Warning on infections associated with heater-cooler devices

Details on the latest recalls, warnings, and approvals.


Recalls, warnings, and safety alerts

A safety review determined that long-term use of clopidogrel (Plavix) does not increase or decrease overall risk of death in patients with or at risk for heart disease. Compared to short-term (6 months or less) dual antiplatelet therapy with clopidogrel and aspirin or aspirin alone, long-term (12 months or longer) clopidogrel and aspirin did not appear to change the overall risk of death or cancer-related adverse events.

Photo by Thinkstock
Photo by Thinkstock

A safety alert on sodium polystyrene sulfonate (Kayexalate) and the possibility of drug interactions. The drug's approved labeling contains a warning not to take other oral medications within 6 hours of administration and describes the drug's potential to decrease absorption of lithium and thyroxine, but extensive drug interactive studies have not been performed, and the FDA recently identified interactions with another potassium-lowering drug. The manufacturer is studying the issue, and if these studies confirm interactions with other medications, the FDA will require drug label updates.

A safety review found no clear evidence of a link between entacapone for the treatment of Parkinson's disease and increased risk of heart attacks, stroke, or other cardiovascular events. Therefore, recommendations for using entacapone (Comtan) and combination entacapone, carbidopa, and levodopa (Stalevo) will remain the same. Carbidopa and levodopa have not been shown to have an increased cardiovascular risk.

A warning about nontuberculous mycobacteria (NTM) infections associated with heater-cooler devices, which are used to warm or cool patients during cardiothoracic surgeries and other procedures. The FDA received 32 associated medical device reports between January 2010 and August 2015, including 25 in 2015 alone. Several patients have died from these infections. Although water in the device does not come into direct contact with patients, contaminated water could transmit bacteria through the air into the environment. NTM organisms are found in soil and water, including tap water sources, and may cause infections in very ill or immunocompromised patients. Facilities should strictly adhere to the manufacturer's instructions.

A mandatory recall of all automated endoscope reprocessors (AERs) manufactured by Custom Ultrasonics because of continued violations that could result in an increased risk of infection transmission. Violations include the inability to validate that the AERs can adequately wash and disinfect endoscopes.

A warning that combination dasabuvir, ombitasvir, paritaprevir, and ritonavir (Viekira Pak) and combination ombitasvir, paritaprevir, and ritonavir used with ribavirin (Technivie) can cause serious liver injury, most commonly in patients with underlying advanced liver disease. After identifying cases of hepatic decompensation and liver failure in patients with underlying cirrhosis who were taking these combinations, the FDA required the manufacturer to add information about serious liver injury adverse events to the drug labels. In most cases, liver injury occurred within 1 to 4 weeks of starting treatment, sometimes resulting in liver transplantation or death.

A recall of all 0.15-mg and 0.3-mg epinephrine injections (Auvi-Q) with expiration dates from March to December 2016, due to potentially inaccurate dosage delivery. The manufacturer had received at least 26 reports of suspected device malfunctions but no associated patient deaths.

A recall of certain lots of Myocardial Protection System delivery sets due to possible seal failure along the blood source channel of main pump cassette. The manufacturer has received 20 complaints of this seal failure, which have resulted in 16 instances of patient blood loss during surgery, although no patient injuries have been reported. Recalled products were distributed from June to September 2015.

Approvals

Patiromer for oral suspension (Veltassa) to treat hyperkalemia. Taken with water, the powdered medication works by binding potassium in the gastrointestinal tract, decreasing its absorption. The drug effectively lowered potassium levels in hyperkalemic participants with chronic kidney disease who were taking at least 1 drug that inhibited the renin-angiotensin-aldosterone system. The most common adverse reactions were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence. It carries a boxed warning that it may decrease the absorption and effects of other oral drugs.

Combination elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (Genvoya) to treat HIV infection in patients 12 and older. In 4 clinical trials of 3,171 participants, it was compared to existing approved HIV treatments and found to be comparably effective. Patients receiving the drug regimen experienced greater increases in total and low-density lipoprotein cholesterol. The most common side effect is nausea, and serious side effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution, and immune reconstitution syndrome.