Recalls and alerts
An alert that biotin (vitamin B7) can interfere with certain lab tests and cause clinically significant incorrect test results. An increasing number of related adverse events, including one death, have been reported. A patient was taking high levels of biotin and died following falsely low troponin results on a test known to have biotin interference. The FDA recommends asking patients if they are taking any biotin supplements, including those marketed for hair, skin, and nail growth.
A new class warning and other safety measures for gadolinium-based contrast agents used in magnetic resonance imaging. The FDA believes the benefits of these contrast agents outweigh the risks but is concerned that gadolinium is retained in patients' bodies, including the brain, for months to years after administration. In addition to requiring a new patient medication guide, which patients will be asked to read before receiving a gadolinium-based contrast agent, the FDA is also requiring manufacturers of the contrast agents to conduct safety studies in humans and animals.
An alert about potentially increased risk of heart-related death with febuxostat (Uloric) compared to allopurinol, based on preliminary results from a postmarketing safety trial of more than 6,000 patients that the FDA required the manufacturer to conduct. The agency will provide an update after it reviews the final results.
A recall of one lot of amiodarone hydrochloride 150 mg/100 mL premixed injection (Nexterone) by Baxter due to the presence of particulate matter. The affected lot was distributed nationwide between Aug. 23 and Oct. 2, 2017.
Once-monthly injectable buprenorphine (Sublocade) to treat moderate to severe opioid use disorder. The drug is indicated for adults who have been on a stable dose of transmucosal buprenorphine for at least seven days. In clinical trials, patients who received the drug had more weeks without positive urine tests or self-reports of opioid use than those who received placebo. The most common side effects were constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching at the injection site, and abnormal liver function tests. A boxed warning includes information about the risks of intravenous rather than subcutaneous administration, such as occlusion, tissue damage, and embolus. The drug will be provided to clinicians through a restricted program and will be administered only by health care professionals.
Dolutegravir and rilpivirine (Juluca), the first two-drug regimen for certain patients with HIV. The fixed-dose tablet is indicated for adults with HIV-1 infection whose virus is suppressed on a stable regimen for at least six months, with no history of treatment failure. A trial of 1,024 patients found that those who switched to the regimen from their current anti-HIV drugs had virus suppression comparable to those who continued their current regimen. The most common side effects were diarrhea and headache, and serious side effects include skin rash and allergic reactions, liver problems, and depression or mood changes. The drug should not be given with other anti-HIV drugs and may have drug interactions with other medications.
A new indication for an electric stimulation device to help reduce the symptoms of opioid withdrawal. The device, called the NSS-2 Bridge, is a small electrical nerve stimulator placed behind the ear. Using a battery-powered chip that emits electrical pulses, the device stimulates branches of certain cranial nerves to provide relief from withdrawal symptoms. Patients may use the device for up to five days during the acute physical withdrawal phase. In a single-arm study of 73 patients undergoing physical withdrawal, all patients had a 31% or more reduction in Clinical Opiate Withdrawal Scale score within 30 minutes of using the device. Overall, 64 of 73 patients (88%) transitioned to medication therapy after five days of device use. The device, formerly known as the electro auricular device, was initially approved in 2014 for use in acupuncture. It is available by prescription only and is contraindicated in patients with hemophilia, cardiac pacemakers, and psoriasis vulgaris.
A finalized rule that 24 active ingredients can no longer be used in over-the-counter health care antiseptic products because they are not generally recognized as safe and effective. Of all the banned ingredients, triclosan is the only one that is currently being used in these products, which include hand washes and rubs for health care personnel, surgical hand scrubs and rubs, and patient antiseptic skin preparations. Manufacturers have one year to comply with the rule by either reformulating their products or removing them from the market. The FDA has deferred final rulemaking by one year for six other active ingredients that are more commonly used: alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol.
New websites for clinicians to get updated information on antimicrobial susceptibility breakpoints. In an effort to help clinicians make more informed prescribing decisions, dedicated web pages will share and update information on FDA-recognized breakpoints for both antibacterial agents and antifungal agents.