Top Glaxo drugs seized in US swoop

[Anonymous]

Top Glaxo drugs seized in US swoop

Heather Tomlinson
Saturday March 5, 2005
The Guardian

The US authorities yesterday seized stocks of two top-selling GlaxoSmithKline drugs because they were poorly made and posed a health risk to patients.
The seizures are a major blow as they will lead to shortages of drugs in America, the most lucrative market for the pharmaceuticals industry, and potentially around the world. The British drug regulator is investigating to find out whether any of the faulty products have made their way here.

The US regulator, the food and drug administration, found that tablets of the antidepressant Paxil, known as Seroxat in Britain, could split and might not contain any drug at all. The pill has caused controversy over concerns that it could make some patients suicidal, although it was ruled safe after an inquiry.

The FDA also found that tablets of the diabetes drug Avandamet did not contain an accurate dose. The dosage is crucial to the effectiveness of the drug. "The FDA and the department of justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said an FDA official, John Taylor.

The regulator took action after Glaxo, Britain's largest drugs firm, received consistent warnings about the poor quality of manufacturing at its plants in Puerto Rico.

Glaxo initially received a warning letter in 2002 when the regulator found bacterial contamination at the plant and problems with manufacturing processes.

The firm said these problems were resolved. However, the FDA inspected the plant in 2003 and again last November, and it said yesterday that "violations had not been adequately corrected". The regulator said that Glaxo voluntarily withdrew some tablets, but not all of the affected product, which prompted the seizure by officials.

The British regulator, the Medicines and Healthcare products Regulatory Agency, said that the Puerto Rico plant does not sell pills directly to this country. However, in Europe drugs can be exported and imported between nations, and inspectors are in discussions with Glaxo to establish whether faulty products might have entered the country.

European authorities said they are planning to conduct their own inspection of the plant and that there could be "serious compliance issues" related to the US regulator's claims.

The FDA said the faulty pills could pose risks but added that there is no "significant health hazard". Patients should carry on taking them and go to their doctor to ask for alternatives.

Avandamet is one of the firm's top selling products and the action is likely to disrupt supplies around the world. Paxil CR sales in America were worth nearly £400m last year.

Glaxo said it did not think the manufacturing issues posed a health risk. "The company is working with the FDA to resolve these issues as quickly as possible," the firm said in a statement.

It is not clear how long it will take to resolve the problem. Glaxo said that the plant has not been closed down, and it is continuing to make other products there.

The firm's shares fell 2% yesterday to close at £12.89p. The news had a knock-on effect on British drug firm SkyePharma, which receives royalties from the sales of Paxil CR, and its shares fell 14% to 52p.

Glaxo also issued its annual report yesterday which revealed directors' pay.

Jean-Pierre Garnier, the chief executive whose pay provoked an investor rebellion two years ago, took home $4.6m (£2.4m) in salary and bonuses, slightly lower than last year.

He received $1.5m in cash and made gains on share options worth $3m.

He also received share-based awards, and had an extra $1.5m added to his pension pot.

[Anonymous]

OMG!! http://www.cafepharma.com/ubbthreads/images//graemlins/frown.gif

[Anonymous]

Ha Ha Ha Ha Ha! This couldn't have happened to a better company. To all the Avandia and Avandamet reps out there trying to muddy the waters and badmouth Takeda's Head to Head study rather than excepting that your drug is secondbest in its class.....What's up NOW???? Enjoy the coming weeks, I know I will, having all your doctors switch patients from Avandamet to Actos and Metformin.
Sincerely Y http://www.cafepharma.com/ubbthreads/images//graemlins/grin.gifours, Tubby Triglyceride

[Anonymous]

[ QUOTE ]
Ha Ha Ha Ha Ha! This couldn't have happened to a better company. To all the Avandia and Avandamet reps out there trying to muddy the waters and badmouth Takeda's Head to Head study rather than excepting that your drug is secondbest in its class.....What's up NOW???? Enjoy the coming weeks, I know I will, having all your doctors switch patients from Avandamet to Actos and Metformin.
Sincerely Y http://www.cafepharma.com/ubbthreads/images//graemlins/grin.gifours, Tubby Triglyceride

[/ QUOTE ]

Good luck Avandia/Avandamet is dominating the market. You are losing big time. Wasn't there another study in that very same clinical that contradicted the results of the one that you promote. Also why were 4500 patients enrolled in the study and only 500 used for the results?? Ask any doc and they will see that they do not see this drastic or any difference at all when it comes to either TZD....

The avandamet was already replaced weeks ago with
"newer" product. So the press release was too late for the party you are trying to throw..

[Anonymous]

Too bad the government can't seize GSK's bad senior management! I could name a few worthless executives that should be nabbed: Garnier, Stout, Viehbacher ....

[Anonymous]

Wow, you really are drinking the GSK corporate kool aid aren't you? The study screened 4500 patients and only 759 went through the study because they were trying to find 2 EXACTLY similar groups (trying to avoid the exact bullshit your compnay is having you pull right now). They screen 4500 patients looking for exact and identical patient populations for the parallel groups, so that you wouldn't bitch about baseline this, and endpoint that. This is study number 16 that shows a clear and true advantage for Actos. Keep getting the Ra Ra from your manager, but do some research yourself....the truth is out there. And not one study puts your product on top. Sleep tight.

[thickbuck]

NO SURPRISES HERE. EVEN BACK TO THE EARLY AVANDIA DAYS, THEY OUTSOLD GSK WITH HALF THE SIZE SALES FORCE INCLUDING LILLY. JUST PURE SALES SKILLS. PLAIN AND SIMPLE.

[PlanktonIsGod]

[ QUOTE ]
Wow, you really are drinking the GSK corporate kool aid aren't you? The study screened 4500 patients and only 759 went through the study because they were trying to find 2 EXACTLY similar groups (trying to avoid the exact bullshit your compnay is having you pull right now). They screen 4500 patients looking for exact and identical patient populations for the parallel groups, so that you wouldn't bitch about baseline this, and endpoint that. This is study number 16 that shows a clear and true advantage for Actos. Keep getting the Ra Ra from your manager, but do some research yourself....the truth is out there. And not one study puts your product on top. Sleep tight.

[/ QUOTE ]

Oh I do sleep tight. All these "studies," no product to sell against, and you still can't gain any real market share in my territory. You're a joke of a sales force.

[thecheat]

how exactly do you revive a post that's a year old?

[toofunny]

no kidding. let sleeping dogs lie.

speaking of dogs - any chance this company will try to revive paxil cr? as a priority rep, i sure hope not. oh wait, this is the company that puts you on a brand for 1 or 2 quarters then yanks you off to go to another product.

way to build consistency there david.

[janitor]

[ QUOTE ]
Top Glaxo drugs seized in US swoop

Heather Tomlinson
Saturday March 5, 2005
The Guardian

The US authorities yesterday seized stocks of two top-selling GlaxoSmithKline drugs because they were poorly made and posed a health risk to patients.
The seizures are a major blow as they will lead to shortages of drugs in America, the most lucrative market for the pharmaceuticals industry, and potentially around the world. The British drug regulator is investigating to find out whether any of the faulty products have made their way here.

The US regulator, the food and drug administration, found that tablets of the antidepressant Paxil, known as Seroxat in Britain, could split and might not contain any drug at all. The pill has caused controversy over concerns that it could make some patients suicidal, although it was ruled safe after an inquiry.

The FDA also found that tablets of the diabetes drug Avandamet did not contain an accurate dose. The dosage is crucial to the effectiveness of the drug. "The FDA and the department of justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said an FDA official, John Taylor.

The regulator took action after Glaxo, Britain's largest drugs firm, received consistent warnings about the poor quality of manufacturing at its plants in Puerto Rico.

Glaxo initially received a warning letter in 2002 when the regulator found bacterial contamination at the plant and problems with manufacturing processes.

The firm said these problems were resolved. However, the FDA inspected the plant in 2003 and again last November, and it said yesterday that "violations had not been adequately corrected". The regulator said that Glaxo voluntarily withdrew some tablets, but not all of the affected product, which prompted the seizure by officials.

The British regulator, the Medicines and Healthcare products Regulatory Agency, said that the Puerto Rico plant does not sell pills directly to this country. However, in Europe drugs can be exported and imported between nations, and inspectors are in discussions with Glaxo to establish whether faulty products might have entered the country.

European authorities said they are planning to conduct their own inspection of the plant and that there could be "serious compliance issues" related to the US regulator's claims.

The FDA said the faulty pills could pose risks but added that there is no "significant health hazard". Patients should carry on taking them and go to their doctor to ask for alternatives.

Avandamet is one of the firm's top selling products and the action is likely to disrupt supplies around the world. Paxil CR sales in America were worth nearly £400m last year.

Glaxo said it did not think the manufacturing issues posed a health risk. "The company is working with the FDA to resolve these issues as quickly as possible," the firm said in a statement.

It is not clear how long it will take to resolve the problem. Glaxo said that the plant has not been closed down, and it is continuing to make other products there.

The firm's shares fell 2% yesterday to close at £12.89p. The news had a knock-on effect on British drug firm SkyePharma, which receives royalties from the sales of Paxil CR, and its shares fell 14% to 52p.

Glaxo also issued its annual report yesterday which revealed directors' pay.

Jean-Pierre Garnier, the chief executive whose pay provoked an investor rebellion two years ago, took home $4.6m (£2.4m) in salary and bonuses, slightly lower than last year.

He received $1.5m in cash and made gains on share options worth $3m.

He also received share-based awards, and had an extra $1.5m added to his pension pot. [/qu

Who is pulling the wool over who's eyes???? That is the question.

[thecheat]

[ QUOTE ]
[ QUOTE ]
Top Glaxo drugs seized in US swoop

Heather Tomlinson
Saturday March 5, 2005
The Guardian

The US authorities yesterday seized stocks of two top-selling GlaxoSmithKline drugs because they were poorly made and posed a health risk to patients.
The seizures are a major blow as they will lead to shortages of drugs in America, the most lucrative market for the pharmaceuticals industry, and potentially around the world. The British drug regulator is investigating to find out whether any of the faulty products have made their way here.

The US regulator, the food and drug administration, found that tablets of the antidepressant Paxil, known as Seroxat in Britain, could split and might not contain any drug at all. The pill has caused controversy over concerns that it could make some patients suicidal, although it was ruled safe after an inquiry.

The FDA also found that tablets of the diabetes drug Avandamet did not contain an accurate dose. The dosage is crucial to the effectiveness of the drug. "The FDA and the department of justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said an FDA official, John Taylor.

The regulator took action after Glaxo, Britain's largest drugs firm, received consistent warnings about the poor quality of manufacturing at its plants in Puerto Rico.

Glaxo initially received a warning letter in 2002 when the regulator found bacterial contamination at the plant and problems with manufacturing processes.

The firm said these problems were resolved. However, the FDA inspected the plant in 2003 and again last November, and it said yesterday that "violations had not been adequately corrected". The regulator said that Glaxo voluntarily withdrew some tablets, but not all of the affected product, which prompted the seizure by officials.

The British regulator, the Medicines and Healthcare products Regulatory Agency, said that the Puerto Rico plant does not sell pills directly to this country. However, in Europe drugs can be exported and imported between nations, and inspectors are in discussions with Glaxo to establish whether faulty products might have entered the country.

European authorities said they are planning to conduct their own inspection of the plant and that there could be "serious compliance issues" related to the US regulator's claims.

The FDA said the faulty pills could pose risks but added that there is no "significant health hazard". Patients should carry on taking them and go to their doctor to ask for alternatives.

Avandamet is one of the firm's top selling products and the action is likely to disrupt supplies around the world. Paxil CR sales in America were worth nearly £400m last year.

Glaxo said it did not think the manufacturing issues posed a health risk. "The company is working with the FDA to resolve these issues as quickly as possible," the firm said in a statement.

It is not clear how long it will take to resolve the problem. Glaxo said that the plant has not been closed down, and it is continuing to make other products there.

The firm's shares fell 2% yesterday to close at £12.89p. The news had a knock-on effect on British drug firm SkyePharma, which receives royalties from the sales of Paxil CR, and its shares fell 14% to 52p.

Glaxo also issued its annual report yesterday which revealed directors' pay.

Jean-Pierre Garnier, the chief executive whose pay provoked an investor rebellion two years ago, took home $4.6m (£2.4m) in salary and bonuses, slightly lower than last year.

He received $1.5m in cash and made gains on share options worth $3m.

He also received share-based awards, and had an extra $1.5m added to his pension pot. [/qu

Who is pulling the wool over who's eyes???? That is the question.

[/ QUOTE ]


Again, this is old news. This was published A YEAR AGO.

[Anonymous]

paxil cr sucks ass anyway so the reps!

[Anonymous]

Even if it was from last year, obviously nothing has changed in a year. Just more problems.