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.
An alert about a previous class I recall of the Monteris Medical NeuroBlate probe, which is part of the NeuroBlate System. The manufacturer issued three advisories in 2017 as part of the recall, but the FDA is concerned that the information provided has not sufficiently mitigated the risk of unintended heating of the probe tip, which may have resulted in unintended damage to surrounding brain tissue in some cases. The FDA and manufacturer are working to address these concerns.
A recall of certain Alka-Seltzer Plus products due to a labeling error. Affected products may have different ingredients listed on the front sticker of the carton than those listed on the back label. Products included in the recall were sold in the U.S. at Walmart, CVS, and Kroger stores after Feb. 9, 2018, and can be identified by the Bayer logo on the bottom left of the front label: those with green and orange backgrounds are included in the recall.
A class I recall of the Certitude Delivery System by Edwards LifeSciences due to a molding overflow defect in the button valve within the loader. The overflow material could detach during system placement and may embolize into the patient. Recalled products were distributed between Jan. 9 and July 17, 2017.
A warning to Becton Dickinson (BD) & Company citing several violations of federal law. During an inspection of BD's New Jersey facility, the FDA found that the company marketed significantly modified versions of certain BD Vacutainer blood collection tubs without required agency clearance or approval, as well as failed to submit medical device reports within the required timeframe. The inspection was part of an ongoing investigation into the root cause of inaccurate blood lead test results associated with Magellan's LeadCare test systems.
An alert that BD is no longer using problematic rubber stopper material associated with loss of drug potency in its general use syringes. The company has returned to using a rubber stopper it had previously used in the syringes.
A recall of one lot of pantoprazole sodium for injection 40 mg/vial due to the presence of glass in a single vial. The lot was distributed nationwide to hospitals and wholesalers.
A recall of two lots of metformin hydrochloride oral solution (Riomet) by Sun Pharmaceutical Industries due to fungal contamination. The affected lots were contaminated with Scopulariopsis brevicaulis, posing infection risks, most likely in the respiratory tract and in immunocompromised patients.
A recall of 14 lots of diphenoxylate hydrochloride and atropine sulfate tablets by Greenstone due to potency concerns. Batches recalled due to potential subpotency or superpotency were distributed nationwide between November 2016 and June 2017. No related adverse events have been reported.
A recall of three lots of Pharmacist Choice Alcohol Prep Pads due to a lack of sterility assurance and other quality issues. Affected products, manufactured by Foshan Flying Medical Products Co. Ltd., were distributed between Oct. 18, 2016, and July 19, 2017.
A product advisory that 50- and 100-mL vials of albumin (human) 25% solution (AlbuRx 25) may have fading print on the label. The manufacturer, CSL Behring, is taking no action with products on the market but will address the print settings for future products. It recommends inspecting vial labels for readability and fading and, if necessary, referring to the carton for the lot number and expiration date.
A firmware update to certain implantable cardiac devices by Abbott to improve battery performance and reduce the risk of exploitation of cybersecurity vulnerabilities. The software 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 to only clinicians and facilities that provide information to patients about the device's risks and benefits.
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 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.
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.
Expanded approval of olaparib tablets (Lynparza) to treat patients with certain types of breast cancer whose tumors have a specific inherited genetic mutation. The drug is the first to be approved to treat certain patients with metastatic breast cancer who have a BRCA mutation. Patients are selected for treatment with the drug based on an FDA-approved genetic test, the BRACAnalysis CDx. In a randomized trial of 302 patients, median progression-free survival for patients taking the drug was seven months, compared to 4.2 months for patients receiving chemotherapy only. Common side effects include anemia, neutropenia, nausea, fatigue, and vomiting, and severe side effects include acute myeloid leukemia and pneumonitis.
The first tests to screen blood donors for the tickborne parasiteBabesia microti. The Imugen B. microti Arrayed Fluorescent Immunoassay detects antibodies to B. microti in human plasma samples, and the Imugen B. microti Nucleic Acid Test detects B. microti DNA in human whole blood samples.
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.