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FDA targets psychiatric and hypoglycemic risks

The FDA is requiring manufacturers to strengthen labeled warnings about mental health and hypoglycemic risks associated with fluoroquinolone antibiotics, and to make the warnings consistent across the labeling for all fluoroquinolones taken by mouth or injection. The new requirements are based on a comprehensive review of the FDA's adverse event reports and published case reports. Fluoroquinolones include levofloxacin, ciprofloxacin, ciprofloxacin extended-release tablets, moxifloxacin, ofloxacin, gemifloxacin, and delafloxacin.


Adverse mental health effects associated with fluoroquinolones include attention disturbances, disorientation, agitation, nervousness, memory impairment, and delirium. Although mental health risks are already described in the Warnings and Precautions sections in labeling for these drugs, the new rule requires that these adverse reactions be listed separately from other central nervous system adverse reactions.


The FDA review also found incidents of severe hypoglycemia, sometimes leading to coma. Blood glucose disturbances are currently included as a warning in most fluoroquinolone drug labels; the new labels will add that hypoglycemia can lead to coma. This risk is particularly significant for older patients and patients with diabetes taking oral hypoglycemic medication or insulin. Teach patients to recognize and treat signs and symptoms of hypoglycemia and to closely monitor their blood glucose levels during therapy. Also warn them about possible psychiatric adverse reactions, which can occur after just one dose. Fluoroquinolone treatment should be stopped immediately if a patient reports any adverse central nervous system adverse reactions.


Sources: U.S. Food & Drug Administration. FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. News release. July 10, 2018. U.S. Food & Drug Administration. FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes. Safety announcement. July 10, 2018.



Study compares practices in ambulatory settings

In a retrospective cohort study, researchers compared antibiotic prescribing practices during patient visits at urgent care centers, retail clinics, EDs, and medical offices. Antibiotic prescriptions were linked to 39% of 2.7 million urgent care center visits, 36% of 58,206 retail clinic visits, 14% of 4.8 million ED visits, and 7% of 148.5 million medical office visits.


Among visits for antibiotic-inappropriate respiratory diagnoses, antibiotic prescribing was highest in urgent care centers (46%), followed by EDs (25%), medical offices (17%), and retail clinics (14%). "These patterns suggest differences in case mix and evidence of antibiotic overuse, especially in urgent care centers," the researchers comment. "This finding is important because urgent care and retail clinic markets are growing....Antibiotic stewardship interventions could help reduce unnecessary antibiotic prescriptions in all ambulatory care settings, and efforts targeting urgent care centers are urgently needed."


Source: Palms DL, Hicks LA, Bartoces M, et al. Comparison of antibiotic prescribing in retail clinics, urgent care centers, emergency departments, and traditional ambulatory care settings in the United States. JAMA Intern Med. [e-pub July 16, 2018].



Warn parents about these teething remedies

The FDA has directed manufacturers to stop selling or marketing over-the-counter (OTC) teething products containing benzocaine because they pose a serious risk to infants and children. Benzocaine, which is intended to provide temporary relief of gum pain from teething when applied locally, can accumulate in an infant's blood and cause methemoglobinemia, which is potentially fatal. In addition, research has shown that these products aren't effective.


The FDA is also asking manufacturers to add new warnings about the risk of methemoglobinemia to the labeling for all other oral health products containing benzocaine. These products should also be labeled as contraindicated in children under age 2 years under the FDA's new directive. Besides teething, OTC products containing benzocaine are marketed to treat acute pharyngitis and recurrent aphthous stomatitis, also known as canker sores, and are sold as gels, sprays, ointments, solutions, and lozenges.


The FDA recommends that parents follow American Academy of Pediatrics (AAP) recommendations to relieve teething pain. These include use of hard rubber teething rings and gentle massage of the gums with a finger. Tell parents they can find the AAP's recommendations at


Source: U.S. Food & Drug Administration. FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit. News release. May 23, 2018.



Vaccines for high-risk strains effective and safe

Because about 70% of cervical cancers are caused by herpes papillomavirus (HPV) 16 and 18, they're considered high-risk HPV (hrHPV). Persistent infection with hrHPV types raises the risk of cervical precancer and cancer. To determine the effectiveness and potential harms of HPV vaccination, researchers conducted a review of published trials involving over 73,000 adolescent girls and women. Most participants were under age 26. The study involved 26 randomized controlled trials comparing efficacy and safety in females offered HPV vaccines with placebo (vaccine adjuvants or another control vaccine). The researchers found that HPV vaccines protected against cervical precancer in adolescent girls and women who were vaccinated between ages 15 and 26, although the protection was lower if HPV infection was already present. In addition, they found that the vaccines don't increase the risk of serious adverse events, miscarriage, or pregnancy termination.


Source: Arbyn M, Xu L, Simoens C, Martin-Hirsch PP. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Database Syst Rev. 2018;5:CD009069.



Better practices reduce ED visits for diabetes

In a retrospective cohort analysis, investigators studied the association between ambulatory medication reconciliation and healthcare utilization in patients with diabetes. Study subjects were adults taking at least one diabetes medication being treated in primary care practices affiliated with two academic medical centers between 2000 and 2014. The investigators assessed the relationship between the fraction of outpatient diabetes medications reconciled over a 6-month period and the composite primary outcome of combined frequency of ED visits and hospitalizations over the subsequent 6 months. Results were based on 261,765 reconciliation assessment periods contributed by 31,689 patients. Among these, 67%, 11%, and 22% had all, some, or none of the diabetes medications reconciled, respectively.


Adjusting for demographics and comorbidities, the investigators found that having some or all versus no diabetes medications reconciled was associated with a lower risk of the primary outcome. In addition, providing feedback to individual providers was associated with a significant increase in the odds of all diabetes medications being reconciled. They concluded that "a higher fraction of reconciled outpatient diabetes medications was associated with a lower frequency of ED visits and hospitalizations. Individual performance feedback could help to achieve more comprehensive medication reconciliation."


Source: Turchin A, Sosina O, Zhang H, et al. Ambulatory medication reconciliation and frequency of hospitalizations and emergency department visits in patients with diabetes. Diabetes Care. [e-pub June 11, 2018].