News: Recalls (ZINBRYTA, ALKA-SELZER), Warning (OPTERNATIVE) – Drug and Device Digest


FDA working with manufacturers to withdraw Zinbryta from market

 Zinbryta approved in 2016

  • Relapsing forms of multiple sclerosis

Biogen and partner AbbVie voluntarily withdrawing  marketing application globally

  • Reported cases of encephalitis and meningoencephalitis
  • Nature/complexity of adverse events affects and limited number of patients being treated prevents adequate characterization of evolving benefit/risk profile
  • Withdrawal in the best interest of patients

Working closely with FDA and global regulatory authorities on  withdrawal timelines 

  • European Medicines Agency announced recall following 12 reports of serious inflammatory brain disorders worldwide



Bayer’s voluntary recall of Alka-Seltzer Plus products due to labeling errors

Recall due to labeling errors

  • Ingredients listed on carton front sticker may be different from back AND product in carton
  • May lead consumers to ingest ingredient to which they are allergic to or  ciuld have serious health consequences




Warning Letter: OPTERNATIVE Eye Examination Mobile Medical App 

Product is ‘device’

  • Intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body

Violation of the Federal Food, Drug, and Cosmetic Act 

  • FDA review of website
  • ADULTERATION: No approved application for premarket approval
  • MISBRANDING: No FDA notification of intent to commercialize

2016 FDA meeting on regulatory requirements

  • Meeting with Office of Compliance and Office of Device Evaluation
  • Requirement of premarket submission to evaluate safety and effectiveness

If failure of prompt action to correct violations

  • FDA initiated action without further notice
  • Seizure, injunction, civil money penalties


Image credits: FDA, Biogen, Opternative


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