ALZHEIMER DISEASE
First drug to image tau pathology approved
Tauvid (flortaucipir F18) is the first drug approved by the FDA to help image a distinctive characteristic of Alzheimer disease called tau pathology. Administered via I.V. injection, Tauvid is a radioactive diagnostic agent for adults with cognitive impairment who are being evaluated for Alzheimer disease. Tauvid is used during positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles, a primary marker of Alzheimer disease.
Alzheimer disease, which is characterized by misshapen tau and amyloid proteins, can be definitively diagnosed only after death. Three imaging drugs have previously been approved to help detect postmortem amyloid pathology; Tauvid is the first drug approved that can help clinicians detect tau pathology in living patients.
Tauvid binds to sites in the brain associated with abnormal tau proteins, revealing tau pathology on PET. In clinical trials, its ability to detect tau pathology was primarily assessed in terminally ill patients with severe dementia. The FDA cautions that it may be less effective for detecting pathology in patients in earlier stages of cognitive decline.
The most common adverse reactions in the clinical trials were headache, injection-site pain, and increased BP.
Source: US Food and Drug Administration. FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer's disease. News release. May 28, 2020.
HAND SANITIZERS
Beware of unproven or fraudulent claims
The FDA is warning consumers about safety concerns related to the marketing of hand sanitizers that do not meet FDA standards. To ensure the availability of hand sanitizers during the COVID-19 pandemic, the FDA has encouraged manufacturers to produce more products. Consequently, more than 1,500 additional manufacturers have registered with the FDA to produce hand sanitizers. However, some of these products are potentially unsafe because they do not contain denatured alcohol as normally required by the FDA. Denatured alcohol makes the sanitizer bitter-tasting and less appealing to children. Drinking even a small amount of hand sanitizer could be fatal to a young child.
In addition, some products are being promoted for unproven benefits. For example, one product claims to "protect you from pathogens up to 24 hours or for 10 hand washes." No evidence has shown that hand sanitizers can protect consumers for 24 hours or after multiple hand washings, the FDA says, nor have any of these products been proven as treatments for COVID-19. Unproven claims may give consumers a false sense of security, leading to less frequent hand hygiene.
Warn patients to beware of products promoted with potentially fraudulent advertising. Report products being unlawfully sold on the internet to the FDA at http://www.fda.gov/safety/report-problem-fda.
Source: US Food and Drug Administration. Coronavirus (COVID-19) update: FDA continues to ensure availability of alcohol-based hand sanitizer during the COVID-19 pandemic, addresses safety concerns. News release. April 27, 2020.
RECARBRIO
Combination antibiotic approved to treat VAP
Recarbrio (a combination of imipenem-cilastatin and relebactam) has been approved by the FDA to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients age 18 and older. Recarbrio was previously approved to treat complicated urinary tract infections and complicated intra-abdominal infections in patients who have limited or no alternative treatment options.
The approval was based on results of a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due to Gram-negative bacteria in which 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam. Overall, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam died through Day 28 of the study.
Recarbrio is administered I.V. Adverse reactions include elevated liver enzymes, anemia, diarrhea, hypokalemia, and hyponatremia. Before initiating therapy with Recarbrio, clinicians must assess patients for previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. Recarbrio should not be used in patients who are prone to seizures and other central nervous system disorders. Like other antibiotics, Recarbrio may cause Clostridioides difficile-associated diarrhea.
Source: US Food and Drug Administration. FDA approves antibiotic to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. News release. June 4, 2020.
PARKINSON DISEASE
Evidence is insufficient to recommend cannabis
In a consensus statement, the Parkinson's Foundation states that more rigorous research is needed on the safety and effectiveness of medical cannabis to treat nonmotor symptoms of Parkinson disease (PD) such as sleep disturbances, pain, and anxiety. Pointing to a lack of clear data on adverse reactions, toxicity, and interactions with PD medications, the authors do not recommend the use of cannabis products to manage PD symptoms or modify disease progression. However, given that many patients with PD want to try cannabis products, the authors provide guidance for both general safety and working with dispensaries. Review the full statement at http://www.parkinson.org.
Source: Parkinson's Foundation. Parkinson's Foundation consensus statement on the use of medical cannabis for Parkinson's disease. 2020.
L-THYROXINE
No symptom relief for older adults with SCH
In a secondary analysis of a randomized trial, L-thyroxine did not improve fatigue or other hypothyroid symptoms in patients age 60 and older with persistent subclinical hypothyroidism (SCH) and high symptom burden. Over a year, 638 participants received L-thyroxine or matching placebo with mock dose titration. Measurements were the 1-year change in Hypothyroid Symptoms and Tiredness scores on a standardized quality-of-life questionnaire. These scores range from 0 to 100, with higher scores indicating a heavier symptom burden. Comparisons were made between participants with high symptom burden (baseline Hypothyroid Symptoms score greater than 30 or Tiredness score greater than 40) and those with lower symptom burden.
Among the participants, 132 had high symptom burden. In this group, improvement in the Hypothyroid Symptoms score was similar in those receiving L-thyroxine and those receiving placebo. Researchers found no evidence that the baseline Hypothyroid Symptoms score or Tiredness score modified the effects of L-thyroxine versus placebo. They concluded, "In older adults with SCH and high symptom burden at baseline, L-thyroxine did not improve hypothyroid symptoms or tiredness compared with placebo."
Source: de Montmollin M, Feller M, Beglinger S, et al. L-Thyroxine therapy for older adults with subclinical hypothyroidism and hypothyroid symptoms: secondary analysis of a randomized trial. Ann Intern Med. [e-pub May 5, 2020]