Recalls, alerts, warnings
A warning not to prescribe eluxadoline (Viberzi) to patients without gallbladders, who have an increased risk of developing serious pancreatitis when taking the drug. The drug, which is used to treat irritable bowel syndrome with diarrhea, has been associated with at least 120 reports of severe pancreatitis since it was first approved in May 2015. Seventy-six of these cases resulted in hospitalization, and two deaths were reported (one associated with pancreatitis, the other with sphincter of Oddi spasm). Serious pancreatitis or death has occurred in this patient population after only one or two doses.
A class I recall of SynchroMed II and SynchroMed EL implantable drug infusion pumps because a software issue may cause unintended drug delivery during a priming bolus procedure and reduced delivery afterward. This can result in overdose or underdose. The pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity. The manufacturer in October 2016 began replacing software application cards with updated cards for affected consumers.
A recall of all unexpired sterile injectable products labeled “latex free” produced at Advanced Pharma, Inc.'s Houston location between Sept. 1, 2016, and Feb. 16, 2017, because they may contain synthetic and/or natural latex. Products were distributed to health care facilities and not directly to patients. No related adverse events have been reported.
A safety alert about Transvascular Autonomic Modulation (TVAM), an experimental procedure that uses balloon angioplasty devices outside the scope of FDA-approved indications. Although at least one physician has claimed that TVAM can treat the signs and symptoms of autonomic dysfunction in multiple neurological disorders, the procedure has not been formally studied in clinical trials.
Expanded use of the Vidas Brahms procalcitonin (PCT) assay to help clinicians determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections and stopped in patients with sepsis. Intended to be used in the hospital or ED, the test is the first to use PCT as a biomarker to help clinicians make antibiotic management decisions in these patients. The test was originally approved to help clinicians predict a patient's risk of dying or becoming sicker due to sepsis. Its expanded use follows data from randomized clinical trials showing a significant decrease in antibiotic use for patients who had received PCT-guided therapy versus standard therapy. Although patients' safety was not significantly affected in studies, risks include false-positive and false-negative results.
Marketing of the PhenoTest BC Kit, the first test to identify organisms that cause bloodstream infections and provide information about antibiotic sensitivity. The test, performed on the Pheno System, can identify 14 species of bacteria and two species of yeast that cause bloodstream infections, provide antibiotic sensitivity information on 18 antibiotics for a subset of the identified organisms, and identify the presence of two indicators of antibiotic resistance. Results obtained from a positive blood culture are provided in about 90 minutes, and additional information that can help guide treatment recommendations is provided in about 6.5 hours. In a clinical study of 1,850 positive blood cultures, the test correctly identified the organisms more than 95% of the time, and antibiotic sensitivity results were also accurate when compared to traditional tests. Risks include false-positive findings.
Telotristat ethyl (Xermelo) tablets, in combination with somatostatin analog (SSA) therapy, to treat adults with carcinoid syndrome diarrhea that is inadequately controlled with SSA therapy alone. The drug, which reduces the frequency of diarrhea by inhibiting the production of serotonin by carcinoid tumors, is approved to be taken orally three times daily with food. The drug received designation as an orphan drug and was granted fast-track designation and priority review. In a 12-week randomized controlled trial of 90 adults with well-differentiated metastatic neuroendocrine tumors and carcinoid syndrome diarrhea, 33% of those randomized to add the drug to their SSA regimen had an average reduction of two bowel movements per day, compared to 4% of those randomized to placebo. The most common side effects include nausea, headache, increased levels of gamma-glutamyl transferase, depression, peripheral edema, flatulence, decreased appetite, and fever. Risk of constipation may be increased in patients who have fewer than four bowel movements per day, and clinicians should monitor patients for severe constipation.
Safinamide (Xadago) tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing an increase in symptoms (aka “off” time). In a trial of 645 participants, those who received the add-on drug versus placebo experienced a reduction in “off” time and more beneficial times of symptom control (aka “on” time). Another trial of 549 participants showed that, compared to those who received placebo, those who received the drug had more “on” time and better motor function scores during “on” time than before the treatment was added. The most common adverse reactions were uncontrolled involuntary movement, falls, nausea, and insomnia.