Public Citizen Asks US FDA To Ban Olmesartan Hypertension Medicines

Given risk of serious gastrointestinal disorder, Public Citizen argues there is no reason to keep the drugs on the market when so many alternative treatments are available .

Risk Dial

Four years after the US FDA issued a warning that blood pressure drugs containing olmesartan can cause a severe gastrointestinal disorder, Public Citizen is calling on the agency to remove them from the market.

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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.

Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing

 

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.

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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.

Testosterone CV Safety, From Signal To Label

 

The Pink Sheet Drug Review Profile breaks down the FDA's long reckoning with testosterone cardiovascular safety concerns

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CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers

 

One CDRH employee said the cuts already are having a major effect on morale.

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.