May 9, 2007, 09:00:00AM. By Brenda Frohloff

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Aliso Viejo, CA: Permax distributor Valeant Pharmaceuticals International reported its first quarter results on May 1 of 2007, showing an increase in revenues, but making no mention of its voluntary agreement with the FDA to withdraw Permax from the market.

Permax is the Parkinson's disease drug now associated with the potential for serious heart valve damage. A significant number of patients taking the drug have developed abnormal thickening of valve tissue and consequent leakage in the heart valves.

Valeant's May 1 press release reported a 7% increase in revenues for the quarter ($213.4 million compared to $199.5 million in the first quarter of 2006). The 9-page report contains details of Valeant's finances, but does not mention the company pulling Permax from the shelves during the quarter. Nor does it disclose any accounting reserve for potential individual or class action lawsuits related to the drug.

So what do they mean by "recall"?
The Valeant website today continues to list Permax (generically known as pergolide) as one of its selected regional products for North America. The list makes no reference to the voluntary recall which the FDA announced it had agreed to prior to the end of March, 2007. The website includes a 4,600-word "prescribing information" document for Permax as a medication for Parkinson's disease sufferers, but even this document is silent on the recall, and apparently has not been updated since the market withdrawal agreement.

Nowhere on the website is there notice of the withdrawal agreement with the FDA, nor a clear warning about the status of Permax to patients, doctors, or the public.

A short history of Permax
Permax is a drug which was approved for treatment of Parkinson's disease in 1998, to be used to reduce loss of the brain chemical dopamine. It has also been used in the treatment of restless leg syndrome. An association between pergolide and valvular heart disease was first reported in 2002. In 2003 the FDA asked that the warnings related to the drug be amended to disclose the problem. In 2006, the FDA asked that the valvular heart disease warning be upgraded—it had to be shown right on the product label.

But it wasn't until this year that the drug was pulled from the market.

On March 29, 2007, the FDA issued an advisory that the companies manufacturing and distributing Permax had voluntarily agreed to withdraw the drug from the market due to the potential for heart valve damage. This advisory followed the results of two new studies in the New England Journal of Medicine(January, 2007) which showed that Parkinson's disease patients who were treated with the drug had a significantly increased chance of suffering serious damage to their heart valves.

The advisory did say that the FDA was working with the manufacturers of the drug to determine the possibility of continuing its availability to patients whose efforts to switch to a different treatment were unsuccessful.

Are the drug companies dispensing with accuracy?
Besides Valeant, two other companies, Par Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd. were mentioned in the March, 2007, FDA advisory as sellers and manufacturers of generic forms of Permax. The Par website continues to list Permax on its products list, showing that the product is available in three strengths. Teva's website, on the other hand, currently contains no listing or mention of Permax.

The contrast between the FDA Permax advisory and drug companies' silence about the withdrawal of the drug raises some questions. Who watches the drug companies for compliance after an announced drug withdrawal? What happens to old stock of the drug? What advice is given to drug salespeople calling on doctors? What about samples still in some doctor's office cupboard? Why don't the drug companies update their website information when a drug is found to be dangerous? Isn't it odd to carry on as if nothing has happened about Permax?

Stay tuned for some answers to these questions.

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