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  4. Surveillance: Post Drug-Approval Activities
  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. January - March 2016 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

January - March 2016 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of October 25, 2023)

Aripiprazole-containing drug products:

  • Abilify (aripiprazole) orally disintegrating tablet, tablet, oral solution, and injection for intramuscular (IM) use
  • Abilify Maintena (aripiprazole) extended-release injectable suspension for IM use
  • Aristada (aripiprazole lauroxil) extended-release injectable suspension for IM use

Impulse-control disorders

Updated

The “Warnings and Precautions” section of the labeling for Abilify was updated August 2016 to include impulse-control disorders.

Example: Abilify labeling

Aripiprazole Drug Safety Communication (May 3, 2016)

Belviq (lorcaserin hydrochloride) tablets

Hypersensitivity

Updated

The “Contraindications” and “Adverse Reactions” sections of the labeling for Belviq were updated May 2017 to include hypersensitivity.

Belviq labeling

Brilinta (ticagrelor) tablets

Atrioventricular block (AV block)

Updated

The “Warnings and Precautions” section of the labeling for Brilinta was updated September 2016 to include atrioventricular block.

Brilinta labeling

Cometriq (cabozantinib) capsules

Drug interaction between cabozantinib and warfarin

FDA decided that no action is necessary at this time based on available information.

  • Cysto-Conray II (iothalamate meglumine) injection
  • Gastrografin (diatrizoate meglumine and diatrizoate sodium) solution
  • MD-Gastroview (diatrizoate meglumine and diatrizoate sodium) solution

Medication error reports associated with wrong route of administration

Updated

FDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.

Diflucan (fluconazole) tablets

Adverse pregnancy outcomes

Updated

The “Warnings,” “Precautions,” and “Patient Information” sections of the labeling for Diflucan were updated March 2018 to include adverse pregnancy outcomes.


Diflucan labeling

Diflucan Drug Safety Communication (April 26, 2016)

Exparel
(bupivacaine liposome) injection

Local Anesthetic Systemic Toxicity (LAST)

FDA is evaluating the need for regulatory action.

First and second generation antipsychotics

Falls that may result in injury

Updated

The “Warnings and Precautions” section of the labeling for first and second generation antipsychotics was updated February 2017 to include falls that may result in injury.

Example: Symbyax labeling

Kynamro (mipomersen sodium) injection for subcutaneous use

Ineffectiveness of the REMS

The Boxed Warning, “Warnings and Precautions”, “Patient Counseling Information”, “Indications and Usage”, and “Dosage and Administration” sections of the product labeling, as well as the patient Medication Guide, were updated to include information pertaining to appropriate patient selection and monitoring of patients for hepatotoxicity.

Kynamro Labeling
 

Updated

The FDA withdrew approval for Kynamro in the Federal Register effective August 2, 2019.

Withdrawal of Approval

Loperamide hydrochloride capsules, oral solution

Abuse, misuse, and serious cardiac adverse events, including Torsades de Points

Updated

The Boxed Warning, “Adverse Reactions”, and “Warnings and Precautions” sections were updated in November 2016, alerting patients of the risk of Torsades de Pointes and sudden death with the use of higher than recommended dosages of loperamide.  The carton size was reduced, and medication is available in blister packs.

Example: Imodium labeling

Metformin-containing drug products

Hepatitis

Updated

The “Adverse Reactions” section of the labeling for metformin-containing drug products was updated April 2017 to include hepatitis.

Example: Glucophage labeling

Noxafil (posaconazole) injection, extended-release tablets, and oral suspension

Drug interaction between posaconazole and vincristine potentially causing neurotoxicity

Updated

The “Warnings and Precautions, ” “Drug Interactions, ” and “Patient Information” sections of the labeling for Noxafil were updated September 2016 to include the drug interaction between posaconazole and vincristine.

Noxafil labeling

Paregoric oral solution

Labeling error with the potential to cause medication errors

The container label and package insert were revised to clarify the product name, strength, and alcohol content.

Phosphodiesterase (PDE)-5 inhibitors:

  • Adcirca (tadalafil) tablets
  • Cialis (tadalafil) tablets
  • Levitra (vardenafil hydrochloride) orally-disintegrating tablets
  • Revatio (sildenafil citrate) tablets, oral suspension, and injection
  • Staxyn (vardenafil hydrochloride) orally-disintegrating tablets
  • Stendra (avanafil) tablets
  • Viagra (sildenafil citrate) tablets

Skin melanomas

Updated

FDA decided that no action is necessary at this time based on available information.

Ranexa (ranolazine) extended-release tablets

Seizure

Updated

FDA decided that no action is necessary at this time based on available information.

Vascepa (icosapent ethyl) capsules

Liver injury

FDA decided that no action is necessary at this time based on available information.

Velcade (bortezomib) injection for subcutaneous and IV use

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Updated

The “Adverse Reactions” section of the labeling for Velcade was updated June 2017 to include Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Velcade labeling

 

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