Safety concerns lead to withdrawal of pergolide in the US
Pergolide, a Parkinson's disease therapy, is being withdrawn from the US market because of its potential to cause heart valve damage, the US Food and Drug Administration has announced. No similar action is being taken in the UK or Europe, although measures introduced in 2004–05 to reduce the risk associated with the drug continue to be monitored.
At the end of last week, the FDA announced that companies that manufacture
and distribute pergolide have agreed voluntarily to withdraw the drug.
US patients being treated with pergolide are to be reviewed and, if continued
treatment with a dopamine agonist is considered necessary, another dopamine
agonist will be substituted.
A spokesman for Lilly, which markets pergolide as Celance in the UK,
told The Journal that the company was not taking action in the UK or
Europe.
He explained that the drug is indicated for first-line use in the US,
whereas its use is restricted to second-line in the UK. He added that
pergolide is not widely prescribed in the UK.
The Medicines and Healthcare products Regulatory Agency issued
a statement following the US announcement. It said: “In late 2004/early 2005
the use of pergolide was restricted to use under specialist supervision
in patients who had failed therapy with other (non-ergot) medicines for
Parkinson’s disease. In addition, monitoring requirements for regular
echocardiograms were added in the EU to minimise risk to patients.”
There will be further review of this issue at a European level later
this month to consider what further action is required in the EU to minimise
risk, the MHRA said.
The agency also pointed out that research has indicated a similar frequency
of heart valve damage with cabergoline (Cabaser) as with pergolide. “As
a result, the same restrictions are being applied to the use of cabergoline
for Parkinson’s disease as for pergolide.”
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