Medication Safety Resources
Recent Safety Resources
Important FDA communications regarding the prescribing and monitoring of FDA approved medications and devices are listed here. Drug Safety Communications (DSC) are the result of pharmacovigilance through clinical research findings and post marketing surveillance data. A listing of recent DSC can be found on the FDA website Drug Safety Alerts (DSAs) provide important information about the safe and effective use of one or more medications. Drug safety alerts provide information about current topics and findings to help raise awareness and promote medication safety.
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Increase in Pediatric Invasive Group A Streptococcal Infections
Drug-Safety Alert
December 22, 2022
The Centers for Disease Control and Prevention (CDC) issued a Health Advisory to notify clinicians and public health authorities of a recent increase in pediatric invasive group A streptococcal (iGAS) infections.
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Interim Guidance for Clinicians to Prioritize Antiviral Treatment of Influenza in the Setting of Reduced Availability of Oseltamivir
Drug-Safety Alert
December 15, 2022The Centers for Disease Control and Prevention (CDC) issued a Health Advisory to provide guidance on antiviral treatment of influenza in the setting of reduced availability of oseltamivir.
Read MoreRisk of severe hypocalcemia in patients on dialysis receiving denosumab
Drug-Safety Communication
November 22, 2022FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine denosumab (Prolia®).
Read MoreReport Potential JYNNEOS Adverse Vaccine Events to VAERS
Drug-Safety Alert
September 1, 2022Vaccination providers who are administering JYNNEOS under the EUA are required to report adverse events that occur afterward.
Read MorePossible increased risk of death, serious side effects with duvelisib (Copiktra)
Drug-Safety Communication
June 30, 2022The FDA warns of a possible increased risk of death with the cancer drug, duvelisib (Copiktra) used in the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Read MoreFDA Withdraws Approval for Umbralisib (Ukoniq) Due to Safety Concerns
Drug-Safety Communication
June 1, 2022The FDA is withdrawing its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Read MoreCOVID-19 Rebound After Paxlovid Treatment
Drug-Safety Alert
May 25, 2022
The Centers for Disease Control and Prevention (CDC) released a Health Advisory Network (HAN) Health Advisory on the potential for recurrence of COVID-19 or "COVID-19 rebound."
Read MoreAdditional Paxlovid Dose Packs Authorized for Patients with Moderate Renal Impairment
Drug-Safety Alert
April 15, 2022The FDA revised the EUA for Paxlovid, authorizing an additional dose pack with appropriate dosing for patients with moderate renal impairment.
Read MoreFDA: Monitor Babies & Young Children Who Receive Injections of Iodine-Containing Contrast Media
Drug-Safety Communication
March 30, 2022The FDA recommends that newborns and children through 3 years old have thyroid monitoring within 3 weeks post-injection of iodinated contrast media for medical imaging procedures.
Read MorePossible Increased Risk for Death with Umbralisib (Ukoniq)
Drug-Safety Communication
February 3, 2022The FDA released a warning of possible increased risk of death with umbralisib (Ukoniq) used for the treatment of lymphoma.
Read MoreDental Problems Have Been Reported with Medicines Containing Buprenorphine that are Dissolved in the Mouth
Drug-Safety Communication
January 12, 2022The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.
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