Safety breaches force recall
By Judy Skatssoon
April 28, 2003
AUSTRALIANS have been warned against taking herbal, vitamin or nutritional supplements following the biggest recall of medical products in the country's history.
The national medicines watchdog, the Therapeutic Goods Administration (TGA), today suspended the licence of Pan Pharmaceuticals for six months and ordered the immediate withdrawal of 219 of its products following a series of grave safety and quality breaches.
Pan is Australia's largest contract manufacturer of herbal, vitamin and nutritional supplements.
It also makes some over-the-counter medicines including paracetamol, codeine, antihistamines and pseudoephedrine.
Pan represents 70 per cent of the Australian complementary medicine market and exports to dozens of countries.
The number of products recalled could blow out to several thousand in coming days.
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.
Dr McEwen said Pan lost its license following evidence of substitution of ingredients, manipulation of test results and substandard manufacturing processes.
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 also four recent examples of test results of an export vitamin product being fabricated.
Dr McEwen also said on several occasions beef cartilage had been substituted for shark cartilage in a shark cartilage preparation.
"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."
Pan first came to the attention of the TGA over its travel sickness tablet Travacalm, which was recalled in January, Parliamentary health secretary Trish Worth said.
Faulty batches of the tablets resulted in at least 87 adverse reactions and 19 hospitalisations.
In some cases people attempted to jump out of planes or off boats because they were experiencing severe hallucinations, Ms Worth said.
The Travacalm incident led to further investigations which found the problems highlighted with the Travacalm tablets were "endemic" at Pan, Ms Worth said.
"There were substitutions, there was manipulation of data and it was a very sorry tale indeed."
"There will be further investigations ... and it's possible that criminal charges will be laid."
Regulatory authorities in other countries were being informed of the development, Dr McEwen said.
He said the TGA would publish a list of recalled products in newspaper advertisements and on its websites over the next few days.
Until then, consumers should avoid taking herbal and vitamin preparations, Dr McEwen said.
"Until people have had a chance to check the 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.
People should also avoid taking all but the most reputable over-the-counter brands of painkillers and cold and flu preparations, Dr McEwen said.
However, he stressed consumers should not stop taking prescription medicines or PBS pharmaceuticals.
Pan would be able to regain its licence after six months if it could demonstrate it had cleaned up its act, he said.
Shares in Pan Pharmaceuticals plummeted 29 cents to $1.20, representing a fall of 19.5 per cent, ahead of a trading halt following the TGA announcement.
Comment was being sought from Pan.
Full list of recalled products
AAP
http://news.com.au/common/story_page/0,4057,6349938%5E2,00.html
By Judy Skatssoon
April 28, 2003
AUSTRALIANS have been warned against taking herbal, vitamin or nutritional supplements following the biggest recall of medical products in the country's history.
The national medicines watchdog, the Therapeutic Goods Administration (TGA), today suspended the licence of Pan Pharmaceuticals for six months and ordered the immediate withdrawal of 219 of its products following a series of grave safety and quality breaches.
Pan is Australia's largest contract manufacturer of herbal, vitamin and nutritional supplements.
It also makes some over-the-counter medicines including paracetamol, codeine, antihistamines and pseudoephedrine.
Pan represents 70 per cent of the Australian complementary medicine market and exports to dozens of countries.
The number of products recalled could blow out to several thousand in coming days.
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.
Dr McEwen said Pan lost its license following evidence of substitution of ingredients, manipulation of test results and substandard manufacturing processes.
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 also four recent examples of test results of an export vitamin product being fabricated.
Dr McEwen also said on several occasions beef cartilage had been substituted for shark cartilage in a shark cartilage preparation.
"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."
Pan first came to the attention of the TGA over its travel sickness tablet Travacalm, which was recalled in January, Parliamentary health secretary Trish Worth said.
Faulty batches of the tablets resulted in at least 87 adverse reactions and 19 hospitalisations.
In some cases people attempted to jump out of planes or off boats because they were experiencing severe hallucinations, Ms Worth said.
The Travacalm incident led to further investigations which found the problems highlighted with the Travacalm tablets were "endemic" at Pan, Ms Worth said.
"There were substitutions, there was manipulation of data and it was a very sorry tale indeed."
"There will be further investigations ... and it's possible that criminal charges will be laid."
Regulatory authorities in other countries were being informed of the development, Dr McEwen said.
He said the TGA would publish a list of recalled products in newspaper advertisements and on its websites over the next few days.
Until then, consumers should avoid taking herbal and vitamin preparations, Dr McEwen said.
"Until people have had a chance to check the 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.
People should also avoid taking all but the most reputable over-the-counter brands of painkillers and cold and flu preparations, Dr McEwen said.
However, he stressed consumers should not stop taking prescription medicines or PBS pharmaceuticals.
Pan would be able to regain its licence after six months if it could demonstrate it had cleaned up its act, he said.
Shares in Pan Pharmaceuticals plummeted 29 cents to $1.20, representing a fall of 19.5 per cent, ahead of a trading halt following the TGA announcement.
Comment was being sought from Pan.
Full list of recalled products
AAP
http://news.com.au/common/story_page/0,4057,6349938%5E2,00.html