Tag Archive for: patient safety

Syfovre has been linked to rare cases of eye inflammation that could lead to blinding, though Apellis’ review so far has found no connection between the treatment and the complications.

Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space

The U.S. Department of Justice asked the U.S. Supreme Court to stop Purdue Pharma from proceeding with a bankruptcy settlement that protects its Sackler family owners from lawsuits.

The Medicines and Healthcare products Regulatory Agency said AstraZeneca’s GLP-1 drug for type 2 diabetes, called exenatide and marketed as Bydureon, was also included in the review.

The WHO flagged contamination with unacceptable amounts of diethylene glycol and ethylene glycol, which are toxic to humans when consumed and can prove fatal, in samples taken from a batch of cough syrup made by QP Pharmachem.

While six of the fatalities were deemed “unlikely or unrelated to the study drug,” the company nevertheless elected to suspend the entry of patients into the study.

Soaring demand from Americans seeking to lose weight has reduced the pressure from investors on Novo Nordisk to deliver strong results in its trial to test whether the drug also has medical benefits.

The U.S. health regulator said it had received reports of pediatric and adult patients suffering burn injuries when the tools, sold under the brand names MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, were used on them.

The move comes after a review of data of 40 patients in the trial indicated potentially excessive respiratory-related events, including seven deaths and five serious adverse events.

The European Medicines Agency (EMA) is probing Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland’s health regulator flagged three cases of patients on the drugs thinking about suicide or self-harm.