Warning about posaconazole formulation confusion


Recalls and warnings

A warning that differences in dosing regimens between the 2 oral formulations of posaconazole (Noxafil) have resulted in dosing errors. Since the November 2013 approval of the delayed-release tablets, the FDA has received 11 reports of the wrong formulations being prescribed and dispensed to patients. One case resulted in death, and another case resulted in hospitalization. Reports indicate that these were a result of clinicians not knowing that the oral suspension and a delayed-release tablet cannot be substituted for each other without adjusting the dose. The drug labels have been revised to indicate this information, and prescribers should specify dosage form, strength, and frequency on all prescriptions for posaconazole.

Photo by Thinkstock
Photo by Thinkstock

A class I recall of the Etest PIP/TAZO/CON-4 PTC 256 because test results may erroneously indicate that piperacillin/tazobactam could stop or slow the growth of certain bacteria. The error may result in inappropriate infection treatment and could cause increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and death. Clinicians should discontinue using all affected products.

A recall of 2 lots of intravenous solutions because of the potential presence of particulate matter. The affected lots were of 0.9% sodium chloride injection in a 250-mL Viaflex container and 70% dextrose injection (2,000 mL). In each case, the particulate matter was determined to be an insect prior to patient administration, and no related adverse events have been reported.

A recall of 1 lot of magnesium sulfate in water for injection because of an incorrect barcode. The product's primary container may be mislabeled with an incorrect barcode, although the printed name is correct. No related adverse events have been reported.

A recall of certain lots of 4 mg and 8 mg (16 mcg/mL and 32 mcg/mL) norepinephrine bitartrate added to 0.9% sodium chloride in 250-mL Viaflex bags because of reports from hospitals noting a slight discoloration in the admixture. The manufacturer's prescribing information advises not to use the product if it is discolored. No adverse events have been reported.

A class I recall of the optional PS500 battery supply in Evita V500 ventilators because a software issue may cause the devices to shut down unexpectedly. In addition to causing shorter than expected battery run times, the issue also prevents the appropriate alarm from sounding 5 minutes before the battery runs out of power and the device shuts down.

A class I recall of the Perseus A500 anesthesia workstation because a faulty power switch may cause the device to alarm and shut down unexpectedly. The manufacturer has received 1 report of this issue, with no injuries or deaths. The manufacturer is replacing power switches of affected workstations free of charge, but until then, users should operate them under continuous supervision.

A class I recall of 34 Fuhrman pleural and pneumopericardial drainage sets because the included catheter may break during insertion. The manufacturer received 2 such reports, and both cases resulted in medical intervention.

Approvals

Selexipag (Uptravi) tablets to treat pulmonary arterial hypertension (PAH). The oral prostacyclin receptor agonist decreases pressure in the lungs' blood vessels by relaxing muscles in the vessel walls and dilating the vessels. About 1,200 clinical trial participants were randomized to selexipag or placebo for a median treatment time of 1.4 years. Those taking the orphan drug were less likely to experience disease progression and less likely to be hospitalized for PAH than those taking placebo. Common side effects include headache, diarrhea, jaw pain, nausea, myalgia, vomiting, extremity pain, and flushing.

Lesinurad (Zurampic) in combination with a xanthine oxidase inhibitor to treat hyperuricemia associated with gout. The drug helps the kidneys excrete uric acid by inhibiting the function of transporter proteins involved in uric acid reabsorption. In 3 placebo-controlled studies involving about 1,500 participants, those taking the drug with a xanthine oxidase inhibitor showed reduced serum uric acid levels compared to those taking placebo. The most common side effects include headache, influenza, increased blood creatinine level, and gastroesophageal reflux disease. The drug has a boxed warning on the risk for acute renal failure, which is more common when it is used without a xanthine oxidase inhibitor and in higher-than-approved doses. The FDA is also requiring a postmarketing study to further evaluate the drug's renal and cardiovascular safety.

Insulin glargine injection (Basaglar), a long-acting human insulin analog, for improving glycemic control in adults with type 1 or type 2 diabetes. The drug is administered subcutaneously once daily at the same time every day. Its similarities to an already-approved insulin glargine injection (Lantus) allowed it to be the first insulin product approved through an abbreviated approval pathway. In 2 clinical trials of the drug, the most common adverse reactions were hypoglycemia, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, edema, and weight gain. As with any insulin, severe allergic or skin reactions may occur. This drug should not be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine or 1 of its ingredients.