Tag Archive for: patient safety

Citing America’s Poison Centers, which represents 55 regional poison centers across the U.S., Reuters revealed that all three incidences of hypoglycemia were detected by the same regional poison control center and that the FDA was investigating these reports.

The agency stated that companies will be required to add a serious warning on the prescribing information for cancer therapies known as CAR-T, made by Gilead Sciences, Johnson & Johnson, Novartis and others.

The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.

The European Union’s drug regulator will this week consider wider use of Novo Nordisk’s weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks.

The current unmet needs in the female contraceptives market are similar to those that were present 10 years ago, according to GlobalData.

In its announcement, the Boston, MA–based company said that the deaths were “unrelated” to the study treatment and that the study pause was “protocol-specified.”

The Dutch medical devices maker started the recall process on Nov. 30 this year and has recalled 150 devices in the United States.

The World Health Organization on Thursday said several contaminated syrups and suspension medicines had been identified in countries in the WHO regions of the Americas, the Eastern Mediterranean, South-East Asia and the Western Pacific.

The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.

The move follows a review that started in July and covered a range of drugs known as GLP-1 receptor agonists, also including Eli Lilly’s Trulicity, Sanofi’s Suliqua, AstraZeneca’s Bydureon and Novo’s Rybelsus and Saxenda.