Rigorous Detection of Nitrosamine Contaminants in Metformin Products: Balancing Product Safety and Product Accessibility

Since 2018, multiple drug products, including angiotensin receptor blockers (ARBs), histamine blocker ranitidine (commonly known as Zantac), have been recalled due to the presence of nitrosamines at unacceptable amounts

  • CDER scientists have developed and publicly shared gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-MS (LC-MS) technologies
  • For detecting and quantifying up to eight different nitrosamines  at levels below acceptable U.S. intake limit for the nitrosaminat low levels


Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) 

Implanted SCS are an aid to cope with unmanageable, chronic chronic pain

  • However, FDA continues to receive reports of associated serious side effects

Health care providers should conduct a trial stimulation period with patients to confirm satisfactory pain relief before implanting a spinal cord stimulator (SCS)

  • Implant only in patients who have passed stimulation trial performed for 3-7 days showing 50% percent reduction in pain symptoms.
  • Discuss the benefits and risks of the different types of implants and other treatment options with patients
  • Several other recommendations


Tanning Beds and Booths

Tanning beds and booths are sunlamp products used for indoor UV skin tanning

  • Risk of fire due to improper maintenance, dirty air filters blocking air flow, incompatible parts, failure to perform servicing and maintenance
  • Owners and operators should perform maintenance recommended by product manufacturers to reduce risk of smoke and fire
  • FDA monitoring adverse event reports and will keep public informed


New Rule on Reporting Requirements for Right to Try Act

Right to Try Act provides pathway for patients with life-threatening diseases who have tried all approved treatment options and who are unable to participate in a clinical trial, to access certain unapproved treatments

  • Sponsor or manufacturer of drug/biologic is responsible for determining whether to make their product available to patients who qualify
  • New statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA


Labeling Changes Regarding Naloxone

Naloxone can be administered by individuals with or without medical training to help reduce opioid overdose deaths

  • Required labeling changes recommend health care professionals prescribe naloxone when they prescribe medicines to treat OUD
  • Also, they consider prescribing naloxone to patients being prescribed opioid pain medicines who are at increased risk of opioid overdose


Image credit: FDA