FDA Updates Safety Warnings for Fluoroquinolones

The U.S. Food and Drug Administration (FDA) has announced changes to the safety labeling of fluoroquinolones, including strengthened warnings about the risks of mental health adverse effects and disturbances in blood glucose levels, and more consistent labeling for all fluoroquinolones. The labeling changes require that mental health adverse effects be listed separately from other central nervous system adverse effects, and that they be consistent across the labeling of all drugs in the class. Specific adverse effects to be included are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium. In addition, the blood glucose disturbances subsection of the labeling for all systemic fluoroquinolones will be required to explicitly reflect the potential risk of hypoglycemic coma. FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive), and delafloxacin (Baxdela). For more information, go to https://www.aafp.org/news/health-of-the-public/20180712fluoroquinolones.html.

Title X Change Would Threaten Evidence-Based Care, AAFP Warns

The American Academy of Family Physicians (AAFP) recently warned the U.S. Department of Health and Human Services (HHS) that a proposed change to Title X regulations would force family physicians to omit important medical information necessary for patients to make timely, fully informed decisions about their health care. Title X is the only federal grant program exclusively dedicated to enabling low-income and adolescent patients to access effective family planning and related preventive health services. AAFP President Michael Munger, MD, said that restricting the information patients receive will lead to adverse outcomes. “The AAFP opposes legislative or regulatory restrictions on information that can be given to women, or policies that force physicians to provide women with inaccurate information,” he said. “This could lead to increased rates of unplanned pregnancy, pregnancy complications, and undiagnosed medical conditions.” The statement called on HHS to maintain coverage of evidence-based essential health benefits, such as maternity coverage and women's preventive services, without cost sharing, and supported over-the-counter access to oral contraceptives. For more information, go to https://www.aafp.org/news/government-medicine/20180730titlex.html.

AAFP Calls for Wide-Ranging Approach to Lowering Drug Prices

The AAFP has responded to an HHS request for information on lowering drug prices, outlining its concerns about patients with diabetes mellitus who require medical treatment, potential cost barriers separating children from immunizations, and drugmakers' manipulation of patent details to delay a product's entry to the generic marketplace. The letter said that ensuring access to medications is an integral part of a physician's role as an advocate for patients, and that too often, physicians encounter patients who cannot afford their medications or adhere to treatment recommendations. The AAFP outlined 10 specific areas of concern: (1) generic drug access; (2) drug-pricing principles and priorities; (3) off-patent drugs; (4) site-neutral payments; (5) value-based drug pricing; (6) Medicare negotiation authority; (7) prevention first; (8) transparency; (9) Medicare Part B drugs; and (10) six protected drug classes. For more information, go to https://www.aafp.org/news/government-medicine/20180724hhsdrugsltr.html.

The EveryONE Project Introduces Neighborhood Navigator

The EveryONE Project from the AAFP has launched another tool to help family physicians address social determinants of health at the point of care: the Neighborhood Navigator. This tool, which can accommodate more than 100 languages and is integrated with Google Maps to offer users step-by-step directions, can be used to connect patients to social services for such needs as food, housing, transportation, employment, and legal or financial issues. The EveryONE Project also offers a series of training videos to walk family physicians through using the tool, and physicians can refer patients to a patient-facing version of the tool on https://www.familydoctor.org to enable them to locate services on their own. As a next step of the EveryONE Project, the AAFP will be issuing a comprehensive integrated toolkit for addressing social determinants of health in primary care and advancing health equity through family medicine at the Family Medicine Experience conference in New Orleans in October. For more information, go to https://www.aafp.org/news/health-of-the-public/20180725neighbornav.html.

—AFP and AAFP NEWS STAFF

For more news, visit AAFP News at https://www.aafp.org/news.html.