FDA News Briefs for Friday, December 21, 2018December 21, 2018
These Food and Drug Administration (FDA) developments came in late this week:
Longer-Acting Pegaspargase Drug Approved for ALL
On December 20, 2018, the FDA approved Asparlas (calaspargase pegol-mknl; Servier Pharmaceuticals), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years. Asparlas provides for a longer interval between doses compared to other available pegaspargase products. More information.
FDA Warning Update: Fluoroquinolone Antibiotics Carry Aortic Aneurysm Risk in Certain Patients
The FDA issued a warning stating that fluoroquinolones should not be prescribed for patients who have an aortic aneurysm or are at risk for an aortic aneurysm unless there are no other treatment options available. The warning is based on new research showing an increased risk of aortic aneurysm or dissection associated with fluoroquinolone use. More information.
Nationwide Recall: Certain Roche CoaguChek Test Strips
Terrific Care LLC. / Medex Supply Dist Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers because these products have been found to inaccurately report high INR test results. More information.