Recalls and warnings
New boxed warnings for opioid pain and cough medicines and benzodiazepines that reflect the serious risks of combined use, which include slowed breathing and death. The FDA is also requiring revisions to other parts of the labeling, including the warnings and precautions section. Clinicians should limit prescribing opioids with benzodiazepines or other central nervous system depressants only to patients without alternative treatment options.
A recall of 3 lots of acetylcysteine (Cetylev) effervescent tablets for oral solution (500 mg) due to an inadequate seal of the blister pack. An improper seal can lead to a potentially subtherapeutic dose or microbial contamination, which could increase risk of liver injury, as the medication is indicated as an antidote for acetaminophen overdose.
A recall of 1 lot of oxacillin for injection (10 g) by Sagent Pharmaceuticals due to the presence of particulate matter. The matter found in the solution was identified as iron oxide, which, if administered to a patient, could result in local swelling, irritation of blood vessels or tissue, or blockage of blood vessels.
An expanded recall to include specific lots of cloth produced by Sage Products due to potential contamination with Burkholderia cepacia. Recalled products include the following single-use, disposable cloths distributed between August 2014 and August 2016: Comfort Shield Barrier Cream Cloths, Incontinence Clean-Up Cloths, M-care Meatal Cleansing Cloths for the Foley Catheterized Patient, Comfort Bath Cleansing Washcloths, and 2% Chlorhexidine Gluconate Cloths.
A recall of 6 batches of glucagon for injection (GlucaGen HypoKit) due to 2 international reports of detached needles on the syringe. An estimated 4 out of the 71,215 pens being recalled may be defective.
A recall of 1 lot of lamotrigine (200-mg orally disintegrating tablet) by Impax because of incorrect labeling of blister cards. Unit-of-use blister packs may contain 100 mg of the product instead of the intended 200 mg, so it is possible that patients could take less than their intended dose.
A recall of 7 batches of hyoscyamine sulfate (0.125 mg) tablets due to both superpotent and subpotent test results. All batches were manufactured by Pharmatech LLC and distributed by Virtus, which has received 3 reports of adverse events involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation.
A recall of all liquid drug and dietary supplement products produced by PharmaTech LLC, from Oct. 20, 2015, through July 15, 2016, because of a risk of product contamination with B. cepacia. There have been no reports of adverse events.
A recall of all lots of lyophilized human chorionic gonadotropin (HCG) and sermorelin aseptically compounded and packaged by Talon Compounding Pharmacy. Products were distributed to patients and clinicians nationwide between Jan. 18 and July 18, 2016. There have been no related reports of illness or injury, but the FDA has expressed concerns about a lack of sterility assurance because the process of lyophilizing HCG and sermorelin has not been verified.
A recall of NucliSENS easyMAG magnetic silica for nucleic acid extraction because of potentially inaccurate test results. Kits with the affected lots of magnetic silica have shown a decrease of extraction performance with certain downstream applications, and this detection problem could lead to false-negative or invalid lab test results. The recall includes 1,892 units distributed nationwide.
A safety communication recommending against the use of ovarian cancer screening tests. The use of these tests is linked to risks, such as false-positive or false-negative results. Current evidence suggests that no ovarian cancer screening tests are sensitive enough to accurately and reliably screen. Instead of recommending or using these tests, physicians could consider referring high-risk women to a genetic counselor or gynecologic oncologist for more specialized care.
A new indication for Trevo clot retrieval devices as an initial therapy for ischemic stroke to reduce paralysis, speech difficulties, and other stroke disabilities. The devices should be used within 6 hours of symptom onset and only following treatment with tissue plasminogen activator (tPA). The device was first cleared by the FDA in 2012 for clot removal and restoration of blood flow in stroke patients who could not receive tPA or did not respond to it. The FDA evaluated data from a clinical trial showing that 29% of patients treated with tPA, medical management, and the device were functionally independent 3 months after stroke, compared to 19% of those who received only tPA and medical management. Risks associated with the device include a failure to retrieve the blood clot, device malfunctions, and navigation difficulties, which may damage blood vessels and cause perforation or hemorrhage.
A new indication for 2 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. About one-third of patients referred for aortic valve replacement are at intermediate risk, defined as a 3% or more risk of dying within 30 days after surgery. The Sapien XT and Sapien 3 valves were previously approved only for patients at high risk for death or complications during surgery. Despite showing safety and effectiveness in clinical trials, the devices pose serious risks, such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.
The VisuMax Femtosecond Laser to surgically treat nearsightedness in certain patients 22 years and older. A clinical trial found that the device is safe and effective at correcting nearsightedness, with stable vision correction lasting through 6 months. Common complications included difficulty removing corneal tissue during surgery, dry eyes, glares, and halos.