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May 16, 2022
The label for Imbruvica now includes information about the possibility of cardiac failure, which has occurred in 1% of patients. Imbruvica is used to treat B-cell blood cancers.
May 13, 2022
Apokyn and Kynmobi contain apomorphine hydrochloride, which can cause hemolytic anemia that requires hospitalization. The products both treat the loss of muscle movement control caused by Parkinson’s disease.
May 06, 2022
Some children who received GnRH agonists for precocious puberty have experienced a serious side effect known as idiopathic intracranial hypertension, which results in elevated spinal fluid pressure in the brain.
May 05, 2022
The production suspension will impact both the commercial and clinical trial supplies of Lutathera and Pluvicto in the United States and Canada.
May 04, 2022
The FDA has made the labels consistent for combined hormonal contraceptives about the risk these products have to women who have or have had breast cancer.
April 26, 2022
Higher than normal levels of nitrosamine have been detected. Long-term exposure to high amounts of nitrosamine can lead to cancer.
April 18, 2022
Zosyn’s label was updated to warn about the risk of a severe immune response called hemophagocytic lymphohistiocytosis.
April 13, 2022
The label of Triumeq now includes additional information about use in patients who have both HIV and hepatitis B.
Some vials have been found to be missing a label.
April 08, 2022
Two new subsections have been added to the warning and precautious section of Zepzelca’s label to address serious adverse events that were identified during post-market monitoring.
