Posted by Carl D (208.4.16.94) on January 07, 2000 at 20:40:13:
The FDA is currently investigating a new case report involving the use of DHE 45 for the treatment of migraines and its association with heart valve disease. The link between long term use of ergotamine preparations like DHE 45 and heart valve lesions caused by endomyocardial fibrosis producing aortic and mitral valve regulation has been reported in the medical literature. Symptoms of heart valve disease include shortness of breath, fatigue, chest pain, elevated blood pressure or swelling of the ankles or abdomen. Contact your physician if any ofthe symptoms apply to you. We represent clients (on a contingency fee basis) who have been diagnosed with adverse effects.
MIGRAINE MEDICATIONS ARE LINKED TO HEART VALVE DISEASE
Portland, Oregon, August 18, 1999 - A group of attorneys have joined to conduct their own investigation into the possibility that women with undiagnosed heart problems could have had their hearts permanently and seriously injured by use of a migraine medication called DHE-45 (sold by Novartis). The generic name for the drug is dihydroergotamine mesylate. Another brand name used for it is Dihydergot.
DHE 45 is one of a family of drugs derived from fungal alkaloids, commonly known as ergotamines, which relieve pain by constricting blood vessels in the head. However, because these drugs work in part by affecting serotonin receptors, they put other parts of the cardiovascular system at risk, especially heart valves and the lining of the heart.
Although the scientific community that studies heart valve disease is aware of this connection, ( see, for example,the chapter by Mayo Clinic physician Margaret Redfield, on "Ergot Alkaloid Heart Disease" in Hurst's textbook "new Types of Cardiovascular disease", published in 1994,) these ergotamine preparations do not adequately warn prescribing doctors and their patients of the true risk of serious heart valve disease and the resulting consequences of treatment that can include open heart surgery and heart valve prostheses.
DHE-45 carries no warning about heart valve disease, and yet several serious heart valve cases have surfaced already in migraine sufferers who used DHE-45. The FDA has recently launched an investigation into the connection between DHE-45 and heart valve disease.
Portland based attorney Mike Williams says, "A new study published last week in the American Journal of Cardiology found that several of the serious heart valve cases in the Mayo Clinic landmark article about heart valve disease and fenphen shows that many of those women were migraine sufferers and probably took ergotamine derivatives." An editorial in the same issue of the journal says: "Clearly, there is an association between valvular abnormalities and drugs affecting serotonin receptors. . . . The study {of the supposed fenphen valve cases reported by the Mayo Clinic} in this issue of the American Journal of Cardiology provides data suggesting that some of the valve lesions seen in Connolly's report may have had other etiological factors. . . . Most notable among these was the use of other medications that enhance serotonin activity, specifically ergotamine, and selective serotonin reuptake inhibitors "
Williams indicates that if migraine sufferers take these medications and experience shortness of breath, unusual and unexplained fatigue, chest pain, palpitations or rapid heart beat, or dizziness, they should immediately call their physician.
For more information, those interested should call 1-800-842-1595 or visit www.wt.com.
FREQUENTLY ASKED QUESTIONS
1. What is ergotamine?
Answer: Ergotamine is a naturally occurring ergot alkaloid used in various preparations for the prophylaxis and treatment of migraine headaches. Ergot alkaloids halt a migraine attack by affecting blood vessels in the brain. Ergotamine shares similarities in chemical structure with serotonin, a naturally produced neurohormone. Serotonin is postulated to be the agent responsible for the characteristic endocardial and valvular disease seen in patients with carcinoid syndrome.
2. What drugs, specifically, would be included as ergotamine preparations?
Answer: There are many different ergotamine preparations. The most popular preparations include DHE 45, Migranal Nasal Spray, Ercaf, Gotamine, Wigraine, Ergomar, and Cafergot. Other less known preparations outside of the United States include Dergiflux, Dihydroergotamine-Sandoz, Dergotamine, Dihydergot, Erganton, Ergont, Ergovasan, Orstanorm, Seglor, Tamik, Tenuatina and others.
How are these drugs taken?
Answer: Ergotamine can be taken under the tongue. When combined with caffeine it is taken orally. It is also available as a suppository in combination with caffeine. Dihydroergota-mine is given intravenously or can be taken as a nasal spray.
How can ergotamine affect the heart?
Answer: Ergot alkaloid-associated heart disease refers to valvular lesions caused by endomyocardial fibrosis which extends onto the valve structures and distorts the anatomy of the valves, producing either stenosis, regurgitation or combined lesions. Endomyocardial fibrosis (without valvular disease), pericardial fibrosis, and myocardial ischemia are other forms of cardiac disease reported with ergot alkaloid use.
Why haven’t I heard about this before?
Answer: The association between heart valve disease and the use of ergotamines has only recently been reported in extreme cases of chronic, long-term use. These cases involved patients who took ergotamines daily over a long period of time – usually 12 years or longer. There is today, however, reason to believe that patients who take higher doses of ergotamine preparations on a daily basis may be affected in a shorter period of time, especially if these ergotamine preparations are taken in combination with other serotonin agonist drugs.
How do I know if my heart has been affected?
Answer: The easiest way to determine if a person has suffered heart valve damage is by a procedure called an echocardiogram. An echocardiogram is an ultrasound examination of the heart. This is basically the same kind of procedure as the ultrasound examination performed to check the growth of the fetus in a pregnant woman. The echocardiogram machine uses ultrasound waves and a computer to help make a video of the patient’s heart and heart valve movements during the routine beating of the heart. A small instrument (transducer) is placed on the chest wall along with some gel to help make the proper ultrasound connection. There is no pain associated with routine echocardiograms performed in this matter. The test can usually be performed within 30 to 45 minutes.
What are the symptoms of heart valve disease?
Answer: Primary symptoms of heart valve disease include: Shortness of breath, extreme fatigue, chest pain, pulmonary hypertension, swelling of the ankles and/or abdomen, dizziness and/or fainting, and heart palpitations. If you have any of these symptoms and/or are a chronic, long-term user of ergotamines, see your physician.
What should I say to my physician about this?
Answer: Tell your physician that you have recently learned there may be a link between heart valve damage and the chronic, long-term use of ergotamines. Ask for a physical examination and an echocardiogram.
How much will an echocardiogram cost, and how will it be paid?
Answer: The costs of performing and interpreting an echocardiogram varies considerably. It could be as little as $600 or as much as $1,200. You should contact your physician or medical care payor (insurance, HMO, Medicare, Medicaid, etc.) to determine how such a procedure will be covered in your individual case. Your attorneys are prohibited by law and code of ethics from paying or advancing the costs of this procedure for you.
I found this article while reaserching ERCAF, as someone suggested taking too much of it can poison you and cause some bad things to happen.
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