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