July - September 2020 | 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 January 31, 2025) |
|---|---|---|
Actemra (tocilizumab)
| Hepatitis B reactivation |
Updated
FDA determined that no action is necessary at this time based on available information. |
Alcohol containing hand sanitizers
| Blood methanol induced blindness and death | Regulatory actions taken. For additional details, refer to: www.fda.gov/handsanitizerlist
|
Aubagio (teriflunomide) Generic products containing teriflunomide | Nail disorder |
Updated
The “Adverse Reactions” section of the labeling was updated in April 2021 to include nail psoriasis. Example: Aubagio labeling |
Aubagio (teriflunomide) Generic products containing teriflunomide | Tooth disorder |
Updated
FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor the issue. |
Benadryl (diphenhydramine) Generic products containing diphenhydramine hydrochloride
| Drug abuse and dependence | FDA decided that no action is necessary at this time based on available information. FDA Drug Safety Communication (9/24/2020)
|
Bosulif (bosutinib monohydrate) Gleevec (imatinib mesylate) Generic drugs containing imatinib mesylate | Facial paralysis | FDA decided that no action is necessary at this time based on available information. |
Cyklokapron (tranexamic acid) injection Generic products containing tranexamic acid | Wrong route of administration error (inadvertent intrathecal administration instead of recommended intravenous administration) | The prescribing information was updated to include the risk of medication errors due to incorrect route of administration. The carton and container labeling was also revised to highlight the recommended intravenous route of administration. FDA Safety Communication to Healthcare Providers (12/3/2020)
|
Darzalex (daratumumab)
Updated
Darzalex Faspro (daratumumab, hyaluronidase-fihj)* | Ocular toxicity
|
Updated
The “Warnings and Precautions”, and “Patient Counseling Information” sections of the labeling were updated in January 2022 to include information about ocular toxicity. *An administrative error resulted in the omission of Darzalex Faspro from this signal and was added after the initial quarterly report was posted. |
| Entyvio (vedolizumab) | Pancreatitis |
Updated
The “Adverse Reactions” section of the labeling was updated in August 2021 to include pancreatitis. |
Finasteride Plus 1.25mg capsules (compounded drug)
Minoxidil (compounded drug) | Cardiac effects related to undeclared or higher than labeled dose of minoxidil that include tachycardia, low blood pressure, and salt and water retention causing swelling | Voluntary recall |
Updated
Metronidazole oral and intravenous* Helidac Therapy (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride)** Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride)** Generic products containing metronidazole (oral and intravenous) | Torsade de pointes/ QT prolongation
|
Updated
The “Precautions” and “Adverse Reactions” sections of the labeling for oral and intravenous metronidazole products were updated in March 2021 to include QT-prolongation. Example: Pylera labeling *Product names updated for clarity. **An administrative error resulted in the omission of Helidac and Pylera from this signal and were added after the initial quarterly report was posted. |
Otezla (apremilast) Generic products containing apremilast | Hypersensitivity |
Updated
The “Warnings and Precautions” and “Patient Counseling Information” sections of the labeling were updated in December 2021 to include information about hypersensitivity. Example: Otezla labeling |
| Polidocanol (compounded drug) | Product Compounding Quality |
Updated
FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor this issue. |
Proton Pump Inhibitors
| Rhabdomyolysis |
Updated
FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor this issue. |
Rinvoq (upadacitinib)
| Hypersensitivity
|
Updated
The “Warnings and Precautions” section of the labeling was updated in January 2022 to include information about hypersensitivity reactions. |
Teflaro (ceftaroline fosamil)
| Neurotoxicity | The “Warnings and Precautions,” “Adverse Reactions” and “Patient Counseling Information” sections of the labeling for Teflaro were updated November 2020 to include neurological adverse reactions.
|
| Testosterone Pellets (compounded drug) | Breast Cancer | FDA decided that no action is necessary at this time based on available information. |
Zinacef (cefuroxime sodium) Ceftin (cefuroxime axetil) Generic products containing cefuroxime | Kounis syndrome (Acute myocardial ischemia with or without myocardial infarction that may occur as part of an allergic reaction)
|
Updated
The “Adverse Reactions” section of the labeling was updated between March 2021 and May 2021 to include acute myocardial ischemia with or without myocardial infarction that may occur as part of an allergic reaction. Example: Zinacef labeling |
Zyvox (linezolid) Generic products containing linezolid | Inappropriate antidiuretic hormone secretion |
Updated
The “Warnings and Precautions”, and “Adverse Reactions” sections of the labeling were updated in October 2021 to include inappropriate antidiuretic hormone secretion. Example: Zyvox labeling |