Recalls and warnings
A Class I recall of Avea ventilators by CareFusion in response to a potential malfunction of the 5 psi pressure transducer. Affected ventilators may develop a failure mode over a period of time and activate false extended high peak or circuit occlusion alarms before opening the safety valve and discontinuing ventilation.
A recall of Vascu-Guard peripheral vascular patch by Baxter because of customer difficulty distinguishing its smooth from rough surfaces. This is caused by a deviation in the surface texture of the vascular patch in a new packing configuration. Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and embolism.
An expanded recall, including several lots of gemcitabine for injection and 1 lot of methotrexate injection, of hospital-level products by Mylan due to the presence of visible foreign particulate matter observed during testing of retention samples.
A Class I recall of HeartWare Ventricular Assist System because the alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, eventually preventing the patient from connecting the device controller. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death .
A warning on ceftolozane and tazobactam (Zerbaxa) about the risk for dosing errors because of confusion about the drug strength displayed on the vial and carton labeling. The drug's vial label was initially approved with a strength that reflects each active ingredient (e.g., 1 g/0.5 g), but the product is dosed based on the sum of the ingredients (e.g., 1.5 g). Medication errors have been reported that in some cases led to administration of 50% more of the drug than prescribed, but no adverse events were reported. The drug labeling has been revised to reflect the sum of the 2 active ingredients.
A warning on unintentional injection of soft tissue filler into blood vessels in the face, which poses the risk of serious patient injury. The FDA is working with manufacturers to update their labeling to include additional warnings and precautions about the risks, which include embolization that leads to vision impairment, blindness, stroke, and necrosis.
A warning that the methylphenidate transdermal system (Daytrana) can cause permanent loss of skin color. The drug label now warns of chemical leukoderma, which has been reported in areas up to 8 inches in diameter. Clinicians should discontinue use of the patch and consider alternative treatments for patients who experience this condition.
A recall of Covidien Shiley neonatal and pediatric tracheostomy tubes. Affected products were formed with a wider-angle bend than standard models manufactured after Nov. 29, 2012, resulting in customer complaints that included reports of 12 serious patient injuries, such as discomfort or breathing difficulties that impacted oxygen levels immediately upon tube placement.
An alert that a counterfeit version of onabotulinumtoxinA (Botox) may have been sold to doctors' offices and medical clinics nationwide. The product was sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the United States, and it should not be used. The counterfeit product may be identified by the vial missing the lot number; the outer carton not having any entries next to the LOT, MFG, and EXP listings; and the outer carton and vial displaying the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.”
A safety communication about quality problems with mammograms performed at Coastal Diagnostic Center in Pismo Beach, Calif., on or after Feb. 24, 2013, and those at Richard D. Adelman, MD, Family Medicine in Raleigh, N.C., after Aug. 24, 2012. Patients who had mammograms at these facilities should consider having their mammograms re-evaluated at a certified facility to determine if they need a repeat mammogram or additional medical follow-up.
The Senza spinal cord stimulation system to manage chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain, and leg pain. The system can reduce pain without producing paresthesia by providing high-frequency stimulation and low-stimulation amplitudes. Before implantation, patients participate in a 1- to 2-week simulation with a model worn outside the body. In a trial, 75% of treated patients achieved a 50% reduction in pain from baseline at 3 months and a 55% reduction at 12 months. There were no stimulation-related neurological deficits. The most common adverse events were pain at the implant site and dislocation of the device lead under the skin.
The SAPIEN 3 Transcatheter Heart Valve (THV) for patients with aortic valve stenosis who are inoperable or at high risk for death or complications associated with open-heart surgery. The third-generation design of the THV includes a skirt at the base of the valve to minimize leakage through and around the valve. Approval was based on a study showing that the rate of moderate or greater aortic insufficiency at 30 days was 3% in patients receiving the new valve compared to 14.3% in those with the original model. Risks of implantation include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. The device is contraindicated for patients who cannot tolerate anticoagulation/antiplatelet therapy.
The Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce Parkinson's disease and essential tremor symptoms. The system consists of a small battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and wire leads that attach to electrodes placed within the brain. Patients in 2 separate clinical studies showed statistically significant improvement in symptoms with the device on as opposed to off. Serious adverse events included intracranial bleeding, which can lead to stroke, paralysis, or death, as well as infection and dislocation of the device lead under the skin.
Sirolimus (Rapamune) to treat lymphangioleiomyomatosis (LAM). This orphan drug is the first drug approved to treat the disease. In a clinical trial, patients taking the drug experienced stabilization of lung function compared with a placebo group (an average difference in forced expiratory volume in 1 second of 153 mL). The most common side effects were mouth and lip ulcers, diarrhea, abdominal pain, nausea, sore throat, acne, chest pain, leg swelling, upper respiratory tract infection, headache, dizziness, muscle pain, and elevated cholesterol. The drug, which is available as both a tablet and an oral solution, was originally approved in 1999 as an immunosuppressive agent to help prevent organ rejection in patients receiving kidney transplants.
Eluxadoline (Viberzi) to treat irritable bowel syndrome with diarrhea (IBS-D) in adults. Taken orally, twice a day with food, it activates receptors in the nervous system that can lessen bowel contractions. Trials showed that it simultaneously reduced abdominal pain and improved stool consistency compared to placebo. The most common side effects include constipation, nausea, and abdominal pain, and the most serious known risk is spasm in the sphincter of Oddi, which can result in pancreatitis. It should not be used in patients with a history of bile duct obstruction, pancreatitis, severe liver impairment, or severe constipation, or in patients who drink more than 3 alcoholic beverages per day.
Rifaximin (Xifaxan), for IBS-D in adults. It can be taken orally 3 times a day for 14 days to treat abdominal pain and diarrhea. Patients who experience a recurrence of symptoms can be retreated with a 14-day course up to 2 times. The exact mechanism of action is unknown but is thought to be related to changes in the gastrointestinal tract's bacterial content. Trials showed that more patients reported reduced abdominal pain and improved stool consistency on the drug compared to placebo. An additional trial of repeat courses showed more patients responding to it than placebo. The most common side effects include nausea and an increase in alanine aminotransferase. If diarrhea does not improve or worsens after treatment, then evaluation for C. difficile enterocolitis should be performed. Caution should be used when the drug is prescribed in patients with severe liver impairment or combined with P-glycoprotein inhibitors.
Deoxycholic acid (Kybella), to treat moderate-to-severe fat below the chin, known as submental fat. It is administered as an injection into the fat tissue in the submental area, with up to 50 injections in a single treatment and up to 6 single treatments administered no less than 1 month apart. Safety and effectiveness are based on 2 clinical trials with 1,022 patients, showing that reductions in submental fat were observed more frequently on the drug than placebo. Serious side effects include nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects include swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.
The KAMRA inlay, a corneal implant to improve near vision in certain patients with presbyopia. It is intended for use in patients 45 to 60 years old who have not had cataract surgery, are unable to focus clearly on near objects or small print, and need reading glasses with +1.00 to +2.50 diopters of power but do not need glasses or contacts for clear distance vision. Safety and efficacy are based on 3 clinical studies, showing that 83.5% of the evaluable 478 participants had 20/40 or better vision at 12 months. The device is not intended for patients with past cataract surgery, severe dry eye, active eye infection or inflammation, certain corneal abnormalities, recent or recurring herpes eye infection, uncontrolled glaucoma, uncontrolled diabetes, or active autoimmune or connective tissue disease. The inlay may cause or worsen dry eye and various vision-related problems and can cause corneal complications, sometimes permanent. There is also risk for the focusing power of the eye to change, causing blurry vision and requiring glasses.
A new indication for moxifloxacin (Avelox) to treat plague, including pneumonic plague and septicemic plague. It is also approved for prevention of plague in adult patients. Approval was based on an animal efficacy study conducted in African green monkeys infected with Yersinia pestis in a laboratory setting. All 10 monkeys treated with the drug survived compared to none of the 10 monkeys on placebo. Common side effects are nausea, diarrhea, headache, and dizziness. The drug carries a boxed warning about increased risk of tendinitis and tendon rupture and worsening of muscle weakness in people with myasthenia gravis. Other side effects include allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm.
The Impella 2.5 System, a miniature blood pump system for temporary use by patients with severe symptomatic coronary artery disease and diminished (but stable) heart function who are undergoing high-risk percutaneous coronary intervention but are not candidates for surgical coronary bypass treatment. Approval was based on evidence that using the system during high-risk percutaneous coronary intervention could allow a longer and more thorough procedure by preventing episodes of hemodynamic instability and reduce later adverse events compared to an intra-aortic balloon pump.
Dinutuximab (Unituxin) to treat pediatric patients with high-risk neuroblastoma. It was approved under the orphan product program and carries a boxed warning about the risk of irritated and severely painful nerve cells, nerve damage, and life-threatening infusion reactions.
Cholic acid (Cholbam) capsules to treat bile acid synthesis disorders due to single enzyme defects and peroxisomal disorders (including Zellweger spectrum disorders). Efficacy for both indications was assessed in small trials lasting 18 years, which showed improvements in liver function tests and weight. The most common side effect was diarrhea. Use of the drug should be carefully monitored by an experienced hepatologist or pediatric gastroenterologist.