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 December 13, 2022)
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	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
Bortezomib for injection Velcade (bortezomib) for injection	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. Velcade labeling
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	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. Kynamro labeling 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. Withdrawal of Approval
Methimazole tablets	Vasculitis	Updated The “Warnings”, “Precautions”, and “Adverse Reactions” sections of the methimazole labeling were updated in January 2019 to include vasculitis. Methimazole labeling
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	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the Natpara labeling were updated in December 2018 to include seizures. Natpara labeling
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. Orencia labeling
Pomalyst (pomalidomide) capsules Revlimid (lenalidomide) capsules Thalomid (thalidomide) capsules	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. Pomalyst labeling Revlimid labeling Thalomid labeling
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. Repatha labeling
Topamax (topiramate) capsules Topamax (topiramate) tablets Topiramate tablets and capsules	Eye-related adverse events	FDA is evaluating the need for regulatory action.