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  6. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April - June 2018
  1. Surveillance: Post Drug-Approval Activities

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April - June 2018

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April - June 2018

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.