Safety & Recalls

The monoclonal antibody had been given an emergency use authorization to treat COVID-19, but the recent spike in cases is driving a shortage in supply.

A total of 16 lots have been recalled.

The bottles have a counterfeit foil seal or label and contain an incorrect number of tablets.

The therapy for HIV-related pneumonia was exposed to cold weather during shipment.

Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.

The agency has stopped enrollment in all ongoing trials.

Angiotensin receptor blockers may be less likely to cause side effects than ACE inhibitors.

Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.

Most of the suspected cases of myocarditis developed after the second dose of the vaccine and were among younger males.

This is being done in coordination with the FDA to address the shortage created by the recall of Chantix. UPDATE: Pfizer has expanded its recall of Chantix from nine lots to 12 lots.

This research sought to understand the relationship of prior medication exposure, existing health conditions, and COVID-19 outcomes using data from the American Heart Association’s COVID-19 Cardiovascular Disease Registry.

An FDA inspection of compound pharmacy Innoveix Pharmaceuticals indicated these lots may not be sterile.

Jardiance lowered risk of hospitalization from acute kidney injury but increased risk of hospitalized from diabetic ketoacidosis compared with a DPP4 inhibitor in one interim analysis.

While the risk of exposure is low, it presents a severe hazard.

The label for the type 2 diabetes treatment has been updated to include the risk of ketoacidosis and damage to the kidney.

The anticancer therapy is now available in 21-count bottles to help accommodate dispensing.

Chances of left ventricular ejection fraction almost disappeared when patient took the ACE-inhibitor lisinopril during treatment with trastuzumab/anthracycline, according to research presented at ASCO.

Immune-related AEs can occur one to two years after treatment, are more common in combination treatments, and can be difficult to manage.