Fondaparinux adverse reactions: Difference between revisions
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{{CMG}}; {{AE}} {{AZ}} | {{CMG}}; {{AE}} {{AZ}} | ||
==Adverse Reactions== | |||
The most serious adverse reactions reported with ARIXTRA are [see Warnings and Precautions (5)]: | |||
:*[[Bleeding]] complications | |||
:*[[Thrombocytopenia]] | |||
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 adverse reaction information below is based on data from 8,877 patients exposed to ARIXTRA in controlled trials of hip fracture, hip replacement, major knee, or abdominal surgeries, and DVT and PE treatment. | |||
These trials consisted of the following: | |||
:*2 peri-operative dose-response trials (n = 989) | |||
:*4 active-controlled peri-operative VTE prophylaxis trials with enoxaparin sodium (n = 3,616), an extended VTE prophylaxis trial (n = 327), and an active-controlled trial with dalteparin sodium (n = 1,425) | |||
:*a dose-response trial (n = 111) and an active-controlled trial with enoxaparin sodium in DVT treatment (n = 1,091) | |||
:*an active-controlled trial with heparin in PE treatment (n = 1,092)<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=05bb2dd4-5fb5-4ec9-29a8-d200e62d1a8f | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Revision as of 23:30, 5 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Adverse Reactions
The most serious adverse reactions reported with ARIXTRA are [see Warnings and Precautions (5)]:
- Bleeding complications
- Thrombocytopenia
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 adverse reaction information below is based on data from 8,877 patients exposed to ARIXTRA in controlled trials of hip fracture, hip replacement, major knee, or abdominal surgeries, and DVT and PE treatment.
These trials consisted of the following:
- 2 peri-operative dose-response trials (n = 989)
- 4 active-controlled peri-operative VTE prophylaxis trials with enoxaparin sodium (n = 3,616), an extended VTE prophylaxis trial (n = 327), and an active-controlled trial with dalteparin sodium (n = 1,425)
- a dose-response trial (n = 111) and an active-controlled trial with enoxaparin sodium in DVT treatment (n = 1,091)
- an active-controlled trial with heparin in PE treatment (n = 1,092)[1]
References
Adapted from the FDA Package Insert.