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 the affected devices, and facilities should remove them 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.
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.
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 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).
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.
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 the 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 a conventional socket prosthesis. Adverse events included infection, mechanical complications, pain, injury, and loosening of the fixture.
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.