Last Thursday I started a new medication for my kidneys, Myrbetriq and I’ll use their website to discuss what I find most important in their Prescribing Information. Before starting the medication, I go to their website to read all the side effects, when to call the doctor, when to go to the hospital and take a quick look at the Clinical Trials to see how many people drop out of the trial and what for. Another reason to look at trial information is to see who many were in the trial.
If you want to know all the information, there is plenty to read. I’ve read enough about Clinical Trials to know where to go to find the information I want. To read the entire or some of what Prescribing Information looks like, click here.
Areas I look at on the Prescribing Information.
WARNINGS AND PRECAUTIONS
Increases in Blood Pressure: Can increase blood pressure in adult or
pediatric patients. Periodically monitor blood pressure, especially in
hypertensive patients. MYRBETRIQ/MYRBETRIQ Granules are not
recommended in patients with severe uncontrolled hypertension. (5.1)
• Urinary Retention in Patients With Bladder Outlet Obstruction and in
Patients Taking Muscarinic Antagonist Drugs for Overactive Bladder:
Administer with caution in these patients because of risk of urinary
retention. (5.2)
• Angioedema: Angioedema of the face, lips, tongue, and/or larynx has
been reported with mirabegron. (5.3, 6.2)
ADVERSE REACTIONS
Most commonly reported adverse reactions with MYRBETRIQ
monotherapy in adult patients with OAB (> 2% and > placebo) were
hypertension, nasopharyngitis, urinary tract infection, and headache.
(6.1)
• Most commonly reported adverse reactions with MYRBETRIQ, in
combination with solifenacin succinate in adult patients with OAB
(> 2% and > placebo and > comparator), were dry mouth, urinary tract
infection, constipation, and tachycardia. (6.1)
• Most commonly reported adverse reactions with
MYRBETRIQ/MYRBETRIQ Granules in pediatric patients with NDO
(≥ 3%) were UTI, nasopharyngitis, constipation, and headache. (6.1)
WARNINGS AND PRECAUTIONS
The most frequent adverse events (0.2%) leading to discontinuation in Studies 1, 2, and 3 for the 25 mg or 50 mg dose were nausea, headache, hypertension, diarrhea, constipation, dizziness, and tachycardia.
Atrial fibrillation (0.2%) and prostate cancer (0.1%) were reported as serious adverse events by more than 1 patient and at
a rate greater than placebo.
I hope you take the time to look at one of your medication’s Prescribing Information. You may be surprised by what you read.
Please watch this short video to learn more about FDA product labeling
https://www.youtube.com/watch?v=E9irTyi8s5Q]
Melinda
References:
https://www.fda.gov/about-fda/oncology-center-excellence/how-do-i-use-prescription-drug-labeling
Click to access Myrbetriq_WPI.pdf
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