FDA approved adding the results of the PRECISION cardiovascular outcomes trial to Pfizer Inc.'s Celebrex (celecoxib) label, while emphasizing that it is the lowest approved dose of Celebrex that was shown to have comparable CV risk to moderate doses of naproxen and ibuprofen.
Addition Of Celebrex PRECISION Cardiovascular Trial to Label Emphasizes Use Of Lowest Dose
Heeding concerns of an advisory panel, US agency underscores that it is the lowest approved dose of the COX-2 inhibitor that has comparable CV risk to moderate doses of ibuprofen and naproxen.
More from Drug Safety
• By
The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
• By
Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.
• By
The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.
• By
The Pink Sheet Drug Review Profile breaks down the FDA's long reckoning with testosterone cardiovascular safety concerns