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 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.
Etanercept-szzs (Erelzi), a biosimilar to etanercept (Enbrel), to treat multiple inflammatory diseases. Administered by injection, the drug is approved to treat certain patients with moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, and chronic moderate to severe plaque psoriasis.
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 a tissue plasminogen activator (tPA). 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.
A rule removing 19 specific active ingredients, including triclosan and triclocarban, from over-the-counter antibacterial hand and body washes. Some data have suggested that long-term exposure may pose health risks, such as bacterial resistance or hormonal effects. Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers have not demonstrated that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of infection. The rule doesn't apply to consumer hand sanitizers or wipes or to antibacterial products used in health care settings.