FDA approves first digital inhaler with sensor
The FDA approved Teva's albuterol sulfate (ProAir Digihaler) inhalation powder for the treatment or prevention of bronchospasm in patients age 4 years and older with reversible obstructive airway disease and for prevention of exercise-induced bronchospasm in patients 4 years and older. This is the first digital inhaler with built-in sensors that detect inhaler use and send the data to the companion mobile app, providing data on inhaler use to patients with asthma and chronic obstructive pulmonary disease.
The data are then sent to the device's app via Bluetooth technology so patients can review the data and share with their healthcare providers. Albuterol sulfate is supplied as a breath-actuated dry powder inhaler that contains 200 actuations. The ProAir Digihaler will be available commercially in 2020; however, Teva is making it available in 2019 through a small number of early experience programs to compile usage data.
Tosymra approved for acute treatment of migraine
The FDA approved sumatriptan nasal spray (Tosymra) for the acute treatment of migraine with or without aura in adults. The intranasal spray contains 10 mg sumatriptan and is supplied as a ready-to-use, single-dose, disposable unit. Sumatriptan nasal spray is a product of Promius Pharma.
Sumatriptan nasal spray was found to be safe, effective, and well tolerated in acute treatment of episodic migraine in a multicenter, double-blind, randomized, placebo-controlled study involving 107 patients. A significantly greater proportion of study patients experienced 2-hour pain freedom with sumatriptan nasal spray versus placebo (43.8% versus 22.5%; P < .05). The study also found that treatment with sumatriptan nasal spray significantly alleviated patients' most bothersome symptoms better than placebo, which included nausea, photophobia, and phonophobia.
As with other sumatriptan products, sumatriptan nasal spray is contraindicated in patients with a history of coronary artery disease or coronary artery vasospasm; Wolff-Parkinson-White syndrome or dysrhythmias associated with other cardiac accessory conduction pathway disorders; history of stroke, transient ischemic attack, or hemiplegic or basilar migraine because these patients are at a higher risk for stroke; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; severe hepatic impairment; recent use within 24 hours of an ergotamine-containing medication, ergot-type medication, or other selective serotonin-agonists (5-hydroxytryptamine1 [5-HT1] receptor agonists; or concurrent or recent use within 2 weeks of a monoamine oxidase-A inhibitor.
Fluoroquinolones linked to increased risk of aortic aneurysm rupture
The FDA updated an earlier warning that its reviews found fluoroquinolone antibiotics can increase the risk of aortic dissection or rupture of an aortic aneurysm, which is a life-threatening medical emergency that can cause significant hemorrhage or death. The warning applies to both oral and injection fluoroquinolones. Fluoroquinolone antibiotics should not be used in patients at increased risk unless no other treatment options are available, the agency warns.
Healthcare providers should avoid prescribing fluoroquinolones to patients at increased risk, which includes those with a history of an aortic aneurysm or those who are at risk for an aortic aneurysm, such as patients with peripheral artery disease, hypertension, certain genetic conditions (such as Marfan syndrome and Ehlers-Danlos syndrome), and older adult patients.
All patients should be advised to seek immediate medical treatment for any symptoms associated with aortic aneurysm, and fluoroquinolone treatment should be stopped immediately if a patient reports adverse reactions suggestive of aortic aneurysm rupture or dissection. A new warning about this risk will be added to the prescribing information, and a patient medication guide will be issued for all fluoroquinolones.