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.
Stay Connected
Sign up on our NPTC LISTSERV for latest news, updates, discussions, and drug safety alerts and communications.
Rare occurrence of serious liver injury with use of fezolinetant (Veozah®) for hot flashes due to menopause
Drug-Safety Communication
September 16, 2024Fezolinetant (Veozah®) is a nonhormonal prescription medicine approved in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. The medicine is in a drug class called neurokinin 3 (NK3) receptor antagonists. It works to restore the balance between estrogen hormones and a brain chemical called neurokinin B (NKB) by blocking the activities of the NK3 receptor, which plays a role in the brain's control of body temperature.
Read MoreFDA raises concerns over Delta-8 THC
Drug-Safety Alert
March 15, 2024
Delta-8 tetrahydrocannabinol, also known as delta-8 THC, is a psychoactive substance found in the Cannabis sativa plant. Delta-8 THC is one of over 100 cannabinoids produced naturally by the Cannabis sativa plant but is not found in significant amounts.
Read MoreTianeptine Products Linked to Serious Harm, Overdoses, Death
Drug-Safety Communication
February 9, 2024The U.S. Food and Drug Administration (FDA) issued a public safety alert on November 21, 2023, after receiving multiple reports of serious medical injuries related to "Neptune's Fix." Neptune's Fix is labeled to contain the dangerous and addictive ingredient tianeptine.
Read MorePharmacovigilance Drug Safety Communication
Drug-Safety Communication
January 19, 2024FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine denosumab (Prolia®)
Read MoreRare Serious Side Effect Associated with Levetiracetam and Clobazam
Drug-Safety Communication
November 28, 2023The FDA is warning that the anti-seizure medicines levetiracetam (brand names: Keppra®, Keppra XR®, Elepsia XR®, Spritamand®) and clobazam (brand names: Onfi® and Sympazan®) can cause a rare but serious life-threatening reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Read MoreCorrect Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age
Drug-Safety Alert
November 1, 2023
The Food and Drug Administration (FDA) released a bulletin today through their MedWatch listserv to provide information about the correct dosage and administration of Moderna COVID-19 vaccine (2023-2024 Formula) for individuals 6 months through 11 years of age.
Read MoreCDC Health Update: Potential Risk for New Mpox Cases
Drug-Safety Alert
May 15, 2023
The Centers for Disease Control and Prevention (CDC) released a Health Advisory Network (HAN) Health Update to raise awareness that although cases of mpox (formerly monkeypox) have declined, the CDC continues to receive reports of cases that reflect ongoing community transmission in the United States and internationally. Vaccination continues to be one of the most important prevention measures. Patients with mpox benefit from supportive care and pain control and may be eligible for tecovirimat and JYNNEOS therapies.
Read MoreFDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
Drug-Safety Communication
May 11, 2023The U.S. Food and Drug Administration (FDA) released a drug safety communication to address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants. The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines. Updated Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class and advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.
Read MoreFDA Updates Prescribing Information for all Opioid Pain Medicines to Provide Additional Guidance for Safe Use
Drug-Safety Communication
April 14, 2023The FDA recently released a Drug Safety Communication to raise awareness that there are updates to prescribing information for all opioid pain medications in an effort to improve the safe use of these medications.
Read MoreDEA Reports Widespread Threat of Fentanyl Mixed with Xylazine
Drug-Safety Alert
March 22, 2023
The Drug Enforcement Agency (DEA) issued a Public Safety Alert to warn the American public of a sharp increase in the trafficking of fentanyl mixed with xylazine. Xylazine, also known as "Tranq," is a powerful sedative that the U.S. Food and Drug Administration has approved for veterinary use. The DEA has seized xylazine and fentanyl mixtures in 48 of 50 States. The DEA Laboratory System is reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.
Read MoreOutbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with EzriCare Artificial Tears
Drug-Safety Alert
February 2, 2023
The Centers for Disease Control and Prevention (CDC) issued a Health Advisory to inform patients and clinicians of potential contamination of EzriCare Artificial Tears with a rare strain of extensively drug-resistant P. aeruginosa.
Read MoreIncrease 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.
Read More
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 More