April - June 2018 | 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 |
|---|---|---|
| Drug-drug interaction between thiopurines and febuxostat |
Updated
The “Precautions: Drug Interactions” section of the azathioprine labeling was updated in December 2018 to include the drug-drug interaction between thiopurines and xanthine oxidase inhibitors, including febuxostat. Example: Imuran labeling
|
| Thrombotic microangiopathy |
Updated
The “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling Information” sections of the bortezomib labeling were updated in April 2019 to include thrombotic microangiopathy. |
| Bunavail (buprenorphine and naloxone) buccal film | Product quality issues leading to opioid withdrawal symptoms |
Updated
FDA determined that no action is necessary at this time based on available information. |
| Laboratory interference (false positive and false negative positron emission tomography (PET) scans) |
Updated
FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor the issue. |
| Infuvite Adult (multiple vitamins) injection | Medication Error: Incorrect strength presentation | FDA decided that no action is necessary at this time based on available information. |
| Insulin Pen Products | Wrong dose errors and other safety concerns associated with pharmacies opening cartons to dispense a single insulin pen |
Updated
The “How Supplied/Storage and Handling” section of the insulin pen products labeling was updated in November 2019 to advise prescribers to “Dispense in the original sealed carton with the enclosed Instructions for Use.” Example: Lantus (insulin glargine injection) labeling FDA clarified the intent of the November 2019 labeling revisions in October 2020.
|
| Kynamro (mipomersen sodium) injection | Angioedema |
Updated
The “Contraindications”, Warnings and Precautions”, and “Patient Counseling Information” sections of the Kynamro labeling were updated in March 2019 to include angioedema. The Kynamro applicant notified FDA that the drug product was no longer marketed and requested that approval of the application be withdrawn. FDA withdrew approval for Kynamro in August 2019. |
| Methimazole tablets | Vasculitis |
Updated
The “Warnings”, “Precautions”, and “Adverse Reactions” sections of the methimazole labeling were updated in January 2019 to include vasculitis. |
| Myalept (metreleptin) for injection | Wrong dose errors associated with small (<1 mL) injection volumes |
Updated
The “Dosage and Administration”, “Adverse Reactions”, “Overdosage”, “Patient Counseling Information”, and “Instructions for Use” sections of the labeling were updated in December 2019 to include information regarding medication errors in pediatric patients using small volumes. Additional information included example doses and volumes by weight as well as volume conversions for patients using insulin syringes. |
| Natpara (parathyroid hormone) for injection | Seizures |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the Natpara labeling were updated in December 2018 to include seizures. |
| Natpara (parathyroid hormone) for injection | Hypotension |
Updated
FDA decided that no action is necessary at this time based on available information. |
| Orencia (abatacept) injection | Psoriasis |
Updated
The “Adverse Reactions” section of the Orencia labeling was updated in March 2019 to include new or worsening psoriasis. |
| Solid organ transplant rejection |
Updated
The “Adverse Reactions” section of the pomalidomide, lenalidomide, and thalidomide labeling was updated between June 2019 and October 2019 to include solid organ transplant rejection. |
| Repatha (evolocumab) injection | Angioedema |
Updated
The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the Repatha labeling were updated in October 2018 to include angioedema. |
| Eye-related adverse events |
Updated
The “Warnings and Precautions” section of the labeling was updated June 2021 to include myopia, mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. |