Recalls for oral docusate sodium, INR monitoring system

Recalls

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 of which identify 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 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.

Approvals

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 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 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.

Adapalene (Differin Gel 0.1%) for the over-the-counter treatment of acne in patients ages 12 and older. The once-daily topical retinoid gel contains the first new active ingredient for over-the-counter acne treatment since the 1980s. In consumer studies, patients were able to understand the over-the-counter label, select the correct product, and use the product appropriately. Additionally, a maximal use trial showed that skin absorption is limited.

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, patients 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.

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.

Miscellaneous

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.