Migraines tend to
be genetic – meaning
that if one of your parents has suffered from migraines, you
have a 50% chance of getting one yourself. (If both parents
have suffered from migraines, your chances of getting one
increases
to 75%.)
While the causes of migraines are not completely understood,
it is believed that they are rooted in the central nervous
system and the brain stem. The
intense pain and other symptoms may be a result of interference in the brain’s
normal ability to perceive pain. Brain chemicals that are involved in our emotions
may also play a role, which could be why depression and/or anxiety can be warning
signs of an impending migraine attack.
Treatments like
MIGRANAL® (dihydroergotamine mesylate, USP) operate on pain receptor
sites in the brain, reducing the pain as well as nausea and sensitivity to
light/sound.
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.
Migranal Nasal Spray should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina. Migranal also should not be given to patients with uncontrolled hypertension, patients who have used 5-HT1 agonists, ergotamine-containing or ergot-type medications or methysergide within the last 24 hours, or patients with hemiplegic or basilar migraine. Migranal Nasal Spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function. Migranal Nasal Spray should not be administered to pregnant women or nursing mothers.
Serious cardiac events, including some that have been fatal, have occurred following use of DHE 45 but are extremely rare. During clinical studies and the foreign postmarketing experience with Migranal Nasal Spray, there have been no fatalities due to cardiac events.
The most commonly reported adverse events in clinical trials for Migranal Nasal Spray were rhinitis, altered sense of taste, application site reactions, dizziness, nausea and vomiting. Adverse events associated with discontinuation were rhinitis, dizziness, facial edema, cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paresthesia.
