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Many consumers exceed safe dosages

An online 1-week diary study of 1,326 ibuprofen users revealed that many people exceed the recommended daily limit, increasing the risk of adverse reactions. Among the findings:


* About 90% of participants took over-the-counter ibuprofen during the week, and 37% also took other nonsteroidal anti-inflammatory drugs (NSAIDs). Most didn't realize that the drugs are all in the same category.


* Among ibuprofen users, 11% exceeded the daily limit.


* Among users of other NSAIDs, 4% exceeded daily limits.


* Exceeding the one-time dose was the most common deviation from instructions on the label.



Factors associated with exceeding the daily limit were male gender, ongoing pain, poor physical function, daily smoking, the attitude that the user can choose a suitable dose, not starting with the lowest dose, and poor knowledge of the recommended one-time and 24-hour doses.


Terming the prevalence of excessive NSAID dosing "nontrivial," the authors urge healthcare professionals to educate patients about safe NSAID use and dosage limits, and to consider other therapeutic options if a patient's pain isn't well controlled.


Source: Kaufman DW, Kelly JP, Battista DR, Malone MK, Weinstein RB, Shiffman S. Exceeding the daily dosing limit of nonsteroidal anti-inflammatory drugs among ibuprofen users. Pharmacoepidemiol Drug Saf. [e-pub Jan. 26, 2018].



Breaking tablets by hand recommended

Many patients follow a low-dose aspirin regimen (75 to 150 mg/day) for cardiovascular prophylaxis. Some evidence suggests that dividing the dose and taking 40 to 75 mg twice a day is more effective than a once-daily regimen. However, this requires splitting these small tablets. To determine the most precise way to do so, researchers compared subdividing tablets by four different techniques: breaking by hand, cutting with a kitchen knife, and splitting with one of two commercial pill-splitting devices. They found that breaking tablets by hand caused the smallest loss of tablet mass; using a knife caused the greatest loss. "Based on the results of our study, we recommend hand breaking and to avoid a knife for the best weight uniform tablets."


Source: van Reuler AVR, van Diemen JK, Harmsze AM, Fuijkschot WW, Thijs A. Subdivision of aspirin tablets? Use your hands: a study on aspirin tablet subdivision using four different methods. J Pharm Pract Res. [e-pub Jan. 24, 2018].



FDA issues warning about clarithromycin

In a recent warning, the FDA states that the antibiotic clarithromycin has been found to increase the risk of death in patients with heart disease and recommends that clinicians consider prescribing alternative antibiotics to these patients. The warning is based on results of a 10-year follow-up study of patients with heart disease in a large clinical trial. Researchers found an unexpected increase in deaths among patients with heart disease who'd received a 2-week course of clarithromycin; the increase became apparent after patients had been followed for 1 year or more. Researchers were unable to identify the reason for this finding or determine if it also applies to patients without heart disease. A new warning about this risk has been added to the clarithromycin label and the FDA continues to monitor safety reports on the drug. The FDA urges clinicians to report adverse reactions involving clarithromycin (or any other drug) to its MedWatch program. An online reporting form can be accessed at http://www.fda.org.


Source: FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease. U.S. Food & Drug Administration. Safety announcement. February 22, 2018.



No survival benefit for patients at risk for delirium

The use of the antipsychotic haloperidol to prevent delirium in the ICU doesn't prolong survival, according to a multicenter randomized, placebo-controlled trial involving 1,789 critically ill patients at high risk for delirium. The study was conducted in the Netherlands, where use of nonpharmacologic measures for delirium prevention is the standard of care.


Patients received I.V. prophylactic treatment three times daily with 1 mg (n = 350) or 2 mg (n = 732) of haloperidol, or with the placebo, 0.9% sodium chloride (n = 707). The primary outcome was the number of days patients survived in 28 days.


The 1-mg haloperidol group was stopped prematurely due to futility. No significant differences in survival days were found between the remaining two groups. In addition, no differences were found in any of the 15 secondary outcomes, which included delirium incidence, delirium-free and coma-free days, duration of mechanical ventilation, and length of hospital stay. The authors conclude, "These findings do not support the use of prophylactic haloperidol for reducing mortality in critically ill adults."


Source: van den Boogaard M, Slooter AJC, Bruggemann RJM, et al. Effect of haloperidol on survival among critically ill adults with a high risk of delirium: the REDUCE randomized clinical trial. JAMA. 2018;391(7):680-690.



Therapies compared for safety, effectiveness

Patients on chronic opioid therapy commonly experience opioid-induced constipation (OIC). To investigate the effectiveness of available medications used to treat OIC, researchers analyzed randomized controlled trials of peripheral mu-opioid receptor antagonists (methylnaltrexone, naloxone, naloxegol, alvimopan, axelopran, and naldemedine), a chloride channel activator (lubiprostone), and a selective, high-affinity serotonin (5-HT4) receptor agonist (prucalopride). The meta-analysis included 27 placebo-controlled trials involving 5,390 patients who received a drug and 3,491 who received a placebo.


The study showed that mu-opioid receptor antagonists were safe and effective treatments for OIC, and that prescription-strength laxatives (prucalopride, lubiprostone) were slightly better than placebo for reducing OIC. Patients who received mu-opioid receptor antagonists were significantly more likely to have diarrhea, abdominal pain, nausea, or vomiting compared with those who received a placebo.


Source: Nee J, Zakari M, Sugarman MA, et al. Efficacy of treatments for opioid-induced constipation: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. [e-pub Jan 25, 2018].



Kratom isn't "just a plant"-it's an opioid

The botanical product kratom is used recreationally to self-medicate for pain or opioid withdrawal symptoms. Also known as Mitragyna speciosa, kratom grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea.


In a statement, the FDA announced the results of research showing that almost all of kratom's major compounds bind to opioid receptors in the brain. In addition, the research found that kratom binds as strongly to mu-opioid receptors as scheduled opioid drugs. "As the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn't just a plant-it's an opioid."


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, nor should it be used as an alternative to prescription opioids," the FDA warns. "There is no evidence to indicate that kratom is safe or effective for any medical use."


Source: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's scientific evidence on the 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. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm584952.htm.