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FDA News Briefs for Monday, February 25, 2019

February 25, 2019

These Food and Drug Administration (FDA) developments came in last week:

 

FDA Safety Alert:  Febuxostat

The FDA has concluded that there is an increased risk of death with febuxostat compared with allopurinol, 2 drugs that are indicated for the treatment of hyperuricemia. The FDA has added a boxed warning to the febuxostat label warning of this risk. This conclusion was based on an in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with febuxostat. More Information.

 

Recall: ICU Medical ChemoLock Vial Spike

ICU Medical is recalling 1 lot of ChemoLock vial spikes due to the potential for plastic particles to break off the protective cap. In uncommon circumstances, a plastic particle could enter the drug delivery system and be infused into a patient’s intravenous line, which could potentially enter the patient and lead to an embolism. More Information.

 

FDA Warns Against Use of Thermography for Breast Cancer Screening or Diagnosis

The FDA is alerting health care providers and people seeking breast cancer screening that thermography is not an effective alternative to mammography, and should not be used in place of mammography for breast cancer screening or diagnosis.  More Information.