Recalls, warnings and label changes
A recall of Puritan Bennett 840 Series ventilators by Covidien due to a software problem that may trigger a diagnostic code causing the ventilator to stop functioning. This issue may cause serious adverse health consequences, including death. A software update to correct the problem is available online.
A recall of calcium gluconate 10% injections by Rx Formulations due to a risk of microbial contamination, after FDA testing identified gram-positive rod bacteria in the product.
A recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump by Tandem Diabetes Care, because the cartridges may be at risk for leaking, which could potentially result in the device delivering too much or too little insulin.
A recall of the Trufill n-BCA Liquid Embolic System by Codman Neuro because it carries incorrect instructions on mixing ratios, which can result in the liquid mixture solidifying too slowly in unintended areas, potentially leading to embolization or reflux into arteries and pulmonary vessels.
Tasimelteon (Hetlioz) to treat non-24-hour sleep-wake disorder in totally blind individuals. The melatonin receptor agonist is the first FDA-approved treatment for the disorder. Approval was based on 2 trials with 104 participants in which the drug increased nighttime sleep and decreased daytime sleep compared to placebo. The most common side effects were headache, elevated liver enzymes, nightmares or unusual dreams, disturbed night's sleep, upper respiratory or urinary tract infection and drowsiness.
A new indication for the Dexcom G4 Platinum Continuous Monitoring System for patients ages 2 to 17 years with diabetes. The system, which monitors blood glucose levels, had already been approved for patients ages 18 and older.
A new combined use of trametinib (Mekinist) and dabrafenib (Tafinlar) to treat advanced unresectable or metastatic melanoma. In May 2013, the FDA approved the drugs as single agents for the same indication. Approval of the combination was based on a trial of 162 participants in which more patients had longer-lasting objective response than on single-drug treatment. The most common side effects included fever, chills, tiredness, rash, nausea, vomiting, diarrhea, abdominal pain, peripheral edema, cough, headache, joint pain, night sweats, decreased appetite, constipation and muscle pain.
The Affymetrix CytoScan Dx Assay to detect chromosomal variations that may be responsible for a child's developmental delay or intellectual disability. Based on a blood sample, the test can analyze the entire genome and detect large and small chromosomal changes. In a comparison of 960 blood specimens, the new assay performed better karyotyping and FISH chromosomal tests. This device should not be used for stand-alone diagnostic purposes, preimplantation or prenatal testing or screening, population screening, or the detection of or screening for acquired or genetic aberrations occurring after birth.
The risk of stroke, heart attack, and death in men taking testosterone products is being investigated by the FDA, according to a recent announcement. The investigation is motivated by publication of 2 studies suggesting an increased risk of cardiovascular events with the drugs. The agency will communicate its final conclusions and recommendations, and in the meantime, clinicians should follow the drugs' prescribing information and consider whether the benefits of testosterone treatment are likely to exceed the potential risks.
A possible increase in heart failure associated with saxagliptin (Onglyza and Kombiglyze XR) is also being investigated by the FDA. The agency recently requested data from a manufacturer-sponsored trial that found an increased rate of hospitalization for heart failure compared to a placebo group. The manufacturer is expected to submit the data to the FDA by early March 2014, after which the agency will conduct a thorough analysis and report the findings. The analysis is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk, and clinicians should continue to follow the prescribing recommendations in the drug labels, the agency advised.