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Fatalities

In the placebo-controlled trial, 2 of 187 patients treated with placebo died as compared with 1 of 189 patients treated with pergolide mesylate. Of the 2,299 patients treated with pergolide mesylate in premarketing studies evaluated as of October 1988, 143 died while on the drug or shortly after discontinuing it. Because the patient population under evaluation was elderly, ill, and at high risk death, it seems unlikely that pergolide mesylate played any role in these deaths, but the possibility that pergolide shortens survival of patients cannot be excluded with absolute certainty.

In particular, a case-by-case review of the clinical course of the patients who died failed to disclose any unique set of signs, symptoms, or laboratory results that would suggest that treatment with pergolide caused their deaths. Sixty-eight percent (68%) of the patients who died were 65 years of age or older. No death (other than a suicide) occurred within the first month of treatment; most of the patients who died had been on pergolide for years. A relative frequency of the causes of death by organ system are:

* Pulmonary failure/Pneumonia, 35%;
* Cardiovascular, 30%;
* Cancer, 11%;
* Unknown, 8.4%;
* Infection, 3.5%;
* Extrapyramidal syndrome, 3.5%;
* Stroke, 2.1%;
* Dysphagia, 2.1%;
* Injury, 1 .4 %;
* Suicide, 1.4%;
* Dehydration, 0.7%;
* Glomerulonephritis, 0.7%.

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Side Effects and Precautions

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Fatalities

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