Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Hypermethioninemia and cerebral edema in patients with CBS deficiency [see Warnings and Precautions (5.1)] .
Most common adverse reactions (> 2%) are: nausea and gastrointestinal distress, based on physician survey (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc.
at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
See 17 for PATIENT COUNSELING INFORMATION.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The assessment of clinical adverse reactions is based on a survey study of 41 physicians, who treated a total of 111 homocystinuria patients with Betaine Anhydrous for Oral Solution.
Adverse reactions were retrospectively recalled and were not collected systematically in this open-label, uncontrolled, physician survey.
Thus, this list may not encompass all types of potential adverse reactions, reliably estimate their frequency, or establish a causal relationship to drug exposure.
The following adverse reactions were reported (Table 1): Table 1: Number of Patients with Adverse Reactions to Betaine Anhydrous for Oral Solution by Physician Survey Adverse Reactions Number of Patients Nausea 2 Gastrointestinal distress 2 Diarrhea 1 "Bad Taste" 1 "Caused Odor" 1 Questionable pyschological 1 "Aspirated the powder" 1 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of Betaine Anhydrous for Oral Solution.
WARNINGS AND PRECAUTIONS 5.1 Hypermethioninemia in Patients with CBS Deficiency Patients with homocystinuria due to cystathionine beta-synthase (CBS) deficiency may also have elevated plasma methionine concentrations.
Treatment with Betaine Anhydrous for Oral Solution may further increase methionine concentrations due to the remethylation of homocysteine to methionine.
Cerebral edema has been reported in patients with hypermethioninemia, including patients treated with Betaine Anhydrous for Oral Solution [see Adverse Reactions (6.2)] .
Monitor plasma methionine concentrations in patients with CBS deficiency.
Plasma methionine concentrations should be kept below 1,000 micromol/L through dietary modification and, if necessary, a reduction of Betaine Anhydrous for Oral Solution dosage.
Like all medications, Betaine Anhydrous can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: