use of non- the use of prophylactic haloperidol for and a selective, high-affinity serotonin pharmacologic measures for delirium reducing mortality in critically ill adults.” (5-HT4) receptor agonist (prucalo- prevention is the standard of care. Source: van den Boogaard M, Slooter AJC, Brüggemann pride). The meta-analysis included 27 RJM, et al. Effect of haloperidol on survival among critically Patients received I.V. prophylactic ill adults with a high risk of delirium: the REDUCE placebo-controlled trials involving treatment three times daily with 1 mg randomized clinical trial. JAMA. 2018;391(7):680-690. 5,390 patients who received a drug (n = 350) or 2 mg (n = 732) of halo- and 3,491 who received a placebo. peridol, or with the placebo, 0.9% OPIOID-INDUCED CONSTIPATION The study showed that mu-opioid sodium chloride (n = 707). The pri- Therapies compared for receptor antagonists were safe and mary outcome was the number of effective treatments for OIC, and that days patients survived in 28 days. safety, effectiveness prescription-strength laxatives (pru- The 1-mg haloperidol group was Patients on chronic opioid therapy calopride, lubiprostone) were slightly stopped prematurely due to futility. No commonly experience opioid-induced better than placebo for reducing OIC. significant differences in survival days constipation (OIC). To investigate Patients who received mu-opioid re- were found between the remaining the effectiveness of available medica- ceptor antagonists were significantly two groups. In addition, no differences tions used to treat OIC, researchers more likely to have diarrhea, abdomi- were found in any of the 15 secondary analyzed randomized controlled tri- nal pain, nausea, or vomiting compared outcomes, which included delirium inci- als of peripheral mu-opioid receptor with those who received a placebo. ■ dence, delirium-free and coma-free days, antagonists (methylnaltrexone, Source: Nee J, Zakari M, Sugarman MA, et al. Efficacy of treatments for opioid-induced constipation: a systematic duration of mechanical ventilation, and naloxone, naloxegol, alvimopan, review and meta-analysis. Clin Gastroenterol Hepatol. length of hospital stay. The authors con- axelopran, and naldemedine), a chlo- [e-pub Jan 25, 2018]. clude, “These findings do not support ride channel activator (lubiprostone), DOI-10.1097/01.NURSE.0000531903.00171.1b

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