January - March 2018 | Potential Signals of Serious Risks/New Safety Information Identified from 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 |
---|---|---|
|
Albuterol sulfate and serious skin reactions |
FDA decided that no action is necessary at this time based on available information. |
|
IL-1 and IL-6 inhibitors and pulmonary hypertension, interstitial lung disease, pulmonary alveolar proteinosis |
FDA is evaluating the need for regulatory action. |
Adempas (riociguat) tablets |
Syncope |
FDA decided that no action is necessary at this time based on available information. |
|
Somnambulism, Abnormal Sleep-related event |
FDA is evaluating the need for regulatory action. |
Volumen (barium sulfate) |
Name confusion with Voluven (hydroxyethyl starch) |
FDA is evaluating the need for regulatory action. |
|
Thrombotic microangiopathy |
FDA is evaluating the need for regulatory action. |
Bridion (sugammadex) injection |
Labeling confusion - total strength expression on vial obscured by peel-off sticker intended for syringe |
FDA is evaluating the need for regulatory action. |
Bridion (sugammadex) injection |
Laryngospasm |
FDA is evaluating the need for regulatory action. |
Bridion (sugammadex) injection |
Bronchospasm |
FDA is evaluating the need for regulatory action. |
|
Hypersensitivity and anaphylaxis |
The “Warnings” and “Adverse Reactions” sections of labeling were updated to include hypersensitivity reactions. |
Insulin Pen Products
|
Product use error – failure to remove inner needle cover |
FDA is evaluating the need for regulatory action. |
Kinevac (sincalide) for injection |
Anaphylaxis, anaphylactic shock, and other hypersensitivity reactions |
The “Contraindications,” “Warnings,” and “Adverse Reactions” sections of labeling were updated to include anaphylaxis and hypersensitivity reactions. |
Lamictal (lamotrigine) tablets |
Hemophagocytic lymphohistocytosis (HLH) |
The “Warnings and Precautions” section of labeling has been updated to include hemophagocytic lymphohistocytosis. |
Ninlaro (ixazomib) capsules |
Product packaging quantity issues (empty unit dose blister cells) |
FDA decided that no action is necessary at this time based on available information. |
|
Mineralocorticoid excess |
FDA is evaluating the need for regulatory action. |
Propylthiouracil tablets |
Fatal cases of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis |
FDA is evaluating the need for regulatory action. |
|
Infusion related and hypersensitivity reactions |
FDA is evaluating the need for regulatory action. |