"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
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 clinical practice.
In clinical studies, 496 patients were exposed to Amyvid. Amyvid caused no serious adverse reactions in the studies and the reported adverse reactions were predominantly mild to moderate in severity. The adverse reactions reported in more than one subject within the studies are shown in Table 2.
Table 2: Adverse Reactions
Reported in Clinical Trials (N=496 patients)
|Adverse Reactions||N (Percent of patients)|
|Musculoskeletal pain||4 (0.8%)|
|Back pain||2 (0.4%)|
|Blood pressure increased||2 (0.4%)|
|Feeling cold||2 (0.4%)|
|Neck pain||2 (0.4%)|
Read the Amyvid (florbetapir f 18 injection) Side Effects Center for a complete guide to possible side effects
Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Amyvid image results.
Within a clinical study of patients with a range of cognitive impairment, some patients with probable AD were receiving the following medications: donepezil, galantamine, memantine. Mean cortical Standardized Uptake Value (SUV) ratios did not differ between the patients taking or not taking these concomitant medications. In in vitro tests, none of the drugs tested, including the acetylcholinesterase inhibitors donepezil, galantamine, and tacrine, altered florbetapir F 18 binding to its target.
Last reviewed on RxList: 4/16/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Amyvid Information
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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