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The US Food and Drug Administration's Registry of Patients With Pergolide-Associated Valvular Heart Disease

      In the December 2002 issue of Mayo Clinic Proceedings, Pritchett and colleagues
      • Pritchett AM
      • Morrison JF
      • Edwards WD
      • Schaff HV
      • Connolly HM
      • Espinosa RE
      Valvular heart disease in patients taking pergolide.
      at the Mayo Clinic in Rochester, Minn, described 3 nonfatal cases of pergolide-related cardiac valvulopathy; 2 of the 3 cases, which resulted in single and multiple valve replacement, revealed carcinoid-like pathological changes on the explanted valve(s). At the end of 2002, the Food and Drug Administration had received 4 domestic and 11 foreign reports for a total of 15 cardiac valvulopathy cases (including those reported by Pritchett and colleagues). We summarize the remaining 12 unpublished reports of pergolide-associated cardiac valvulopathy (Table 1).
      Table 1Summary of 12 Cases of Pergolide-Associated Valvular Heart Disease, From the FDA Database
      Pergolide Valve
      Patient No./age (y)/sex Country of origin Dose (mg/d) Duration (mo) Event date Abnormality Involvement Confounding factor
      12–1/69/F Belgium 6 9 3/30/1999 Insufficiency
      Based on echocardiography. FDA = Food and Drug Administration; NR = not reported.
      Aortic, mitral, and tricuspid NR
      12–2/74/F Belgium 1.5 25 6/19/1998 Insufficiency
      Based on echocardiography. FDA = Food and Drug Administration; NR = not reported.
      Aortic, mitral, and tricuspid NR
      12–3/65/M Belgium 3 12 2/1999 Insufficiency
      Based on echocardiography. FDA = Food and Drug Administration; NR = not reported.
      Aortic, mitral, and tricuspid NR
      12–4/65/M Belgium 8 9 11/7/2002 Fibrosis
      Based on echocardiography. FDA = Food and Drug Administration; NR = not reported.
      NR NR
      12–5/73/F Belgium 7 24 11/7/2002 Fibrosis
      Based on echocardiography. FDA = Food and Drug Administration; NR = not reported.
      Aortic and tricuspid Bromocriptine, underlying hypertension
      12–6/75/M Finland 0.5 NR 6/17/2002 Insufficiency
      Based on echocardiography. FDA = Food and Drug Administration; NR = not reported.
      Tricuspid NR
      12–7/64/M Great Britain 1.5 36 NR Regurgitation Mitral Bromocriptine
      12–8/52/F Great Britain 4.5 48 NR Regurgitation Aortic and mitral Underlying cardiac ischemia
      12–9/77/M Great Britain 3 36 1998 Regurgitation Aortic, mitral, and tricuspid NR
      12–10/51/F Great Britain 1.5 48 1/1999 Regurgitation Mitral NR
      12–11/49/F Denmark 7 36 1999 Insufficiency Mitral NR
      12–12/NR/M United States Unknown NR NR Insufficiency Mitral NR
      * Based on echocardiography. FDA = Food and Drug Administration; NR = not reported.
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      REFERENCES

        • Pritchett AM
        • Morrison JF
        • Edwards WD
        • Schaff HV
        • Connolly HM
        • Espinosa RE
        Valvular heart disease in patients taking pergolide.
        Mayo Clin Proc. 2002; 77: 1280-1286
      1. Permax.
        in: Physicians' Desk Reference. 55th ed. Medical Economics Co Inc, Montvale, NJ2001: 668-670

      Linked Article

      • Additional Insights Into Pergolide-Associated Valvular Heart Disease
        Mayo Clinic ProceedingsVol. 78Issue 6
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          In the December 2002 issue of Mayo Clinic Proceedings, Pritchett and colleagues1 reported on newly documented valvular heart disease (VHD) in 3 adult patients, all of whom had been taking the ergot-derived dopamine receptor agonist pergolide mesylate (Permax, Eli Lilly and Company, Indianapolis, Ind2) long term. The authors theorized a possible cause-and-effect relationship based on several observations: First, all 3 patients had severe tricuspid valve regurgitation, typically combined with some degree of regurgitant left-sided VHD.
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