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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 Exit Disclaimer: You Are Leaving www.ihs.gov . 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, 2021

Seasonal 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, 2021

FDA 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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Drug-Safety Alert

August 26, 2021

Reports 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, 2021

FDA 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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Drug-Safety Alert

July 15, 2021

Revised 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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Drug-Safety Alert

June 28, 2021

Revised 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, 2021

Alcohol-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, 2021

Myocarditis & 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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Drug-Safety Communication

May 25, 2021

FDA 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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Drug-Safety Alert

April 26, 2021

Pause 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, 2021

Adverse 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, 2021

Abuse 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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Drug-Safety Communication

February 4, 2021

Tofacitinib (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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Drug-Safety Alert

January 6, 2021

One 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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Drug-Safety Alert

January 6, 2021

Vaccine 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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