Catheters, infusion pumps recalled

Recalls

A class I recall of certain infusion pumps and systems by Baxter Healthcare due to unplanned shutdown issues. The recall includes Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library versions 6 and 8 and Spectrum IQ Infusion Systems with Dose IQ Safety Software. Improper cleaning of the devices may lead to residue buildup or corrosion, and if the device is running only on battery power, this may lead to an unplanned shutdown without warning. There have been 17,493 complaints about this issue and 16 reports of serious injuries. There have been no reported deaths. The recall includes more than 550,000 devices distributed from July 1, 2008, to July 14, 2020.

A class I recall of Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers by Cook Medical due to an increased chance of device separation. There have been 57 complaints about this issue and 14 reports of serious injuries. There have been no reported deaths. The recall includes 37,326 devices distributed from May 23 to Nov. 17, 2020.

A letter to clinicians about an urgent recall of all configurations of the JET 7 Reperfusion Catheter with Xtra Flex Technology by Penumbra due to an increased risk of unexpected death or serious injury when used for removing clots in stroke patients. The FDA has received more than 200 associated medical device reports, including deaths, serious injuries, and malfunctions. The recall includes the JET 7 Xtra Flex catheter and the JET 7MAX configuration but does not apply to the JET 7 Reperfusion Catheter with Standard Tip. All clinicians should stop using this device, and facilities should remove it from inventory, according to the recall.

An expanded recall of chlorhexidine gluconate oral rinse USP (Paroex; 0.12% in 15-mL unit dose cups), by Sunstar Americas Inc., to include expiration dates from Dec. 31, 2020, to Sept. 30, 2022, due to possible microbial contamination with Burkholderia lata. The initial recall was announced last October, and 29 related adverse events have been reported to the manufacturer. In response to this recall, Precision Dose Inc. recalled all lots of its repackaged products bearing an expiration date from Jan. 31, 2021, to Feb. 28, 2022.

A recall of one lot of anagrelide capsules USP (1 mg) by Torrent Pharmaceuticals due to dissolution test failure detected during routine quality testing. Recalled products were distributed nationwide to a wholesale distributor and retail customers. No adverse events have been reported.

A recall of one lot of sildenafil tablets (100 mg) and one lot of trazodone tablets (100 mg) by AvKARE due to a product mix-up. The two separate products were inadvertently packaged together during bottling at a third-party facility. They were sent out to distributors and wholesalers, then further distributed nationwide. No adverse events have been reported.

An expanded recall of metformin hydrochloride extended-release tablets USP (750 mg) by Nostrum Laboratories Inc. to include an additional lot due to nitrosamine impurities. Recalled products were found to contain excess levels of N-nitrosodimethylamine, a probable carcinogen.

A recall of one lot of Soho Fresh 70% Rubbing Alcohol by Essaar Inc. due to contamination with methanol. An FDA analysis revealed the contamination, which poses a risk of methanol poisoning, particularly among young children who accidently ingest these products and adolescents and adults who drink them as a substitute for alcohol (ethanol). No related adverse events have been reported. Recalled products were distributed nationwide to retail stores.

A recall of one lot each of imc Wash-Free Hand Sanitizer (50 mL, 100 mL, and 300 mL), Wash-Free Hand Sanitizer (300 mL), and Thrifty White Pharmacy Wash-Free Hand Sanitizer (300 mL) by Shane Erickson Inc., doing business as Innovative Marketing Solutions, due to the potential presence of undeclared methanol. No related adverse events have been reported. Recalled products were distributed nationwide to wholesale and retail customers.

Miscellaneous

A safety communication informing patients and clinicians that patients may be injured if they wear face masks with metal parts and coatings during an MRI exam. Metal parts (e.g., nose pieces), nanoparticles, or antimicrobial coating that may contain metal (e.g., silver, copper) may become hot and burn the patient during the exam. The FDA has received at least one report that a patient's face was burned from the metal in a face mask worn during an MRI.

An updated safety communication on the use of laparoscopic power morcellation for gynecologic procedures. Last December, the FDA issued final guidance on product labeling for laparoscopic power morcellators, providing recommendations concerning the content and format to better inform patients and clinicians of the devices' risks.

COVID-19 updates

An emergency use authorization (EUA) allowing the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S. to individuals ages 16 years and older. Safety and effectiveness data to support the EUA include analyses of more than 36,000 participants enrolled in an ongoing, randomized, placebo-controlled international study. The vaccine was 95% effective in preventing COVID-19 disease, with eight cases in the vaccine group and 162 in the placebo group. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. More people experienced these side effects after the second dose than after the first dose.

An EUA allowing the Moderna COVID-19 Vaccine to be distributed in the U.S. to individuals ages 18 years and older. Safety and effectiveness data to support the EUA include analyses of more than 28,000 participants enrolled in an ongoing, randomized, placebo-controlled study conducted in the U.S. The vaccine was 94.1% effective in preventing COVID-19 disease, with 11 cases in the vaccine group and 185 in the placebo group. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. More people experienced these side effects after the second dose than after the first dose.

An EUA for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The antigen test is authorized for use at home with self-collected nasal swab samples in individuals ages 15 years and older in whom a clinician suspects COVID-19 within the first seven days of symptom onset. The test is also authorized in individuals ages 4 years and older when an adult collects the sample. The test is being offered in partnership with a telehealth service that will take users step by step through the sample-collection process, explain how to perform the test, and assist in reading and understanding the results.

An EUA for the Ellume COVID-19 Home Test, an over-the-counter, at-home rapid diagnostic test for COVID-19. The antigen test is authorized for individuals ages 2 years and older, with or without symptoms. It can be used completely at home without a prescription and requires the use of a compatible smartphone and a downloadable app to provide testing instructions and deliver results in 20 minutes.

Authorization of the first diagnostic test for at-home collection of patient samples to detect both COVID-19 and influenza A and B. The FDA authorized the Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with a self-collection kit by individuals with suspected respiratory viral infection consistent with COVID-19 when a clinician determines home collection to be appropriate. Under a clinician's order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis, following the instructions included with the kit.

An EUA for the Pixel COVID-19 Test Home Collection Kit for use with LabCorp's COVID-19 RT-PCR Test. The kit, which does not require a prescription, allows patients ages 18 and older to self-collect a nasal sample at home and then send the sample to LabCorp for testing. A clinician then delivers positive or invalid test results to the user by phone call, while users may access negative test results through an online portal or by email.

An EUA for the Lumin LM3000 Bioburden Reduction UV System. The system is the first ultraviolet-C light-based bioburden reduction system for emergency use in bioburden reduction of certain N95 respirators when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic.

Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency. These medications include heparin sodium injection, etomidate injection, furosemide injection, midazolam injection, dexmedetomidine hydrochloride in 0.9% sodium chloride injection, and succinylcholine chloride injection USP (200 mg/10 mL).

A letter alerting clinicians and clinical laboratory staff that the FDA is monitoring the potential impact of SARS-CoV-2 viral mutations, including the emerging B1.1.7 variant, on authorized SARS-CoV-2 molecular tests. False-negative results can occur with any molecular test for the detection of the virus if a mutation occurs in the part of the virus' genome assessed by that test. The FDA said it believes the risk that these mutations will impact overall testing accuracy is low. To ensure tests remain accurate, the agency is working with test developers and conducting ongoing data analysis to evaluate all currently authorized molecular tests.

A safety communication about the risk of false results, particularly false negatives, with the Curative SARS-Cov-2 test. To reduce the risk of false-negative results, it is important to perform the real-time reverse-transcriptase polymerase chain reaction test in accordance with its EUA and as described in the test's authorized labeling, the FDA said.

Approvals

Relugolix (Orgovyx) for the treatment of adult patients with advanced prostate cancer. The oral hormone therapy works by blocking the pituitary gland from making luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make. In a randomized, open-label trial, 96.7% of 622 men with advanced prostate cancer who received the drug achieved and maintained low enough levels of testosterone. The most common side effects include hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of certain liver enzymes.

A new indication for osimertinib (Tagrisso) as the first adjuvant treatment for patients with non-small-cell lung cancer whose tumors have a specific type of genetic mutation. In a randomized, double-blind trial of 682 patients with early stage non-small-cell lung cancer and epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations who had undergone complete tumor removal, those who received the drug had an 80% decrease in disease recurrence compared with patients who received placebo. The most common side effects include diarrhea, rash, musculoskeletal pain, dry skin, skin inflammation around nails, sore mouth, fatigue, and cough. The orphan drug was previously approved in 2018 for the first-line treatment of patients with metastatic non-small-cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.

The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System. The prosthetic implant is the first implant system marketed in the U.S. for adults who have had above-the-knee amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The OPRA system is surgically anchored and integrated into the patient's remaining thigh bone to allow connection to an external prosthetic limb. In a study of 65 participants who received the system, the average improvement in prosthetic-use score, on a 100-point scale, was 35.1 points at two years and 39.6 points at five years compared with their reported scores with a conventional socket prosthesis. Adverse events included infection, mechanical complications, pain, injury, and loosening of the fixture.

Marketing of a new resorbable implant to repair a torn anterior cruciate ligament (ACL). The Bridge-Enhanced ACL Repair Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently available alternative to reconstruction with allograft, autograft, or suture-only repair for the treatment of ACL rupture. It is indicated for skeletally mature patients ages 14 years and older with a complete rupture of the ACL, as confirmed by MRI. In a randomized controlled trial of 100 participants with complete ACL rupture, 65 patients received the implant and 35 received ACL reconstruction with autograft. At two years, those who received the implant reported an average score of 88.6 on the International Knee Documentation Committee Subjective Score, while patients in the control group reported an average score of 84.6. Complications observed in the study included graft or repair failure and the need for additional surgical procedures.

Marketing of a new device designed to remove dead pancreatic tissue. The EndoRotor System is the first device indicated to treat patients with walled-off pancreatic necrosis resulting from complications of acute pancreatitis. In a trial of 30 participants with walled-off pancreatic necrosis who were indicated to undergo a direct endoscopic necrosectomy with the system, there was an average of 85% reduction in the amount of necrotic tissue, with half of the subjects having 98.5% clearance of their necrotic tissue. On average, participants required about two procedures each. In the trial, three participants experienced procedure-related serious adverse events (two had GI bleeding, while the third experienced a pneumoperitoneum and later died). Other serious adverse events included hematemesis, deep venous thrombosis, and pancreatitis. The system should not be used in patients with known or suspected pancreatic cancer, and a boxed warning will emphasize this point.

First-time generic approvals

Glucagon for injection USP (1 mg/vial packaged in an emergency kit) for the treatment of severe hypoglycemia and for use as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when reduced intestinal motility would be advantageous. (Brand name: Glucagen)

Nitazoxanide tablets (500 mg) for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. (Brand name: Alinia)

Brinzolamide ophthalmic suspension USP (1%) for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (Brand name: Azopt)

Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules (1 mg/20 µg) for use by women to prevent pregnancy. (Brand name: Taytulla)

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