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- Food and Drug Administration (FDA)
FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2018.
Journal Article > Study
Effect of US Drug Enforcement Administration's rescheduling of hydrocodone combination analgesic products on opioid analgesic prescribing.
Jones CM, Lurie PG, Throckmorton DC. JAMA Intern Med. 2016;176:399-402.
Improving the safety associated with opioid use is a major health policy priority. Investigators found that drug scheduling changes imposed by the US Drug Enforcement Administration (including tighter prescribing standards and prohibiting refills) led to major reductions in the prescribing and dispensing of hydrocodone combination analgesic products.
FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; September 23, 2013.
This announcement explains a label change to a medication patch intended to reduce risk of accidental exposure.
Rockville, MD: US Food and Drug Administration; 2013.
To protect children and pets from accidental exposure to prescription medications, this consumer alert outlines the dangers of inappropriate storage and disposal of medication skin patches.
Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 15, 2012.
This announcement reveals risks associated with administering codeine after a common pediatric procedure.
Hydrocodone bitartrate and acetaminophen tablets, phenobarbital tablets by Qualitest: recall—incorrect package labeling.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 7, 2011.
This announcement reports the recall of two products that may have been mislabeled.
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL): medication use error—reports of accidental overdose.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 10, 2011.
This announcement reveals a labeling change to reduce the potential for misadministration of a pain medication.
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.
FDA Public Health Advisory. Silver Spring, MD: US Food and Drug Administration; December 21, 2007.
This Food and Drug Administration public health advisory alerts health care professionals, patients, and their caregivers to the possibility for overdoses of fentanyl in patients using fentanyl skin patches for pain control.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; September 13, 2007.
This announcement provides specific instructions on safe prescribing of a cancer pain medication in response to several patient deaths associated with off-label use.
Food and Drug Administration (FDA) Patient Safety News. Show #60. February 2007.
This video segment shares recommendations for providers about safe prescribing of methadone for pain control, including heightened patient monitoring and encouraging patients to ask questions about how the drug will affect them.