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 |
FDA is evaluating the need for regulatory action.
|
|
Thrombotic microangiopathy |
FDA is evaluating the need for regulatory action. |
Bunavail (buprenorphine and naloxone) buccal film |
Bunavail (buprenorphine/naloxone buccal film) product quality issues leading to opioid withdrawal symptoms |
FDA is evaluating the need for regulatory action. |
|
Laboratory interference (false positive and false negative positron emission tomography (PET) scans) |
FDA is evaluating the need for regulatory action. |
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 |
FDA is evaluating the need for regulatory action.
|
Kynamro (mipomersen sodium) injection |
Angioedema |
FDA is evaluating the need for regulatory action. |
Methimazole tablets |
Vasculitis |
FDA is evaluating the need for regulatory action. |
Myalept (metreleptin) for injection |
Wrong dose errors associated with small (<1 mL) injection volumes |
FDA is evaluating the need for regulatory action. |
Natpara (parathyroid hormone) for injection |
Seizures |
FDA is evaluating the need for regulatory action. |
Natpara (parathyroid hormone) for injection |
Hypotension |
FDA is evaluating the need for regulatory action. |
Orencia® (abatacept) injection |
Psoriasis |
FDA is evaluating the need for regulatory action.
|
|
Solid organ transplant rejection |
FDA is evaluating the need for regulatory action. |
Repatha (evolocumab) injection |
Angioedema |
FDA is evaluating the need for regulatory action. |
|
Eye-related adverse events |
FDA is evaluating the need for regulatory action. |