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  6. October - December 2016 Report | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. FDA's Adverse Event Reporting System (FAERS)

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 October 25, 2023)

Contrave (naltrexone HCl and bupropion HCl) extended-release tablets

Loss of consciousness

Updated

The “Adverse Reactions” section of the labeling was updated in May 2017 to include loss of consciousness.

Contrave labeling

  • 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

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

Updated

GlaxoSmithKline LLC requested the voluntary revocation of the biologics license application for Tanzeum (albiglutide) for injection and the revocation was effective October 23, 2020.

 

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