Recalls and warnings
Revisions to the warning labels on statins. The recommendation for routine monitoring of liver enzymes was replaced with a recommendation that the tests be performed before starting statins and as clinically indicated thereafter. Warnings were added about potential for generally non-serious and reversible cognitive side effects (rare cases of which have been reported) and increased blood sugar and glycosylated hemoglobin levels. The label for lovastatin has received additional updates, including new contraindications and dose limitations when the drug is taken with certain medications that can increase the risk for myopathy/rhabdomyolysis.
A labeling change to protease inhibitors about interaction risks with statins. Co-administration of HIV or hepatitis C protease inhibitors with certain statins can increase the risk of myopathy/rhabdomyolysis. Clinicians should follow the recommendations on the drug labels when prescribing these drugs.
A recall of certain automatic external defibrillators (AEDs), which contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy. Affected AEDs include Cardiac Science Powerheart, CardioVive, and CardioLife; GE Responder and Responder Pro; and Nihon Kohden.
A recall of the alarm cable for the Newport HT50 Ventilator because it may cause an electrical shortage that can cause the ventilator to shut down unexpectedly.
A recall of one lot (F73652) of Prevnar 13 pneumococcal 13-valent conjugate vaccine 0.5-mL pre-filled syringes because the lot was formulated and filled with expired serotype 3 conjugate material.
A recall of additional lots of norgestimate and ethinyl estradiol tablets due to the possibility of out-of-sequence tablets, this time from Glenmark Generics Inc. Affected doses include 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg.
A recall of certain lots of Smiths Medical Bivona neonatal, pediatric and FlexTend tracheostomy tubes because difficulty disconnecting accessories from the connectors of the affected tubes may result in use of excessive force, and the tracheostomy tube may dislodge from patients. This could lead to serious patient injury or death, especially if no replacement tube is immediately available.
A recall of three lots of Bedford Laboratories' cytarabine for injection after an inspection revealed potentially elevated risk of lack of sterility in the manufacturing process.
A recall of infant Tylenol oral suspension, 1 oz grape, after consumers reported difficulty using the medication's dosing system. No adverse events have been reported to date.
A recall of CareFusion's Nicolet cortical stimulator control unit because the device's software incorrectly indicates stimulation is delivered to a different electrode than the one selected and a short circuit may develop between the cortical stimulator control unit and the stimulus switching unit amplifier. These issues may result in the surgeon resecting the wrong brain tissue.
A recall of one lot (0693) of American Regent's phenylephrine HCl injection, USP, 1% (10 mg/mL), 5 mL, due to visible particles.
Mifepristone (Korlym) to control hyperglycemia in adults with endogenous Cushing's syndrome. The drug was approved for use in patients with this syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery, but it is contraindicated in pregnant women. The safety and efficacy of this orphan drug were evaluated in a clinical trial with 50 patients.
An expanded approval for BreathTek UBT to detect Helicobacter pylori bacterial infections in children age 3 to 17 years. Approval was based on a multi-center study of 176 patients, comparing the test's performance to a composite reference method and demonstrating 95.8% sensitivity and 99.2% specificity. The test was approved for adults in 1996.