Recalls and label changes
A label change on omalizumab (Xolair) warning of a slightly elevated risk of cardiovascular and cerebrovascular serious adverse events. Events observed in a 5-year safety study included transient ischemic attacks; heart attacks; sudden, unexpected chest pain; pulmonary hypertension; and blood clots in the lungs and veins. A follow-up analysis of 25 trials did not confirm the risks, but data limitations prevented the FDA from making any definitive conclusions. Trials have also shown mixed results on an association with cancer, the agency said. Clinicians should periodically reassess patients' need for continued therapy with the drug.
A recall of 1 lot of heparin sodium by Hospira, (1,000 USP heparin units/500 mL in 0.9% sodium chloride injection, 500 mL) due to a confirmed customer report of particulate in a single unit.
A recall of all compounded sterile preparations by Martin Avenue Pharmacy after a recent FDA inspection found quality control procedures that present a risk to sterility assurance.
A recall of 4 product lots from Pharmacy Creations after testing results indicated the potential of nonsterility.
A recall of the craniomaxillofacial distraction system by DePuy Synthes because the device may reverse direction and lose the desired distraction distance after surgery.
NephroCheck, a laboratory test to determine if critically ill patients are at risk for moderate to severe acute kidney injury (AKI). The test detects the presence of insulin-like growth-factor binding protein 7 and tissue inhibitor of metalloproteinases in the urine. Within 20 minutes, the test provides a score based on the amount of proteins present that correlates to the patient's risk of developing AKI within 12 hours. Effectiveness is based on 2 clinical studies comparing AKI diagnoses in 500 critically ill subjects to the new test's results. It accurately detected 92% of AKI patients in 1 study and 76% in the other, but it gave a false positive result in about half of patients without AKI in both studies.
T2Candida, the first direct blood test for 5 yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata, and Candida krusei. The test can identify the pathogens from a single blood specimen within 3 to 5 hours. Effectiveness was based on 1 study of 1,500 samples in which the test correctly categorized nearly 100% of the negative specimens, and 1 study of 300 blood samples in which the test correctly identified the organism in 84% to 96% of the positive specimens. Because yeast bloodstream infections are uncommon, and because false positive results are possible, physicians should perform blood cultures to confirm results.
Naloxegol (Movantik), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain. Safety and effectiveness were established in trials of more than 1,000 patients in which 44% of those receiving 25 mg and 41% of those receiving 12.5 mg had an increase in bowel movements per week, compared to 29% on placebo. Common side effects include abdominal pain, diarrhea, and headache.
Dulaglutide (Trulicity), a glucagon-like peptide-1 (GLP-1) receptor agonist, to treat type 2 diabetes. Safety and effectiveness of this once-weekly subcutaneous injection were evaluated in 6 clinical trials with 3,342 patients in which it reduced HbA1c levels. It was studied as a stand-alone therapy and in combination with other therapies. It should not be used to treat type 1 diabetes or diabetic ketoacidosis, in patients with severe stomach or intestinal problems, or as first-line therapy. The most common side effects are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite. It has a boxed warning that thyroid C-cell tumors have been observed in rodents but it is unknown whether the drug causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. It should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2. The FDA is requiring several postmarketing studies, including trials in patients with renal impairment and increased cardiovascular risk.