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FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.
Silver Spring, MD: US Food and Drug Administration; April 9, 2019.
Efforts to address the opioid epidemic range from regulation to changes in pain management. This safety announcement raises awareness of potential harms associated with rapidly decreasing the dose of or discontinuing opioids for patients who may be physically dependent on the medication. It also announces a requirement regarding changes to prescribing information for opioids to provide expanded guidance on how to safely taper doses. Health care providers should discuss tapering plans with patients and provide ongoing monitoring and support.
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 14, 2018.
This safety announcement raises awareness of pump failures, dosing errors, and other potential safety issues associated with implanted pumps. Recommendations to enhance safety include review of medication labeling to select appropriate medicines and concentrations as well as open discussions with patients about risks associated with pump and medication options.
FDA Public Health Advisory [US Food and Drug Administration Web site]. March 11, 2008.
This announcement alerts parents and health care professionals about the potentially fatal dangers of Tussionex Pennkinetic Extended-Release Suspension, a prescription cough medicine that should not be used in children younger than 6 years.
Consumers Filling U.S. Prescriptions Abroad May Get the Wrong Active Ingredient Because of Confusing Drug Names.
FDA Public Health Advisory [US Food and Drug Administration Web site]. January 2006.
This U.S. Food and Drug Administration advisory alerts clinicians and consumers to potential mistakes in prescriptions purchased abroad. The advisory includes a table of medications known to contain different active ingredients when purchased outside the United States.
Rados C. FDA Consum. 2005;39:35-37.
This article reports on problems with drug names, the naming process for medications, and both industry and consumer actions that can minimize misunderstandings.