[Sumatriptan Side Effects]
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Zogenix, Inc. was granted approval of the Sumavel™ DosePro™ (sumatriptan
injection) needle-free delivery system which enables subcutaneous delivery of
sumatriptan without a needle for the treatment of acute migraine. The FDA
approval of Sumavel DosePro is based on extensive efficacy and safety data
from original filings for needle-based sumatriptan injection (IMITREX®), in
addition to clinical studies conducted by Zogenix on bioequivalence, usability
and safety specific to the Sumavel DosePro combination drug/needle-free
delivery system. 
The most common adverse side effects observed in controlled clinical trials
with sumatriptan injection were injection site reactions, atypical sensations
(such as feelings of tingling, warm/hot sensations), dizziness and flushing.
Most side effects lasted for only a short time. In clinical trials comparing the
safety and tolerability of Sumavel DosePro to sumatriptan injection, most
injection site reactions resolved spontaneously, with no apparent difference
between Sumavel DosePro and sumatriptan needle injection.
Sumavel DosePro should only be used where a clear diagnosis of migraine or
cluster headache has been established.
Sumavel DosePro is contraindicated in patients with ischemic heart disease or
those with symptoms consistent with ischemic heart disease. Sumavel
DosePro should not be administered to patients with cerebrovascular
syndromes, peripheral vascular disease or in patients with uncontrolled
hypertension. Very rarely, serious cardiac adverse side effects have been
reported when taking sumatriptan, including patients with no findings of
cardiovascular disease. Considering the extent of use of sumatriptan in
patients with migraine, the incidence of these side effects is extremely low.
Sumavel DosePro should not be used within 24 hours of other
ergotamine-containing or ergot-type medications or other 5-HT1( )agonists
and is not generally recommended for use with selective serotonin reuptake
inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors SNRIs or MAO
inhibitors. Sumavel DosePro should be used during pregnancy only if the
potential benefit justifies the potential risk or side effects to the fetus.
 Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for
Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro
Needle-Free Delivery System PRNewswire July 16 2009  www.zogenix.com,
July 16, 2009