"July 22, 2015 -- New results from ongoing clinical trials have fueled hopes for a class of Alzheimer's drugs that target the buildup of sticky plaque in the brain linked to the disease.
The data, presented Wednesday to a standing-room-only "...
Serious adverse reactions are discussed in more detail in the following sections of the labeling:
- Serious skin reactions [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Conditions [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Conditions [see WARNINGS AND PRECAUTIONS]
- Genitourinary Conditions [see WARNINGS AND PRECAUTIONS]
- Neurological Conditions [see WARNINGS AND PRECAUTIONS]
- Pulmonary Conditions [see WARNINGS AND PRECAUTIONS]
- Deaths in subjects with mild cognitive impairment (MCI) [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the 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 most common adverse reactions in galantamine-treated patients from double-blind clinical trials ( ≥ 5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
The most common adverse reactions associated with discontinuation ( ≥ 1%) in galantamine-treated patients from double-blind clinical trials were nausea (6.2%), vomiting (3.3%), decreased appetite (1.5%), and dizziness (1.3%).
The safety of the extended-release capsule and immediate-release tablet formulations of galantamine was evaluated in 3956 galantamine-treated patients who participated in 8 placebo-controlled clinical studies and 1454 subjects in 5 open-label clinical studies with mild to moderate dementia of the Alzheimer's type. In clinical studies, the safety profile of once-daily treatment with extended-release galantamine was similar in frequency and nature to that seen with tablets. The information presented in this section was derived from pooled double-blind studies and from pooled open-label data.
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials
Table 1 lists the adverse reactions reported in ≥ 1% of galantamine-treated patients in 8 placebo-controlled, double-blind clinical trials.
Table 1: Adverse Reactions Reported by ≥ 1% of
Galantamine-Treated Patients in Pooled Placebo-Controlled, Double-Blind
|System/Organ Class Adverse Reaction||Galantamine
|Metabolism and Nutrition Disorders|
|Nervous System Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|General Disorders and Administration Site Conditions|
|Injury, Poisoning and Procedural Complications|
The majority of these adverse reactions occurred during the dose-escalation period. In those patients who experienced the most frequent adverse reaction, nausea, the median duration of the nausea was 5-7 days.
Other Adverse Reactions Observed in Clinical Trials of Galantamine
The following adverse reactions occurred in < 1% of all galantamine-treated patients (N=3956) in the above double-blind, placebo-controlled clinical trial data sets. In addition, the following also includes all adverse reactions reported at any frequency rate in patients (N=1454) who participated in open-label studies. Adverse reactions listed in Table 1 above were not included below:
Metabolism and Nutrition Disorders: Dehydration
Nervous System Disorders: Dysgeusia, Hypersomnia, Paresthesia
Eye Disorders: Blurred vision
Vascular Disorders: Flushing, Hypotension
Gastrointestinal Disorders: Retching
Skin and Subcutaneous Tissue Disorders: Hyperhidrosis
Musculoskeletal and Connective Tissue Disorders: Muscular weakness
Discontinuations Due to Adverse Reactions
In the 8 placebo-controlled studies of adults, 418 (10.6%) galantamine-treated patients (N=3956) and 56 (2.2%) placebo patients (N=2546) discontinued due to an adverse reaction. Those events with an incidence of ≥ 0.5% in the galantamine-treated patients included nausea (245, 6.2%), vomiting (129, 3.3%), decreased appetite (60, 1.5%), dizziness (50, 1.3%), diarrhea (31, 0.8%), headache (29, 0.7%), and decreased weight (26, 0.7%). The only event with an incidence of ≥ 0.5% in placebo patients was nausea (17, 0.7%).
In the 5 open-label studies, 103 (7.1%) patients (N=1454) discontinued due to an adverse reaction. Those events with an incidence of ≥ 0.5% included nausea (43, 3.0%), vomiting (23, 1.6%), decreased appetite (13, 0.9%), headache (12, 0.8%), decreased weight (9, 0.6%), dizziness (8, 0.6%), and diarrhea (7, 0.5%).
The following additional adverse reactions have been identified during post-approval use of RAZADYNE® ER and RAZADYNE®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency:
Immune System Disorders: Hypersensitivity
Psychiatric Disorders: Hallucinations
Nervous System Disorders: Seizures
Ear and Labyrinth Disorders: Tinnitus
Vascular Disorders: Hypertension
Hepatobiliary Disorders: Hepatitis, Increased hepatic enzyme
Read the Razadyne ER (galantamine hbr er) Side Effects Center for a complete guide to possible side effects
Use With Anticholinergics
Use With Cholinomimetics and Other Cholinesterase Inhibitors
A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol [see CLINICAL PHARMACOLOGY].
Read the Razadyne ER Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/28/2015
Additional Razadyne ER Information
Razadyne ER - User Reviews
Razadyne ER User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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