News you can use: health & drug safety updates


  • June 29, 2017

    The Acetaminophen Awareness Coalition reminds health care providers and consumers of potential dosing mistakes that can occur with the use of over-the-counter medicines. The Acetaminophen Awareness Coalition wants to ensure that patients know that FDA recommends taking no more than 4,000 mg of acetaminophen in a 24-hour period, as taking more than directed can lead to liver damage.  The Know Your Dose campaign educates consumers about safe acetaminophen use.

  • June 28, 2017

    The FDA is taking steps to boost the number of generic prescription drugs in an effort to make medicines more affordable. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics and implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.

  • June 23, 2017

    The FDA has implemented its Pregnancy and Lactation Labeling Rule to improve labeling on prescription drugs for pregnant and breastfeeding women. The agency determined that the pregnancy letter category system was too simplistic and did not capture the complexities of available risk information and risk-benefit considerations in relation to prescription drug labeling. The Pregnancy and Lactation Labeling Rule requires pharmaceutical manufacturers to detail the risks and benefits of prescription drugs or biological products for the mother, fetus, infant, and people planning to conceive.

  • June 21, 2017

    The FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

  • June 13, 2017

    Most Americans don’t think twice about taking over-the-counter medication to treat a variety of ailments.

  • June 7, 2017

    The SimplySync website promotes medication synchronization services, commonly known as Med Sync, now being provided by thousands of pharmacies across the country. Medication synchronization programs provide a platform for decreasing trips to the pharmacy, managing refills, and improving medication adherence.  Visit the SimplySync web site to find a pharmacy near you that offers this service.

  • June 6, 2017

    The Patient Education Materials Assessment Tool (PEMAT) is a systematic method to evaluate and compare the understandability and actionability of patient education materials. It is designed as a guide to help determine whether patients will be able to understand and act on information. Separate tools are available for use with print and audiovisual materials. PEMAT was . created by a research team at AHRQ working with a panel of experts in health literacy, content creation, patient education, and communication.

  • June 5, 2017

    Men’s Health Month is intended to heighten the awareness of preventable health problems and encourage early detection and treatment of disease among men and boys. This month gives health care providers, public policy makers, the media, and individuals an opportunity to encourage men and boys to seek regular medical advice and early treatment for disease and injury.

  • June 1, 2017

    Since you can’t always stay indoors when pollen counts are high, your healthcare provider may recommend prescription or over-the-counter (OTC) medications to relieve symptoms. The U.S. Food and Drug Administration (FDA) regulates a number of medications that offer allergy relief. 

  • June 1, 2017

    FDA’s Division of Drug Information is presenting a series of continuing education webinars targeted toward students and health care providers who wish to learn more about FDA and drug regulation. The webinars are presented by FDA staff and will allow participants to interact with staff in a question-and-answer format.  The next webinar, “Ongoing Role of FDA in Medication Error Prevention,” will be held June 6, 2017, at 1 PM (EDT).