Australia's largest recall of medicines in the nations history

AUSTRALIANS were today warned to avoid taking all herbal and vitamin preparations following the largest recall of medicines in the nation's history.



Federal parliamentary secretary for health Trish Worth said several thousand products may potentially be withdrawn following the six-month suspension of Pan Pharmaceutical's licence.

Pan Pharmaceuticals, Australia's largest contract manufacturer of complementary pharmaceuticals, has had its licence suspended following a series of safety and quality breaches.

The Therapeutic Goods Administration (TGA) also ordered the urgent recall of 219 products manufactured and supplied in Australia by the company.

In a statement, the TGA said the breaches included substitution of ingredients, manipulation of test results and substandard manufacturing processes.

The TGA's principal medical adviser Dr John McEwen said "people ... should avoid taking complementary or vitamin products" until more information became available over the next few days.

Pan Pharmaceuticals represents 70 per cent of the Australian complementary pharmaceutical market and is the largest manufacturer of medicines such as herbal, vitamin, mineral and nutritional supplements.

It also manufactures some over-the-counter medicines including pain relievers and cold and flu preparations.

In January, an anti-travel sickness tablet Travacalm made by Pan Pharmaceuticals for another company was recalled.

Forty batches of the tablets were responsible for 19 people being hospitalised and 68 others experienced potentially life-threatening adverse reactions.

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Young girl sues over travel pill
April 29 2003

A Melbourne law firm today launched legal action against Pan Pharmaceuticals after a 10-year-old girl suffered a severe reaction to travel sickness medication.

Maurice Blackburn Cashman lawyer Eugene Arocca said the girl was delirious, had hallucinations, agitation, dilated pupils and was atoxic after taking the medication, Travacalm, in January.

Mr Arocca said the firm had already been in contact with Pan and its insurance company over the claim.

"We were approached by the father of a 10-year-old girl who has suffered from travel sickness since the age of two," Mr Arocca said in a statement.

"In January this year she took a single dose of Travacalm, with devastating consequences."

The drug was subsequently subject to a recall after analysis by the Therapeutic Goods Administration (TGA) showed some tablets contained ingredient doses much higher than the labels indicated.

After taking the Travacalm tablet, the Victorian girl was taken to the Royal Children's Hospital in Melbourne where she was told she had suffered a suspected overdose of the drug.

The diagnosis was Anticholinergic (Anticholinergic) Syndrome caused by Travacalm, the law firm said in its statement.

The Victorian girl now had a probable life-long reaction to the drug and must carry an "Adverse Drug Reaction Alert Card" when visiting any medical practitioner, it said.

Mr Arocca said legal action would be taken under the Trade Practices Act as the product was not of "merchantable quality".

"Other consumers who have suffered a reaction to the defective drugs could have actions against the company," he said.

He said shareholders and other companies affected by the supply of defective drugs could launch legal action.

Maurice Blackburn Cashman has scheduled a media conference on the issue at noon (AEST).

From: http://www.theage.com.au/articles/2003/04/29/1051381929360.html

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