Recalls and warnings
A recall of Diocto Liquid, an oral liquid docusate sodium solution, because of contamination with Burkholderia cepacia, which has been linked to an outbreak in 5 states. The FDA has received several reports of adverse events of B. cepacia infections, some associated with other liquid docusate sodium products, and it continues to investigate. Clinicians should not use any liquid docusate sodium product as a stool softener or for any other medical purpose, according to the FDA and the CDC.
A class I recall of HeartWare Ventricular Assist Device batteries because they may lose power prematurely due to faulty cells. If the system is not connected to an alternate power source shortly after the low-battery alarm sounds, the pump will stop working, potentially causing death or other serious health consequences. The recall involves 18,631 units nationwide.
A recall of the Alere INRatio and INRatio2 PT/INR Monitoring System because it may provide a significantly lower international normalized ratio result than a laboratory method. The manufacturer developed and submitted software enhancements to the FDA at the end of 2015, but the agency believed the company's studies did not adequately demonstrate efficacy of the software modification and advised the voluntary recall.
A warning about the risk of serious bleeding when using over-the-counter aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Although these products already contain warnings of this bleeding risk on their labels, the FDA continues to receive reports of bleeding and will continue to evaluate this safety issue.
A recall of 1 lot of 50% magnesium sulfate injection, 10 g/20 mL (0.5 g/mL), because of the presence of particulate matter within 1 single-dose vial. A previous recall for this lot came in response to a confirmed high out-of-specification result for pH. No related adverse events have been reported.
A class I recall of specific lots of Guardian II hemostasis valves used in catheterization procedures because they pose an increased risk of air leakage that may lead to an embolism. This recall does not include the Guardian II NC hemostasis valves. No related injuries have been reported.
A statewide recall in Nevada of all unexpired sterile products compounded by Well Care Compounding Pharmacy due to lack of sterility assurance. The recall, which was initiated after an FDA inspection, applies to all sterile compounded products distributed between Jan. 1 and April 29, 2016.
A warning not to use drugs intended to be sterile that were produced by Medaus Inc. due to lack of sterility assurance. The FDA requested that the compounding pharmacy recall all nonexpired lots of drug products intended to be sterile, but the company has refused to do so.
A recall of a single lot of bupivacaine HCl (Sensorcaine-MPF) injection, 0.75%, 7.5 mg/mL, 30-mL fill in a 30-mL vial, due to particulate matter identified as glass. The manufacturer observed the particulate matter during inspection of reserve samples. This recall carries over to sterile preparations compounded with the recalled lot of bupivacaine HCl.
A class I recall of all models of the Fetch 2 Aspiration Catheter in response to complaints of shaft breakage. There have been no reports of patient injury or death, and there is no risk to patients who have already undergone procedures with the catheter.
A class I recall of the GlideScope Titanium single-use video laryngoscope because of a potential disruption in the video feed from the camera in the laryngoscope blades to the monitor. A disrupted or unstable video could lead to delayed tracheal tube insertion, intubation failure, hypoxemia, end-organ damage, or death.
A warning on neurosurgical skull clamps about possible slippage before and/or during surgical procedures. From January 2009 to January 2016, the FDA received more than 1,000 medical device reports of this nature, and these incidents resulted in more than 700 injuries, such as skull fractures, facial bruises and cuts, lacerations, and hematomas. In addition, unintended patient movement has caused inaccurate stereotaxic navigation and delayed, prolonged, or halted procedures. Data suggest that slippage is not specific to any manufacturer or brand of devices and that the causes of slippage are multifactorial and may include mechanical failure of the device, issues with device placement, and patient-specific characteristics. The FDA stated that the overall benefits of these devices outweigh the risks, although clinicians should be aware of patient-specific characteristics, as well as proper maintenance and use of these devices.
A warning not to use drug products intended to be sterile that were produced and distributed by I.V. Specialty because of lack of sterility assurance. After investigators observed insanitary conditions during a recent inspection, the FDA recommended that the company cease sterile product production until corrective actions are implemented, as well as recall all nonexpired drug products intended to be sterile. The company has neither ceased production nor initiated a recall.
The Xpert Carba-R Assay to detect specific genetic markers associated with carbapenem-resistant Enterobacteriaceae in specimens. The assay tests specimens taken directly from patients, usually by rectal swabs, for the presence of 5 genetic markers associated with carbapenemase. Intended as an infection control aid, the assay can be used in conjunction with other clinical and laboratory findings.
The first fully absorbable stent to treat coronary artery disease. Manufactured from a biodegradable polymer, the Absorb GT1 Bioresorbable Vascular Scaffold System is gradually absorbed by the body in about 3 years and releases everolimus to limit the growth of scar tissue. A randomized trial of 2,008 patients compared the device to a drug-eluting metallic stent and found that after 1 year, the major cardiac adverse event rate of 7.8% was clinically comparable to the 6.1% rate in the control group. The rate of blood clots forming within the devices after 1 year was 1.54% for the absorbable stent and 0.74% for the control. Potential adverse events include allergic reactions, internal bleeding, embolism, and other coronary artery complications.
The first focused ultrasound device to treat essential tremor in patients who have not responded to medication. Using magnetic resonance images, ExAblate Neuro delivers focused ultrasound to destroy brain tissue in a small area believed to be responsible for causing tremors. Patients are awake and responsive during the treatment. In a trial of 76 patients, those treated with the device showed almost 50% improvement in their tremors and motor function after 3 months and retained a 40% improvement in composite tremor and motor function scores after 1 year. Potential side effects include tissue damage and hemorrhage, and adverse events are consistent with those reported for thalamotomy surgery, such as headache and ataxia.
Obeticholic acid (Ocaliva) to treat primary biliary cholangitis as a single therapy or in combination with ursodeoxycholic acid. The drug is given orally and binds to the farnesoid X receptor. A clinical trial showed that after 12 months, the proportion achieving reductions in alkaline phosphatase levels was higher among treated participants than participants receiving placebo. The most common side effects are pruritus, fatigue, abdominal pain and discomfort, arthralgia, oropharyngeal pain, dizziness, and constipation.
An injectable, radioactive diagnostic agent (Axumin) for positron emission tomography imaging in men with suspected prostate cancer recurrence. Comparisons with biopsy results and C11 choline scans supported the safety and efficacy of the diagnostic agent for imaging prostate cancer in men with elevated prostate-specific antigen levels following prior treatment. The most commonly reported adverse reactions are injection site pain, redness, and metallic taste.
The first vaccine to prevent cholera (Vaxchora) caused by serogroup O1 in adults 18 through 64 years old who are traveling to cholera-affected areas. The live, weakened vaccine is taken as a single oral dose of about 3 fluid ounces at least 10 days before travel. In a vaccine-challenge study, the vaccine was 90% effective among those challenged 10 days after vaccination and 80% effective among those challenged 3 months after vaccination. The most common adverse reactions were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, and diarrhea.
The cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug erlotinib (Tarceva), to detect epidermal growth factor receptor gene mutations in patients with non-small-cell lung cancer. Detecting these mutations in patients' blood samples aids in selecting those who might benefit from treatment with erlotinib, but a tumor biopsy should be performed if such mutations are not detected in the blood.
The Raindrop Near Vision Inlay, a device implanted in the cornea of 1 eye to improve near vision in certain patients with presbyopia. The device is made of a hydrogel material and resembles a contact lens smaller than the eye of a needle. After an eye surgeon implants the device, the inlay works by reshaping the curvature of the cornea and correcting the refractive error. It is indicated for use in patients ages 41 to 65 who have not had cataract surgery; are unable to focus clearly on near objects or small print; need reading glasses with +1.50 to +2.50 diopters of power; and do not require glasses or contacts for clear distance vision. In a clinical trial, 336 out of 364 patients (92%) were able to see with 20/40 vision or better at near distances 2 years after implantation. The device may cause side effects such as infection, complications of the cornea, epithelial ingrowth, and inflammation.
The first intraocular lens for cataract surgery that improves visual acuity at near, intermediate, and far distances. The Tecnis Symfony intraocular lens may reduce the need for patients to wear contact lenses or glasses after cataract surgery. A trial compared 148 patients who received the lens to 151 patients who received a monofocal intraocular lens and found that 77% of patients with the new lens had good vision (20/25) without glasses at intermediate distances, compared to 34% of those with the monofocal lens. At near distances, patients with the new lens were able to read 2 additional, progressively smaller lines on a standard eye chart than those with the monofocal lens. Both groups had comparable results for good distance vision. Potential side effects include worsening of or blurred vision, bleeding, and infection.
Adapalene (Differin Gel 0.1%) for the over-the-counter (OTC) treatment of acne in patients ages 12 and older. The once-daily topical retinoid gel contains the first new active ingredient for OTC acne treatment since the 1980s. In consumer studies, patients were able to understand the OTC label, select the correct product, and use the product appropriately. Additionally, a maximal use trial showed that skin absorption is limited.
A proposed rule requesting additional data on certain active ingredients used in over-the-counter topical consumer antiseptic rubs, including hand sanitizers. The request is to ensure that regular use of these products does not present unknown safety and efficacy concerns. If finalized, the rule would require manufacturers to provide the FDA with additional safety and effectiveness data on 3 ingredients: alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride.
An investigation of adverse event reports linked to WEN by Chaz Dean Cleansing Conditioners. Reports include hair loss, hair breakage, balding, itching, and rash, and no possible cause for these events has been determined. Consumers who experience a reaction associated with the product should discontinue use and consult their dermatologist or other clinician.