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 (as of September 10, 2018)
Azathioprine tablets Azathioprine sodium injection Imuran (azathioprine) tablets Mercaptopurine tablets Purinethol (mercaptopurine) tablets Purixan (mercaptopurine) oral suspension Uloric (febuxostat) tablets	Drug-drug interaction between thiopurines and febuxostat	FDA is evaluating the need for regulatory action.
Bortezomib for injection Velcade (bortezomib) for injection	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.
Fludeoxyglucose F18 injection Fortamet (metformin hydrochloride) extended-release tablets Glucophage (Metformin Hydrochloride) tablets Glucophage XR (Metformin Hydrochloride) extended-release tablets Glumetza (Metformin Hydrochloride) extended-release tablets Metformin hydrochloride Riomet (Metformin Hydrochloride) oral solution	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. Infuvite Adult Dear Healthcare Provider Letter (5/23/18)
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.
Pomalyst (pomalidomide) capsules Revlimid (lenalidomide) capsules Thalomid (thalidomide) capsules	Solid organ transplant rejection	FDA is evaluating the need for regulatory action.
Repatha (evolocumab) injection	Angioedema	FDA is evaluating the need for regulatory action.
Topamax (topiramate) capsules Topamax (topiramate) tablets Topiramate tablets and capsules	Eye-related adverse events	FDA is evaluating the need for regulatory action.