Drug Safety Communications (Q1 2017)
1. Endo Pharmaceuticals Inc. Issues Voluntary Nationwide Recall for One Lot of Edex® (alprostadil for injection) 10 mcg 2 Pack Carton Due to Potential Lack of Sterility Assurance
Released February 24, 2017
Endo International plc today announced that one of its operating companies, Endo Pharmaceuticals Inc. based in Malvern, Pennsylvania, is voluntarily recalling one lot of Edex® (alprostadil for injection) 10 mcg to the consumer level. This product recall is due to the detection by Endo of a defect in the crimp caps used in the manufacture of the subject product lot.
Edex® (alprostadil for injection) is a prescription only intracavernous injection indicated for the treatment of male erectile dysfunction. The recall applies to the 10 mcg strength, packaged in a 2 pack carton, (NDC 52244-010-02), product lot number 207386, Expiration Date: May 2019 (see photographs of packaged product within). The affected lot was distributed from December 13, 2016 through February 13, 2017 to wholesale distributors and retail pharmacies throughout the United States.
2. Shire - Recall of Kalbitor® (ecallantide)
Released April 12, 2017.
Kalbitor is indicated for the treatment of acute attacks of hereditary angioedema in patients ≥ 12 years of age.
3. FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder
Released March 15, 2017
The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine.