Mass recall of vitamins

The Advertiser - Friday, Tue, 29 April 2003  

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By PAUL STARICK in Canberra abnd JUDY SKATSSOON in Sydney


AUTHORITIES have ordered the biggest medical product recall in national history, warning consumers against taking herbal, vitamin or nutritional supplements.

Thousands of products from Australia's biggest producer, Pan Pharmaceuticals, are at risk because of a series of grave safety and quality breaches.

The federal medicines regulatory authority, the Therapeutic Goods Administration, yesterday suspended Sydney-based Pan's licence and ordered the immediate recall of 219 products.

Pan is Australia's largest contract manufacturer of herbal, vitamin and nutritional supplements.

Thousands more products may be involved because the TGA is still determining the full range of the affected product range and number of batches.

The authority will work with other companies which use Pan to make their own brand products to identify which other products should be recalled.

The medicines of most concern are those manufactured by Pan since May 1 last year.

The TGA is warning of potentially fatal allergic reactions or serious illness being caused if the recalled tablets are taken because they might contain untested herbs or contaminants.

Pan also makes some over-the-counter medicines including paracetamol, codeine, antihistamines and pseudoephedrine.

The TGA audited Pan after recalling its over-the-counter anti-travel sickness tablet, Travacalm, when faulty batches resulted in 19 people being hospitalised and 68 others having life-threatening reactions.

"Some people were very, very ill," Health Parliamentary Secretary Trish Worth said.

"I understand (they) tried to jump out of planes and off ships and things like that because of the hallucinatory effects that it had."

The subsequent audits found serious deficiencies in the company's manufacturing and quality control procedures, including systematic and deliberate manipulation of quality control data.

Ms Worth said the problems at Pan were endemic and "a very sorry tale indeed".

"There will be further investigations . . . it's possible that criminal charges will be laid," she said.

Newspaper advertisements have been placed today to inform consumers which products are at risk (see Pages 8 and 14).

TGA principal medical adviser Dr John McEwen said other products manufactured by Pan but sold under different brand names would be added to the list as they were discovered.

"Until people have had a chance to check newspaper advertisements, both tomorrow and later advertisements which may be at the end of the week or early next week, they should avoid taking their complementary or vitamin products unless there is some very special reason," he said.

He warned people to avoid taking all but the most reputable over-the-counter brands of painkillers and cold and flu substances.

But he stressed prescription medicines or drugs distributed under the Pharmaceutical Benefits Scheme were still safe to take.

He cited five instances where Pan released products containing raw materials that had not been tested for their safety and four cases where laboratory test results were manipulated to meet specifications.

There were four recent examples of test results of an export vitamin product being fabricated.

On several occasions beef cartilage had been substituted for shark cartilage in a shark cartilage preparation, Dr McEwen said.

"Our great worry is that a product may not be true to label," he said.

"It may have a herb in it that has not been appropriately tested and may have a contaminant in it that could cause a serious illness . . . or potentially fatal allergic reaction."

Australian Consumers Association health policy officer Martin Goddard said consumers would be "thinking twice" about buying alternative medicines in the future.

"I would encourage them to think twice about it and to think about whether they actually want these things," he said.

Pan will be able to regain its licence after six months if it can demonstrate appropriate safety standards.

Herron Pharmaceuticals said it did not source any of its products from Pan Pharmaceuticals.

Blackmores also said none of its products was manufactured by Pan or was affected by the recall.