FDA Calls for Restrictions on Ovarian Cancer Drug Rubraca Due to High Mortality Rates
The FDA is seeking restrictions on the ovarian cancer drug Rubraca, following data indicating it may increase the risk of death in some patients.
Tag Archives: Drug Side Effects
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Study Highlights Link Between Tepezza and Hearing Problems After Four Injections of the Thyroid Eye Disease Drug
A new study finds that most Tepezza patients suffer some degree of hearing loss, and a third of those may not recover their hearing.
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Copiktra Side Effects Too Dangerous for Some Cancer Patients, FDA Advisory Committee Decides
An FDA advisory committee voted to recommend the agency not approve Copiktra for some blood cancer patients due to an increased risk of death.
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FDA Issues New Draft Guidance on Children’s Use in Clinical Trials
The FDA has proposed new guidelines for safely including children in clinical trials.
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Cancer Drug Copiktra Could Shorten Life Expectancy in Some Patients, FDA Reviewers Warn
An advisory committee is being asked to review the benefits and risks of Copiktra, a blood cancer drug FDA experts say appears to lower life expectancy in some cancer patients.
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High-Dose Glucocorticoids Useful in Treating Stevens-Johnson Syndrome: Study
A new Chinese study found glucocorticoids are effective treatments for Stevens-Johnson Syndrome.
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Fosamax Fracture Lawsuits Dismissed Again, After Judge Rules FDA Rejected Label Warning Change
A federal judge has ruled that hundreds of Fosamax femur fracture lawsuits are preempted by federal law because the FDA rejected a proposed warning label change.
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Neptazane Linked to Stevens-Johnson Syndrome (SJS) Risk In New Case Study
A case study links the glaucoma drug Neptazane with a case of Stevens-Johnson Syndrome, a serious skin reaction which can lead to severe injury, hospitalization and death.
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FDA Guidance Seeks to Speed Up Approval of Generic Drugs
The FDA has issued new guidance on how to speed up generic drug approval processes, amid existing concerns that the agency already approves many generic drugs too quickly and without…
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FDA’s REMS Drug Safety Program Sometimes Confusing To Patients, And A Barrier To Drug Access: Study
A new study finds that many patients are confused by the FDA's REMS drug safety program, which adds extra requirements to drugs with potentially severe side effects.
