FDA requires labeling changes for benzodiazepines
A boxed warning on the entire class of benzodiazepine drugs has been updated by the FDA to include abuse, misuse, addiction, physical dependence, and withdrawal reactions to help improve the safe use of this class of drugs. In a statement, the agency said that while benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medications, alcohol, and illicit drugs.
The measure is being taken to require new labeling information to help healthcare providers and patients better understand that although benzodiazepines have many treatment benefits, these drugs also carry an increased risk of abuse, misuse, addiction, and dependence.
In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from US outpatient pharmacies. Alprazolam was the most common (38%), followed by clonazepam (24%), and lorazepam (20%).
Once-daily single inhaler triple therapy approved for treatment of asthma and COPD
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) has been approved by the FDA as the first once-daily single inhaler triple therapy for the treatment of both asthma and chronic obstructive pulmonary disease (COPD) in patients age 18 years and older. The drug is not approved for relief of acute bronchospasm.
The new indication for the treatment of asthma is in addition to a previous approval for use in patients with COPD. The FDA based its approval for the additional indication on data from a study showing that in patients uncontrolled on inhaled corticosteroids/long-acting beta agonist combination therapy, the additional bronchodilation provided by Trelegy demonstrated significant improvements in lung function compared with fluticasone furoate/vilanterol, and is available in a single daily dose, easy-to-use inhaler.
FDA approves two additional dosages of dulaglutide for T2DM
The FDA has approved two additional dosages (3 mg and 4.5 mg) of Trulicity (dulaglutide), Eli Lilly's once-weekly treatment for type 2 diabetes mellitus (T2DM). The approval was based on clinical trial data showing that the additional doses led to further benefits in blood glucose control and body weight reduction compared with dulaglutide 1.5 mg in people with T2DM.
In the trial, participants were started on a dose of 0.75 mg once weekly and were titrated up in a stepwise manner to a final randomized dose of 1.5 mg, 3 mg, or 4.5 mg. The company states that the availability of additional doses of dulaglutide may benefit patients who have been using the medication but need dose adjustments as the disease progresses.
All doses carry the same boxed warning for risk of thyroid C-cell tumors.
Oral solution of tramadol approved for management of severe pain
The FDA approved QDOLO (tramadol hydrochloride) oral solution 5 mg/mL (Schedule IV controlled substance [C-IV]), an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. QDOLO allows flexibility to titrate dosing precisely according to individual patients' needs and is an alternative for patients who have trouble swallowing pills.
Due to the risks of addiction, abuse, and misuse with opioids—even at recommended doses—QDOLO should be reserved for use in patients for whom alternative treatment options (such as nonopioid analgesics) have not been tolerated, are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia.
The most common adverse reactions reported in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, and pruritus. QDOLO is a product of Athena Bioscience.