FDA Adds Labeling Supplement to Celebrex After Shown as Safe as Ibuprofen, Naproxen
Posted 29 June 2018 | By
The US Food and Drug Administration (FDA) approved a labeling supplement for Pfizer’s Celebrex (celecoxib) to include the results of a 2016 trial that demonstrated similarity in safety to naproxen and ibuprofen.
The “Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen or Naproxen” (PRECISION) trial began in 2006 with the goal of addressing FDA’s concerns over cardiovascular thrombotic after the risk was linked to both selective and non-selective NSAIDs.
Results from the PRECISION trial
showed that celecoxib, at its lowest approved dosage of twice daily 100mg, has a similar safety profile to ibuprofen and naproxen. At the same low dosage, celecoxib showed little effect on average 24-hour systolic blood pressure (SBP), but ibuprofen dosed in the range of 600 mg to 800 mg three times daily and naproxen dosed in the range of 375 mg to 500 mg twice daily increased average 24-hour SBP.
“Postmarketing safety studies such as the PRECISION trial can add valuable information to our understanding of drug safety issues that emerge in the postmarketing period, and we provide this information to give health care providers a better understanding of the NSAIDs’ drug safety profile,” FDA said in a statement
, issued Thursday.
FDA cautioned not enough trial subjects received higher doses of Pfizer’s Celebrex to evaluate the risk of cardiovascular events.
CDER Statement: FDA Approves Labeling Supplement for Celebrex (celecoxib)