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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Drug-Safety Alert
October 6, 2021Seasonal Influenza Vaccine Safety: Reporting Adverse Vaccine Events to the Vaccine Adverse Event Reporting System (VAERS)
With flu season coming up, please remember to submit Adverse Vaccine Events (AVEs) from all vaccines to the Vaccine Adverse Event Reporting System (VAERS) in accordance with the Indian Health Manual and/or your local policies.
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Drug-Safety Communication
September 1, 2021FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions.
Janus Kinase (JAK) inhibitors decrease the activity of the immune system and treat conditions such as rheumatoid arthritis and ulcerative colitis.
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August 26, 2021Reports of Severe Illness Associated with Use of Products Containing Ivermectin to Prevent or Treat COVID-19
The Centers for Disease Control (CDC) issued a health advisory on August 26th describing an increase in the misuse of ivermectin as a treatment or prevention of COVID-19 disease.
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Drug-Safety Communication
July 19, 2021FDA Requests the Removal of Pregnancy as a Contraindication Against using Stains
Statin use may be considered in very-high risk pregnant patients. Most patients should stop statins if they are pregnant. Temporary discontinuation of lipid lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients.
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July 15, 2021Revised Fact Sheets: FDA Warns of Increased Risk of Guillain-Barré Syndrome following Janssen COVID-19 Vaccination
On July 13, 2021, the FDA announced revisions to the vaccine recipient and provider fact sheets for the Johnson & Johnson COVID-19 vaccine to include information pertaining to an observed increased risk of Guillain-Barré syndrome following vaccination.
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June 28, 2021Revised Fact Sheets: Myocarditis & Pericarditis Following mRNA COVID-19 Vaccination
On June 25, 2021, the FDA announced revisions to the patient and provider fact sheets for the Pfizer-BioNTech and Moderna COVID-19 vaccines regarding the suggested increased risks of myocarditisand pericarditis following vaccination.
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Drug-Safety Communication
June 16, 2021Alcohol-Based Hand Sanitizers
The Food & Drug Administration (FDA) has released a drug safety communication today, warning of reports of side effects after applying alcohol-based hand sanitizers on their skin. Reported side effects may include: headache, nausea, and dizziness.
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Drug-Safety Alert
May 28, 2021Myocarditis & Pericarditis Following mRNA COVID-19 Vaccination
Since April 2021, increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna), particularly in adolescents and young adults.
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May 25, 2021FDA Restricts Use of Obeticholic Acid (Ocaliva®) in Some Primary Biliary Cholangitis (PBC) Patients
The FDA identified 25 PBC patients with cirrhosis who took obeticholic acid, especially those with evidence of advanced cirrhosis, who developed liver failure, sometimes requiring liver transplant.
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April 26, 2021Pause Lifted on Johnson & Johnson COVID-19 Vaccine Use
The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
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Drug-Safety Alert
April 15, 2021Adverse Vaccine Events Potentially Associated with the Johnson & Johnson/Janssen COVID-19 Vaccine
Six adverse vaccine events of CVST with thrombocytopenia have been reported after the administration of the Johnson & Johnson/Janssen COVID-19 vaccine in the United States.
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Drug-Safety Communication
March 25, 2021Abuse and misuse of propylhexedrine nasal decongestant causes serious
Data from the U.S. Poison Control Centers, MedWatch, and published literature highlight the abuse of propylhexedrine alone or with other substances resulting in adverse drug events, some events were life-threatening, resulted in hospitalization, or death.
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February 4, 2021Tofacitinib (Xeljanz®) may increase risk of serious heart-related problems and cancer
The FDA has issued a Drug Safety Communication (DSC) to alert clinicians about risks of heartrelated problems and cancer with the use of tofacitinib.
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January 6, 2021One Vial of BAMLANIVIMAB Must Be Combined with Two Vials of ETESEVIMAB for Infusion
Bamlanivimab and etesevimab are available as a solution in separate vials. One dose of therapy contains 1 vial of bamlanivimab and 2 vials of etesevimab.
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January 6, 2021Vaccine Safety: Anaphylaxis and COVID-19 Vaccinations
The CDC Advisory Committee on Immunization Practices has issued interim recommendations for the Pfizer-BioNTech and Moderna COVID-19 vaccines for prevention of COVID-19 in the US.
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