Permax Information

   There is urgent news for Parkinson’s patients who took
pergolide therapy, or Permax. Researchers from the Mayo Clinic
reported that three patients who used Permax developed severe
heart valve disease, much like the deterioration and regurgitation
resulting from the diet drug Fen Phen. Two of these Permax
patients needed heart valve replacement and the third suffered
other serious damage to the valves. The US Food and Drug
Administration (FDA) and Mayo Clinic have ordered further
investigation into the side effects of Permax.

    Permax, or pergolide mesylate, is a drug developed by the
pharmaceutical company Eli Lilly to treat Parkinson’s disease.
According to Kindra Strupp, spokeswoman for Eli Lilly, more than
500,000 people have taken Permax since the product was
approved for treatment of Parkinson's disease patients about 13
years ago. Strupp noted that the company is aware of the valve
disorder and that they have been in contact with the FDA. Amarin
Pharmaceuticals Inc. markets Permax in the US, and is also aware
of the valve disease.

    Dr. Raul Espinosa, a cardiologist at the Mayo Clinic and one of
the authors of the report, says that further investigation into other
heart valve surgeries is underway to determine if the condition
stemming from pergolide is under-recognized by doctors. This
investgation came about after the initial report indicating three
cases in which women in their 60's or 70's who were taking
Permax developed severe, unexplained valvular heart disease.
None of the patients--a 72-year-old, 74-year-old and 61-year-old--
had used other drugs associated with heart valve problems.
The patients had symptoms such as fluid retention in the legs,
breathing difficulties and heart murmurs that can be indicative of
heart valve problems. The heart valves keep blood from flowing
backwards in the organ, and are essential to the normal flow of
blood. Two of the patients underwent surgery to replace the
defective valves. Once the valves were removed, and examined,
large surface lesions were identified on the valves.

    The drug's makers say that Permax has had a safe record since
coming on the market, but that they would consider adding the
information when they update the labeling on the Permax package.
Dr. Abraham Lieberman, the medical director of the National
Parkinson Foundation in Miami, was one of the doctors who
studied pergolide in the 1980's, when it was being developed.
"There is evidence of pulmonary fibrosis that is associated with
pergolide," he says, "but there's a 14-year history of people taking
Permax, and why hasn't this showed up sooner?"
Pergolide shares characteristics with a number of other drugs that
have been associated with valvular heart disease. These drugs,
including Fen-Phen, which is taken for weight loss, are all
associated with a heightened stimulation of serotonin receptors
which cause the valve damage.

    Parkinson's disease is a progressive neurological disorder
resulting from the degeneration of neurons in a region of the brain
that controls movement. The degeneration creates a shortage of
the brain-signaling chemical known as dopamine, causing the
involuntary movements that characterize the disease. In the United
States, at least 1.5 million people are believed to be affected by
Parkinson's disease according to the National Parkinson
Foundation Inc. (NPF), and about 50,000 new cases are reported
annually, according to the National Institute of Neurological
Disorders and Stroke.