Wednesday, 20 February 2008

DUROGESIC fentanyl patch withdrawal does not affect Australians

DUROGESIC RESERVOIR PATCH

THE CASE

Janssen-Cilag the makers of Durogesic pain relief patches have recalled all batches of the 25 microgram/hr patches in the US. Other companies have also recalled batches of their fentanyl patches including Sandoz and Abrika.

The reason for the recall is that it is possible that some patches:

"may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel."

The defect is a possible cut in the drug reservoir that may allow the drug gel to escape, posing the danger of a narcotic overdose to anyone touching the gel. In addition the patient may receive a sub-therapeutic dose, leading to ineffective pain control.

Anyone who comes in contact with this gel should immediately wash the area with large amounts of cool water, do not use hot water or soap.

Fortunately the patches marketed in Australia do not have a drug reservoir, they are more sophisticated matrix style patch. Therefore Australian patches do not have this problem and will not have to be withdrawn.

Fentanyl is an opoid, and Durogesic patches are indicated for chronic pain requiring opioid analgesia. It is subsidised on the Australian Pharmaceutical Benefits Scheme (PBS) for "Chronic severe disabling pain not responding to non-narcotic analgesics".

As an aside it is worth noting here the storage and handling instructions for Durogesic. The Consumer Medical Information (CMI) for Durogesic says (in part):

"DO NOT expose the patch to direct heat from electric blankets, heat pads, heated water beds, heat lamps, intensive sunbathing, hot water bottles, saunas or hot spa baths while you are using DUROGESIC. Direct exposure to such heat may cause an increase in the amount of fentanyl absorbed by the skin."

"Disposal
The contents of DUROGESIC patches may be retrieved and abused by addicts. Fold used patches so that the adhesive side of the patch sticks to itself, wrap and dispose of carefully in the garbage."

MY VERDICT

At least we don't have to worry about this recall.

I wonder if this is one of those drug company power plays. They find fault in their own product, so withdraw it from the market, and by association cause the competitors products to be withdrawn also. But they alone have an alternative product and so are able to corner the market.

In this case the all the gel reservoir style patches will be withdrawn leaving only Janssen-Cilags matrix style patch.

This is not paranoia theory at work, there are well documented cases of this in the past.

2 comments:

Norma Leigh Lucid said...

Hi Diego,

I think you are being a bit paranoid.

You don't really expect us to believe that a company would deliberately publish bad things about one of their own products do you?

Diego Luego said...

There is no method of marketing that some drug company, somewhere, has not tried.

A bit over ten years ago, the non-sedating antihistamine Teldane (aka Seldane and Triludan) was about to go out of patent. Several generic drug manufacturers produced their own versions of terfenadine ready for sale and had even started marketing campaigns.

Suddenly the owners of Teldane, in a flurry of press releases, announced that Teldane was being withdrawn from the market because it produced an unacceptably high number of heart beat abnormalities. This was not actually news to a lot of people, but the press grabbed it, and ran away with it.

The generic drug manufacturers naturally had to follow suit, and thereby lost a lot of money.

Meanwhile the owners of Teldane said, not to worry we have a new non-sedating antihistamine Telfast (fexofenadine aka Allegra) that does not cause heart problems.

Nice marketing strategy eh! They get free publicity and remove competition in one go.