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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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FDA 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.

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Tianeptine Products Linked to Serious Harm, Overdoses, Death

Drug-Safety Communication

February 9, 2024

The 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.

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Pharmacovigilance Drug Safety Communication

Drug-Safety Communication

January 19, 2024

FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine denosumab (Prolia®)

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Rare Serious Side Effect Associated with Levetiracetam and Clobazam

Drug-Safety Communication

November 28, 2023

The 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).

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Correct 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.

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CDC 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.

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FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions

Drug-Safety Communication

May 11, 2023

The 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.

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FDA Updates Prescribing Information for all Opioid Pain Medicines to Provide Additional Guidance for Safe Use

Drug-Safety Communication

April 14, 2023

The 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.

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DEA 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.

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Outbreak 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.

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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, 2022

The 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.

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Risk of severe hypocalcemia in patients on dialysis receiving denosumab

Drug-Safety Communication

November 22, 2022

FDA 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®).

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Report Potential JYNNEOS Adverse Vaccine Events to VAERS


Drug-Safety Alert

September 1, 2022

Vaccination providers who are administering JYNNEOS under the EUA are required to report adverse events that occur afterward.

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Possible increased risk of death, serious side effects with duvelisib (Copiktra)

Drug-Safety Communication

June 30, 2022

The 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).

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FDA Withdraws Approval for Umbralisib (Ukoniq) Due to Safety Concerns

Drug-Safety Communication

June 1, 2022

The 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).

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COVID-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."

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Additional Paxlovid Dose Packs Authorized for Patients with Moderate Renal Impairment

Drug-Safety Alert

April 15, 2022

The FDA revised the EUA for Paxlovid, authorizing an additional dose pack with appropriate dosing for patients with moderate renal impairment.

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FDA: Monitor Babies & Young Children Who Receive Injections of Iodine-Containing Contrast Media

Drug-Safety Communication

March 30, 2022

The 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.

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Possible Increased Risk for Death with Umbralisib (Ukoniq)



Drug-Safety Communication

February 3, 2022

The FDA released a warning of possible increased risk of death with umbralisib (Ukoniq) used for the treatment of lymphoma.

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