October - December 2016 Report | 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 April 16, 2020)
Contrave (naltrexone HCl and bupropion HCl) extended-release tablets	Loss of consciousness	FDA is evaluating the need for regulatory action.
Coumadin (warfarin sodium) tablets, for oral use Eliquis (apixaban) tablets, for oral use Pradaxa (dabigatran etexilate mesylate) capsules, for oral use Savaysa (edoxaban tosylate) tablets, for oral use Xarelto (rivaroxaban) tablets, for oral use	Menorrhagia	FDA decided that no action is necessary at this time based on available information.
Depo-Medrol (methylprednisolone acetate) injectable suspension, USP, not for use in neonates, contains benzyl alcohol intravenous use Depo-Provera (medroxyprogesterone acetate), injectable suspension, USP Depo-Provera CI (medroxyprogesterone acetate), injectable suspension, for intramuscular use	Medication errors	The carton and container labeling were revised to help differentiate between Depo-Medrol and Depo-Provera products. Depo-Provera labeling
Diabeta (glyburide) tablets, USP	Skin reactions	The “Adverse Reactions” section of the labeling for Diabeta was updated to include bullous reactions, erythema multiforme, and exfoliative dermatitis. Diabeta labeling
Imbruvica (ibrutinib), capsules, for oral use	Pneumocystis jirovecii pneumonia (PJP)	The “Warnings and Precautions” section of the labeling for Imbruvica was updated to include PJP. Imbruvica labeling
Nitropress (sodium nitroprusside) injection	Carboxyhemoglobinemia	Updated FDA decided that no action is necessary at this time based on available information.
Northera (droxidopa) capsules, for oral use	Cerebrovascular accident	The “Warnings and Precautions” section of the labeling for Northera was updated to include information about stroke. The “Adverse Reactions” section of the labeling for Northera was updated with information about cerebrovascular accident. Northera labeling FDA is evaluating the need for other regulatory action.
Nucala (mepolizumab) for injection, for subcutaneous use	Anaphylaxis	The “Warning and Precautions” section of the labeling for Nucala was updated to include anaphylaxis. Nucala labeling
Opsumit (macitentan) tablets, for oral use	Fluid overload	The “Warnings and Precautions” section of the labeling for Opsumit was updated to include information about fluid retention. Opsumit labeling
Otezla (apremilast) tablets, for oral use	Diarrhea, nausea, and vomiting	Updated The “Warnings and Precautions” and “Patient Counseling Information” sections of the Otezla labeling were updated June 2017 to include diarrhea, nausea, and vomiting. Otezla labeling
Tanzeum (albiglutide) for injection, for subcutaneous use	Use errors with the Tanzeum pen	FDA is evaluating the need for regulatory action.