Details on the latest warnings, recalls, and approvals.
A drug safety communication that canagliflozin (Invokana, Invokamet) causes an increased risk of leg and foot amputations. The conclusion is based on new data from two large clinical trials of the type 2 diabetes medication in which leg and foot amputations occurred about twice as often in patients treated with the drug compared to patients treated with placebo. Amputations of the toe and middle of the foot were most common, although leg amputations below and above the knee also occurred. The FDA is requiring the addition of new warnings about this risk, including a boxed warning, to canagliflozin drug labels.
A drug safety communication clarifying the risks of oral and injectable fluoroquinolones. Patient cases and research findings do not currently support reports that the antibiotics may result in detachment of the retina in the eyes, aortic aneurysm, or aortic dissection. The FDA will continue to assess safety issues with the drug class.
A drug safety communication about gadolinium-based contrast agents for MRI. An FDA review, initiated in July 2015, has identified no harmful health effects from gadolinium retained in the brain after use of these agents for MRI but will continue to assess safety through additional research.
A class I recall of the HeartMate II LVAS pocket system controller due to risk of patient injury and/or death during backup controller exchange. The manufacturer has received 70 reports of incidents, including 19 injuries and 26 deaths, in which the controller malfunctioned after an exchange. All deaths occurred when patients tried to exchange controllers while away from the hospital. The recall includes 28,882 devices manufactured between July 2012 and December 2016 and distributed between July 2012 and March 2017.
A previous voluntary field action on HVAD system controllers and DC adapters reclassified as a class I recall. The previous field safety notices occurred in April 2015 and April 2016 and described potential safety issues due to worn alignment guides, battery failure, and loose power and data connecters. In April 2017, the FDA approved an updated controller, which was introduced to address these issues, so Medtronic, the manufacturer, has begun to remove current HVAD controllers from hospitals.
A class I recall of certain lots of three coronary catheters: the NC Trek RX coronary dilatation catheter, NC Traveler coronary dilatation catheter, and NC Tenku RX PTCA balloon catheter. The 132,040 recalled devices were manufactured between 2015 and 2017 and distributed between Jan. 1, 2015, and March 14, 2017. Affected catheters may have a difficult-to-remove protective balloon sheath, which could cause issues with inflation or deflation that may lead to air embolism, additional intervention, thrombosis, and myocardial infarction. In one case, failure to deflate the balloon required surgery, which resulted in multiple postoperative complications that led to the patient's death.
A class I recall of the V60 noninvasive ventilator due to faulty cable pins that may cause the device to shut down unexpectedly. A total of 20,690 recalled devices were manufactured between April 2, 2009, and Sept. 15, 2015, and distributed between April 4, 2009, and Sept. 14, 2015.
A warning about the risk of inaccurate results from certain lead tests that process venous blood samples. The LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra testing systems are affected by this warning. The tests may provide inaccurate results for some children and adults, potentially leading to improper management and treatment of patients for lead exposure or poisoning. Discontinue use of these testing systems with venous blood samples, although they may still be used with capillary blood samples. The FDA and CDC are working with the manufacturer to investigate the root cause of the issue.
Pembrolizumab (Keytruda) to treat patients whose cancers have a specific biomarker. This is the first approval of a cancer treatment based on a common biomarker rather than where the tumor originated in the body. The drug targets the PD-1/PD-L1 pathway and is approved for patients with unresectable or metastatic solid tumors with a biomarker referred to as microsatellite instability-high or mismatch repair-deficient. The indication includes patients with solid tumors that have progressed despite prior treatment and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs. The drug was studied in five uncontrolled, single-arm clinical trials including 149 patients who received the drug. In the trials, the most common cancers were colorectal, endometrial, and other gastrointestinal cancers. A total of 39.6% of the participants had a complete or partial response to the drug, and 78% of them had a response that lasted six months or more. Common side effects include fatigue, pruritus, diarrhea, decreased appetite, rash, pyrexia, cough, dyspnea, musculoskeletal pain, constipation, and nausea. Serious risks include immune-mediated side effects, such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.