Recalls and alerts
A class I recall of all models of the 6 French Sherpa NX Active Guide Catheter by Medtronic due to separation and fragmentation. The recall includes 106,298 devices distributed from April 3, 2017, to April 4, 2019. The manufacturer has received five customer complaints, and no serious injuries or deaths were reported.
A recall of certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters by ICU Medical, Inc. due to the potential for small amounts of fluid to leak out of the air vents on the inline filters. Affected products were distributed nationwide.
A recall of all over-the-counter (OTC) ranitidine branded as Zantac (Zantac 150, Zantac 150 Cool Mint, and Zantac 75) by Sanofi due to the possibility of low levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen. In addition, Perrigo Company and Dr. Reddy's Laboratories Ltd. have recalled all pack sizes of ranitidine due to the possible presence of NDMA. Some OTC products may be labeled by Walgreens, Walmart, CVS, Target, and Kroger. The FDA's preliminary tests of alternatives to OTC ranitidine, such as famotidine, esomeprazole, and omeprazole, were not positive for NDMA. Patients taking prescription ranitidine who wish to stop should speak to their clinicians about other treatment options.
An alert from CSL Behring LLC regarding an error during packaging of antihemophilic factor/von Willebrand factor complex (Humate-P). Because the potency data were shifted downward on the folding box of the drug, the actual von Willebrand factor data could be misread as factor VIII potency data. Although positioned incorrectly, the printed potency values are correct.
A recall of LemonPrep tubes and single-use cups by Mavidon due to potential contamination with Burkholderia cepacia. The cleaning agent was distributed to hospitals in the U.S. and other countries from September 2017 to January 2019. One related adverse event in a neonate has been reported.
A recall of all sterile compounded drug products within expiry by Innoveix Pharmaceuticals, Inc. due to a lack of sterility assurance. The affected products are injectable human chorionic gonadotropin and injectable sermorelin with growth hormone-releasing peptide 2.
A recall of one lot of Johnson's Baby Powder by Johnson & Johnson Consumer Inc. due to an FDA test indicating the presence of subtrace levels of chrysotile asbestos contamination in samples from a bottle purchased from an online retailer. The manufacturer is conducting an investigation into the matter and is working with the FDA to determine the integrity of the tested sample and the validity of the test results.
A recall of certain lots of 10-mL sterile injectable vials of products by Viatrexx Bio Incorporated due to a lack of sterility assurance. The products were distributed to fewer than 32 U.S. practitioners for office use.
A safety communication about 11 cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. Named URGENT/11, the vulnerabilities may allow anyone to remotely take control of the medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent device function. The vulnerabilities exist in IPnet, a third-party software component that supports network communications between computers. Some versions of the following operating systems are affected: VxWorks (by Wind River), Operating System Embedded (by ENEA), INTEGRITY (by Green Hills), ThreadX (by Microsoft), ITRON (by TRON Forum), and ZebOS (by IP Infusion). Devices determined to be affected so far include an imaging system, an infusion pump, and an anesthesia machine. Clinicians should advise patients who use medical devices that may be affected and remind them to seek medical help immediately if they think operation or function of their device changed unexpectedly. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit these vulnerabilities is already publicly available.
A recommendation that health care facilities and duodenoscope manufacturers transition to duodenoscopes with disposable endcaps. While a full transition away from conventional duodenoscopes to innovative models will take time, health care facilities should develop plans to transition away from older models that have fixed endcaps and begin investing in newer, innovative models. While fully disposable duodenoscopes are not yet available, partially disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable/fixed endcaps.
First-time authorization of the marketing of smokeless tobacco products through the modified risk tobacco product pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name. The new authorization allows the manufacturer to market these specific products with the claim, “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The FDA made the authorization after reviewing scientific evidence submitted by the company that supports this claim. The modified risk orders are product-specific and limited to five years. However, the FDA has placed stringent advertising and promotion restrictions on the products, and the packaging and advertising must bear the warning statements required for all smokeless tobacco products.
Marketing of a rapid diagnostic test (OraQuick Ebola Rapid Antigen) to detect Ebola virus antigens. The test, which is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for Ebola virus disease, is indicated to detect Ebola virus antigens in certain living or recently deceased individuals suspected to have died of Ebola. It provides a rapid, presumptive diagnosis that must be confirmed by other procedures, such as by a more sensitive but less rapid polymerase chain reaction test. The availability of this test could help clinicians to more quickly isolate patients and begin potentially life-saving treatments, the FDA said. The test is intended to detect Ebola virus antigens in blood from patients with suspected Ebola virus disease, those with signs or symptoms consistent with the disease, and those who meet the CDC's Ebola virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Ebola virus disease transmission at the time of travel). It is not intended to be used for general Ebola infection screening (e.g., airport screening) or testing of individuals at risk of exposure without observable signs of infection. The test may also be used in oral fluids of recently deceased individuals who have epidemiological risk factors and whose deaths are suspected to be due to Ebola virus disease to inform decisions on safe handling of cadavers to prevent disease transmission.
Istradefylline (Nourianz) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing “off” episodes. An “off” episode is a time when a patient's medications are not working well, leading to disease symptoms (e.g., tremor, difficulty walking). Effectiveness was shown in four 12-week placebo-controlled studies in a total of 1,143 participants. In all four studies, patients treated with the drug experienced a significant decrease from baseline in daily “off” time compared to those receiving placebo. The most common adverse reactions were dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia. If hallucinations, psychotic behavior, or impulsive/compulsive behavior occurs, clinicians should consider a dosage reduction or discontinuation.
Lasmiditan (Reyvow) tablets for the acute treatment of migraine with or without aura in adults. The drug is not indicated for the preventive treatment of migraine. In two double-blind placebo-controlled trials, the percentages of patients whose pain resolved and whose most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved two hours after treatment were significantly greater in patients receiving the drug at all doses compared to those receiving placebo. The drug causes central nervous system (CNS) depression, including dizziness and sedation, and should be used with caution if taken in combination with alcohol or other CNS depressants. Patients should not drive or operate machinery for at least eight hours after taking it. The most common side effects are dizziness, fatigue, paresthesia, and sedation.
Emtricitabine, 200 mg, and tenofovir alafenamide, 25 mg, (Descovy) for HIV-1 pre-exposure prophylaxis in at-risk adults and adolescents weighing at least 35 kg, excluding those who have receptive vaginal sex. Effectiveness in individuals at risk of HIV-1 infection from receptive vaginal sex has not been evaluated. Safety and efficacy were evaluated in a randomized, double-blind, multinational trial in 5,387 HIV-negative men and transgender women who have sex with men and were at risk of HIV-1 infection. The drug was similar to emtricitabine-tenofovir disoproxil fumarate (200 mg/300 mg) in reducing the risk of acquiring HIV-1 infection. The most common adverse reaction was diarrhea. There is a boxed warning for patients who also have hepatitis B virus (HBV) about the risk of HBV exacerbation in those who discontinue products with emtricitabine or tenofovir disoproxil fumarate, which may also occur with stopping emtricitabine and tenofovir alafenamide. The drug is contraindicated in those with unknown or positive HIV-1 status and should only be prescribed to patients confirmed to be HIV-negative immediately prior to initiating and at least every three months during use. The drug was approved in 2016 in combination with other antiretrovirals to treat adults and pediatric patients with HIV-1 infection.
First-time generic approvals
Fosaprepitant for injection (115 mg) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin, and of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (Brand name: Emend)
Carfilzomib for injection (60-mg single-dose vial) for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. (Brand name: Kyprolis)
Vilazodone hydrochloride tablets (10 mg, 20 mg, and 40 mg) for the treatment of major depressive disorder. (Brand name: Viibryd)
Ivermectin cream (1%) for the treatment of inflammatory lesions of rosacea. (Brand name: Soolantra)
Posaconazole delayed-release tablets (100 mg) for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk due to being severely immunocompromised. (Brand name: Noxafil)
Triamterene capsules USP (50 mg and 100 mg) for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and the nephrotic syndrome, as well as to treat steroid-induced edema, idiopathic edema, and edema due to secondary hyperaldosteronism. (Brand name: Dyrenium)
Nabumetone tablets USP (500 mg, 750 mg, and 1,000 mg) to relieve signs and symptoms of osteoarthritis and rheumatoid arthritis. (Brand name: Relafen)
Halcinonide cream USP (0.1%) for the relief of inflammatory dermatoses. (Brand name: Halog)
Note: The FDA states that drugs are not always commercially available immediately after approval.