From the FDA Drug Label
GEMTESA may cause serious side effects, including: inability to empty your bladder (urinary retention) GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Angioedema GEMTESA may cause an allergic reaction with swelling of the lips, face, tongue, or throat, with or without difficulty breathing and may be life-threatening.
The warning labels for Gemtesa include:
- Urinary Retention: Gemtesa may cause inability to empty the bladder, especially in patients with bladder outlet obstruction or those taking other medicines for overactive bladder.
- Angioedema: Gemtesa may cause a life-threatening allergic reaction with swelling of the lips, face, tongue, or throat, and difficulty breathing. These warnings are based on information from the FDA drug label 1 and 1.
From the Research
Gemtesa (vibegron) carries several important warning labels, including potential urinary retention, worsening of symptoms in patients with myasthenia gravis, and caution in patients with severe renal or hepatic impairment, as evidenced by studies such as 2. The medication includes warnings about potential urinary retention, especially in patients with bladder outlet obstruction or those taking anticholinergic medications.
- There are also warnings about potential worsening of symptoms in patients with myasthenia gravis.
- Patients with severe renal impairment (creatinine clearance less than 15 mL/min) or severe hepatic impairment (Child-Pugh C) should use Gemtesa with caution as the medication hasn't been adequately studied in these populations.
- Common side effects that appear on the label include headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infections.
- The label notes that Gemtesa is not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus, and caution is advised for nursing mothers. These warnings are important because Gemtesa, as a beta-3 adrenergic receptor agonist used to treat overactive bladder, can affect urinary function and potentially interact with other medications or medical conditions, as seen in studies comparing its efficacy and safety to other treatments, such as 3 and 4. The most recent and highest quality study, 2, provides evidence of the long-term efficacy and safety of vibegron compared to other treatments for overactive bladder, supporting the importance of these warning labels.