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 |
Updated
FDA decided that no action is necessary at this time based on available information. |
| Adempas (riociguat) tablets | Syncope | FDA decided that no action is necessary at this time based on available information. |
| Somnambulism, Abnormal Sleep-related event |
Updated
The “Boxed Warning”, “Contraindications”, “Warnings”, “Precautions”, “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in February 2019 and August 2019 to include information about complex sleep behaviors. Example: Ambien labeling An FDA Drug Safety Communication was issued on April 30, 2019. |
| Thrombotic microangiopathy |
Updated
The “Adverse Reactions” section of the labeling was updated between August 2018 and November 2018 to include thrombotic microangiopathy. Example: Bosulif labeling |
| Bridion (sugammadex) injection | Labeling confusion - total strength expression on vial obscured by peel-off sticker intended for syringe |
Updated
The Bridion applicant revised the peel-off label by moving it from the principal display panel to the side panel and vertically repositioned the barcode. |
| Bridion (sugammadex) injection | Laryngospasm |
Updated
FDA decided that no action is necessary at this time based on available information. |
| Bridion (sugammadex) injection | Bronchospasm |
Updated
FDA decided that no action is necessary at this time based on available information. |
| Hypersensitivity and anaphylaxis | The “Warnings” and “Adverse Reactions” sections of labeling were updated to include hypersensitivity reactions. Carnitor labeling |
Insulin Pen Products
| Product use error – failure to remove inner needle cover |
Updated
An FDA Safety Communication was issued on September 27, 2018, cautioning patients, caregivers, and health care providers when using pen needles to inject medicines. |
| 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. Kinevac labeling |
| Lamictal (lamotrigine) tablets | Hemophagocytic lymphohistocytosis (HLH) | The “Warnings and Precautions” section of labeling has been updated to include hemophagocytic lymphohistocytosis. Lamictal labeling Lamictal Drug Safety Communication (April 25, 2018) |
| 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 |
Updated
The “Adverse Reactions” section of the posaconazole labeling was updated in February 2019 to include pseudoaldosteronism. For itrazonazole, FDA decided that no action is necessary at this time based on available information. |
| Propylthiouracil tablets | Fatal cases of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis |
Updated
The “Warnings,” “Precautions,” “Adverse Reactions,” and “Medication Guide” sections of the propylthiouracil labeling were updated in September 2018 to include vasculitis. |
| Infusion related and hypersensitivity reactions |
Updated
The Varubi applicant issued a Dear Health Care Provider letter to inform health care providers of the potential risk of anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions associated with use of Varubi (rolapitant) injectable emulsion. Dear Health Care Provider letter The Varubi applicant notified FDA that Varubi injectable emulsion was no longer marketed and requested that approval of the Varubi injectable emulsion application be voluntarily withdrawn. FDA withdrew approval for Varubi in the Federal Register effective January 22, 2021. |
| Volumen (barium sulfate) | Name confusion with Voluven (hydroxyethyl starch) |
Updated
The Volumen manufacturer issued an information letter on February 14, 2018, to inform their customers of the potential risk of name confusion. The proprietary name was changed from Volumen to Neulumex to address the risk of name confusion. |