First AI device approved to detect diabetic retinopathy

This column reviews details on recent recalls, warnings, and approvals.


Recalls, warnings, and alerts

A warning that lamotrigine (Lamictal) can cause a serious immune system reaction. The reaction, called hemophagocytic lymphohistiocytosis (HLH), typically presents as a persistent fever and can lead to severe problems with blood cells and organs such as the liver, kidneys, and lungs. Prompt recognition and early treatment of HLH is crucial to improve outcomes and decrease mortality.

A recall of injectable products by Premier Pharmacy Labs due to a potential lack of sterility assurance. Microbial contamination was detected during routine testing of unreleased products due to interaction between the syringe and container closure. Recalled products, which include morphine, hydromorphone, and neostigmine methylsulfate, were distributed in March 2018.

A class I recall of BD Vacutainer EDTA Blood Collection Tubes due to chemical interference with certain tests. The recall includes tubes with lavender, tan, pink, and green rubber stoppers, which contain a chemical that interferes with the accuracy of the anodic stripping voltammetry testing methodology.

An alert that certain connectors used in gastrointestinal endoscopy pose a risk of cross-contamination and are not recommended. Endoscope connectors that are labeled for use in multiple patients within a 24-hour period without reprocessing are not recommended for use because the FDA has not received acceptable data demonstrating their safety. Endoscope connectors that are designed according to FDA recommendations are widely available.

A recall of all nonexpired products marketed as sterile and produced by Coastal Meds due to a lack of sterility assurance. During an FDA inspection, the agency observed visible particles in some injection drug vials and poor sterile production practices.

An alert about magnetic resonance thermometry reliability with magnetic resonance-guided laser interstitial thermal therapy devices. The FDA is evaluating preliminary data suggesting that potentially inaccurate magnetic resonance thermometry information may be displayed during treatment.

Miscellaneous

A firmware update to certain implantable cardiac devices by Abbott to improve battery performance and reduce the risk of exploitation of cybersecurity vulnerabilities. The update should be completed for affected patients at their next regularly scheduled visit or when appropriate, depending on patient and physician preferences.

An order to restrict the sale and distribution of the Essure permanent contraception device. Some women were not adequately informed of the device's risks before implantation. Therefore, the FDA is requiring a unique type of restriction, permitting sale and distribution only to clinicians and facilities that provide information to patients about the device's risks and benefits.

Complaints filed in federal court seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval. The two clinics, which were previously warned, are US Stem Cell Clinic LLC of Sunrise, Fla., and California Stem Cell Treatment Center Inc., which has locations in Rancho Mirage, Calif., and Beverly Hills, Calif. The FDA maintains that some patients have suffered serious and permanent harm after receiving unapproved products and also alleges significant deviations from current requirements for appropriate manufacturing practice.

Approvals

Marketing of the first medical device to use artificial intelligence to detect diabetes-related eye problems. The software program, called IDx-DR, analyzes images of the eye taken with a retinal camera called the Topcon NW400, providing the physician with one of two results: 1) “more than mild diabetic retinopathy detected: refer to an eye care professional” or 2) “negative for more than mild diabetic retinopathy; rescreen in 12 months.” In a study of 900 patients at 10 primary care sites, the device correctly identified the presence of more than mild diabetic retinopathy 87.4% of the time and the absence of more than mild diabetic retinopathy 89.5% of the time. Use is contraindicated in patients with a history of laser treatment, surgery, or injections in the eye and those with persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe nonproliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion. It should not be used in pregnant patients.

Expanded approval of bupivacaine liposome injectable suspension (Exparel) to produce postsurgical regional analgesia following shoulder surgery in adults. The interscalene brachial plexus nerve block is intended to relieve pain for a period of 48 to 72 hours following administration. Approval was based on a multicenter clinical study that demonstrated the product's safety and effectiveness, but data are not sufficient to support use after operations other than shoulder surgery.

Marketing of the Dexcom G6 integrated continuous glucose monitoring system to determine blood glucose levels in adults with diabetes and children ages 2 and older. The patch device is the first to be approved for use with other diabetes devices, such as automated insulin-dosing systems, insulin pumps, or blood glucose meters. Two clinical studies with 324 participants compared blood glucose readings from the system to those from a laboratory test method. No serious adverse events were reported, but risks associated with the system include hypoglycemia or hyperglycemia in cases where device information is inaccurate and used to make treatment decisions or where configuration issues disable alarms and alerts. In addition, patients may experience skin irritation or redness around the patch site.

System 83 Plus automated endoscope reprocessors (AERs) by Custom Ultrasonics to process certain duodenoscopes. The FDA determined that the data show that the AERs can achieve high-level disinfection of the Olympus TJF-180V and Pentax ED-3490TK duodenoscopes. They are approved to be used with only these types of duodenoscopes.

Burosumab-twza (Crysvita), the first drug approved to treat patients with x-linked hypophosphatemia, an inherited form of rickets. In one trial, 94% of adults who received the orphan drug once a month achieved normal phosphorus levels, compared to 8% of those receiving placebo. The most common adverse reactions were back pain, headache, restless leg syndrome, decreased vitamin D levels, dizziness, and constipation.

Expanded approval of blinatumomab (Blincyto) to treat patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease. Efficacy was shown in a single-arm trial of 86 patients, 70 of whom achieved undetectable minimal residual disease. More than half of patients remained alive and in remission for at least 22.3 months. Common side effects include infections, fever, headache, infusion-related reactions, neutropenia, anemia, and thrombocytopenia. The drug carries a boxed warning about potential problems with cytokine release syndrome at the start of treatment, as well as other nervous system side effects like encephalopathy.

Dabrafenib (Tafinlar) and trametinib (Mekinist) to treat certain patients with anaplastic thyroid cancer. Administered together, the drugs are indicated to treat patients with unresectable or metastatic anaplastic thyroid cancer that is BRAF V600E mutation-positive. They were already approved, alone or in combination, to treat BRAF V600 mutation-positive metastatic melanoma and in combination to treat BRAF V600E mutation-positive metastatic non-small cell lung cancer. In an open-label trial that evaluated the drug combination in 23 patients with BRAF V600E mutation-positive cancers, 57% had a partial reduction in tumor size and 4% had a complete response, with 64% of responders avoiding significant tumor growths for six months or longer. Common side effects of the drug combination include fever, rash, chills, headache, joint pain, cough, fatigue, nausea, vomiting, diarrhea, myalgia, dry skin, decreased appetite, edema, hemorrhage, hypertension, and dyspnea. Both drugs can cause harm to a developing fetus.

First-time generic approvals

Ropivacaine hydrochloride injection USP, 0.2% (200 mg/100 mL and 400 mg/200 mL [2 mg/mL] single-dose infusion bottles) for local and regional anesthesia and acute pain management. (Brand name: Naropin)

Note: The FDA states that drugs are not always commercially available immediately after approval.