FDA Warns Prolia May Cause Severe Low Blood Calcium Levels
The FDA began investigating a link between side effects of Prolia and hypocalcemia in November 2022, following adverse reports from dialysis patients.
The FDA began investigating a link between side effects of Prolia and hypocalcemia in November 2022, following adverse reports from dialysis patients.
The deal seeks to prevent Amgen from leveraging its near-monopoly on Tepezza and other Horizon drugs into an overwhelming competitive advantage.
Acquiring Tepezza and Krystexxa would give Amgen a monopoly on those treatments, which it could then use to smother competition, the FTC warns
Plaintiffs say Horizon has failed to share key financial projections to shareholders of what will likely happen if Amgen buys Tepezza manufacturer Horizon Therapeutics
Amgen agreed to buy Horizon as it faces unknown liability from Tepezza lawsuits over hearing loss suffered by users of the thyroid eye disease drug
Prolia side effects may increase the risk of dangerously low calcium levels in the blood of individuals undergoing dialysis treatment, according to interim findings of an ongoing study
The findings support previous studies which have linked Prolia discontinuation to an increased risk in bone fractures, though this is one of the first cases detected in a bone cancer patient.