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Lisa
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Lid sinds: 02/09/2008 - 13:05
Waarschuwing over Avandia (diabetes medicijn)

Wetenschappers waarschuwen voor het gebruik van Avandia (Rosiglitazon).
Het is in Nederland ook verkrijgbaar.

http://www.guardian.co.uk/society/2009/aug/19/diabetes-rosiglitazone-ava...

Stop prescribing killer diabetes drug, scientists warn

Rosiglitazone, brand name Avandia, has higher rates of heart failure and death than similar alternative

Scientists say doctors should stop prescribing a commonly used diabetes drug, after studies show that it is linked to higher rates of heart failure and death than a similar alternative.

David Juurlink, a Toronto-based pharmacologist and lead author of a paper published online today by the British Medical Journal, says that doctors should no longer prescribe rosiglitazone, which is sold under the brand name Avandia.

His study looked at nearly 40,000 patients aged 66 or older who had been given either rosiglitazone or a similar drug, pioglitazone, by their doctors between April 2002 and March 2008 for type 2 (obesity-related) diabetes. They found that those on pioglitazone had a significantly lower risk of heart failure or death than those on rosiglitazone.

For every 93 patients treated with rosiglitazone rather than pioglitazone, one extra heart failure or death would occur every year, they say.

There has been controversy for some time over rosiglitazone's effects on the heart. Some scientists have argued over the interpretation of previous studies. But Dr Juurlink, division head of clinical pharmacology and toxicology at the Sunnybrook Health Sciences Centre in Toronto, believes it is time for doctors to stop using the drug.

"As a clinician, I cannot envision an instance in which I would recommend rosiglitazone over pioglitazone," he said.

"My logic for recommending that rosiglitazone no longer be used is several-fold: there is an increasing body of evidence that rosiglitazone is associated with more harm than pioglitazone, there is biological plausibility to support this (outlined in our paper – rosiglitazone is a more potent stimulus for salt and water retention in the kidney) and not a single study, to my knowledge, has suggested that pioglitazone might be less safe than rosiglitazone.

"Importantly, rosiglitazone has not a single advantage – not even a theoretical one – over pioglitazone."

The risks and benefits of the drug have been evaluated by the European Medicines Agency, responsible for licensing across Europe, which said in October 2007 that the benefits of both drugs outweighed their risks. But it warned that rosiglitazone should only be used after a careful assessment of any patient with heart disease.

An editorial published online with the paper suggests that it is still too soon to dismiss rosiglitazone. Two experts, Corinne de Vries, professor of pharmacoepidemiology at the University of Bath, and David Russell-Jones, professor of diabetes and endocrinology at the University of Surrey, say that more studies should be done. They urge patients to consult their GP and not discontinue their medicine.

Lisa ( )
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Nieuw bewijs dat Avandia een gevaarlijk medicijn is

Dat Avandia is nog steeds op de markt, ook in Nederland, zag ik :huh:

Two new studies point to risks for people taking the diabetes drug Avandia

Door Rob Stein
Washington Post Staff Writer
Tuesday, June 29, 2010

Two teams of researchers have produced powerful new evidence that the diabetes drug Avandia increases the risk of heart problems and strokes, renewing questions about the safety of the medication.

One analysis, involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack. The second, a federal analysis of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure and death.

The new research, released Monday, should prompt the Food and Drug Administration to remove the drug from the market, according to the researchers who led the analyses and several drug-safety advocates.

"There's no reason to keep this drug on the market," said Steven E. Nissen, a Cleveland Clinic cardiologist who conducted one of the analyses and has long criticized the drug. "This is a harmful drug."

[...]

In one of the new analyses, Nissen and a colleague pooled data from 56 studies involving 35,531 people, including 19,509 who took Avandia. In a paper released online by the Archives of Internal Medicine, the researchers concluded that the drug increased the risk for heart attacks from 28 percent to 39 percent. The pair calculated that the drug would cause one heart attack among every 37 to 52 people who used it for five years.

In the second analysis, Graham and his colleagues analyzed Medicare records for 227,571 people who took either Avandia or another diabetes drug called Actos from 2006 to 2009.

They found that those who took Avandia were 27 percent more likely to have a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die during the study period than were those who took Actos.

Based on the findings, released online by the Journal of the American Medical Association, the researchers estimated that there would be one heart attack, death, stroke or heart failure in every 60 people who took the drug for one year.

Van elke 60 mensen die Avandia 1 jaar slikken overkomt 1 van hen een hartaanval, een beroerte, hartfalen of sterfte.

meer lezen kan hier:
http://www.washingtonpost.com/wp-dyn/content/article/2010/06/28/AR201006...

Lees hier wat topcardioloog Harlan Krumholz over GSK zegt. :
A top cardiologist explains why GlaxoSmithKline's behavior upsets him..

http://www.forbes.com/2010/02/24/diabetes-glaxosmithkline-avandia-busine...

Job Pieter Tent ( )
afbeelding van Lisa
Re:Nieuw bewijs dat Avandia een gevaarlijk medicijn is

We hebben er toevallig vandaag weer een bericht over in het nieuws staan...
[url=http://hartgenoten.nl/nieuws/twee-nieuwe-studies-koppelen-avandia-gsk-aa... nieuwe studies koppelen Avandia (GSK) aan hartproblemen[/url]

precies hetzelfde dus :P

Lisa
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Re:Nieuw bewijs dat Avandia een gevaarlijk medicijn is

Job Pieter Tent schrijft:

Quote:

We hebben er toevallig vandaag weer een bericht over in het nieuws staan...
[url=http://hartgenoten.nl/nieuws/twee-nieuwe-studies-koppelen-avandia-gsk-aa... nieuwe studies koppelen Avandia (GSK) aan hartproblemen[/url]

precies hetzelfde dus :P

Nou en? Op het forum stond het bericht eerder ....En waarom steek je je tong er bij uit??

In het hartgenotennieuws is het wel in een Nederlandse vertaling, dat is dus niet "precies hetzelfde", maar wel zo prettig voor de mensen die moeite hebben met Engels lezen. (dat zijn er veel merk ik vaak op diverse fora waar ik kom).

Dus..... mooi toch zo?? ;)

Groetjes,
Lisa

Job Pieter Tent ( )
afbeelding van Lisa
Re:Nieuw bewijs dat Avandia een gevaarlijk medicijn is

Het tongetje was puur omdat je me weer te snel af bent ;)

Maar inderdaad hebben heel veel mensen moeite met Engels te lezen. Dat merk ik ook wel vaker.
Voor mij is het misschien zelfs iets te makkelijk. Ik heb namelijk in mijn hele jonge jaren :P een tijdje in Engeland gewoond.

Maar vaak is het ook nog zo dat mensen de titels niet begrijpen en zich nog niet eens wagen aan het lezen van het artikel.

Lisa
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460 miljoen dollar voor schadeclaims Avandia slikkers
Quote:

Glaxo Said to Pay $460 Million to Settle Avandia Damage Suits

Glaxo Smith Kline agreed to pay about $460 million to resolve a majority of lawsuits alleging the company’s Avandia diabetes drug can cause heart attacks and strokes, people familiar with the accords said.

Glaxo, the U.K.’s biggest drugmaker, agreed to settle about 10,000 suits for an average of at least $46,000 apiece, the people said. The company had been facing more than 13,000 suits alleging Glaxo hid the drug’s heart-attack risk, according to a UBS AG analyst. The settlements come as Glaxo is set to face its first Avandia trial in federal court in Philadelphia in October.

verder lezen kan hier:
http://www.bloomberg.com/news/2010-07-13/glaxosmithkline-is-said-to-pay-...

Lisa ( )
afbeelding van Lisa
FDA stemt over diabetes medicijn Avandia

www.Gezondescepsis.nl

Quote:

Het FDA panel dat 2 dagen lang heeft overlegd over het antidiabeticum rosiglitazon (Avandia) heeft geadviseerd het middel òf aan veel strictere banden te leggen, òf van de markt te halen. Over de vraag wat de FDA zou moeten doen stemden 12 van de 33 panelleden dat het van de markt moet. 10 stemden voor beperkte verkoop en versterking van de waarschuwingen op de verpakking.

F.D.A. Panel Votes to Restrict Avandia

By GARDINER HARRIS
Published: July 14, 2010

GAITHERSBURG, Md. — A federal medical advisory panel recommended Wednesday that Avandia, a controversial diabetes drug, should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.

The panel’s votes, taken after two days of intensive scientific discussions, were a blow to GlaxoSmithKline, which makes Avandia. The company argued that Avandia is a safe and needed option in treating diabetes.

But panel members voiced great skepticism about the company’s trustworthiness after questions were raised about its clinical trials. And internal company documents showed that the company for years kept crucial safety information about Avandia from the public.

Verder lezen kan hier:
http://www.nytimes.com/2010/07/15/health/policy/15diabetes.html?_r=1

Lisa
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Risico's Avandia waren al lang bekend

www.gezondescepis.nl:

Quote:

Producent GlaxoSmithKline weet uit eigen onderzoek sinds 1999 dat antidiabeticum rosiglitazon (Avandia) niet beter werkt dan pioglitazon (Actos) en meer cardiovasculair risico geeft. De resultaten van dit onderzoek zijn nooit gepubliceerd.

-----------------------------------------------------------------------------------------------------------

Diabetes Drug Maker Hid Test Data, Files Indicate

By GARDINER HARRIS
Published: July 12, 2010

In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

Verder lezen kan hier:
http://www.nytimes.com/2010/07/13/health/policy/13avandia.html?_r=1

Lisa
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FDA panellid die voor Avandia stemde werd betaald door Glaxo

Lisa schrijft:

<a href="http://www.Gezondescepsis.nl">www.Gezondescepsis.nl</a>
[quote
schreef:

Het FDA panel dat 2 dagen lang heeft overlegd over het antidiabeticum rosiglitazon (Avandia) heeft geadviseerd het middel òf aan veel strictere banden te leggen, òf van de markt te halen. Over de vraag wat de FDA zou moeten doen stemden 12 van de 33 panelleden dat het van de markt moet. 10 stemden voor beperkte verkoop en versterking van de waarschuwingen op de verpakking.

FDA Panelist (een endocrinoloog) die voor het op de markt houden van Avandia stemde wordt betaald door de maker van Avandia (Glaxo) (zo, zo, .....waarom verbaast mij dat niet?)

BY ALICIA MUNDY

WASHINGTON—One of the panelists who voted in favor of the diabetes drug Avandia at a Food and Drug Administration advisory meeting last week is a paid speaker for the drug's maker, GlaxoSmithKline PLC, according to the company and its records.

The panel voted 20-12 to keep Avandia on the market, though most of the members wanted stronger warnings.

Endocrinologist David Capuzzi of Philadelphia confirmed that he has been on Glaxo's speakers bureau for several years and said he doesn't see the relationship as a conflict.

Bron:
http://online.wsj.com/article/SB1000142405274870472000457537755260042193...

Lisa
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FDA panellid die voor Avandia stemde werd betaald door Glaxo

Lisa schrijft:

<a href="http://www.Gezondescepsis.nl">www.Gezondescepsis.nl</a>
[quote
schreef:

Het FDA panel dat 2 dagen lang heeft overlegd over het antidiabeticum rosiglitazon (Avandia) heeft geadviseerd het middel òf aan veel strictere banden te leggen, òf van de markt te halen. Over de vraag wat de FDA zou moeten doen stemden 12 van de 33 panelleden dat het van de markt moet. 10 stemden voor beperkte verkoop en versterking van de waarschuwingen op de verpakking.

FDA Panelist (een endocrinoloog) die voor het op de markt houden van Avandia stemde wordt betaald door de maker van Avandia (Glaxo) (zo, zo, .....waarom verbaast mij dat niet?)

BY ALICIA MUNDY

WASHINGTON—One of the panelists who voted in favor of the diabetes drug Avandia at a Food and Drug Administration advisory meeting last week is a paid speaker for the drug's maker, GlaxoSmithKline PLC, according to the company and its records.

The panel voted 20-12 to keep Avandia on the market, though most of the members wanted stronger warnings.

Endocrinologist David Capuzzi of Philadelphia confirmed that he has been on Glaxo's speakers bureau for several years and said he doesn't see the relationship as a conflict.

Bron:
http://online.wsj.com/article/SB1000142405274870472000457537755260042193...

Lisa ( )
afbeelding van Lisa
Re:FDA panellid die voor Avandia stemde werd betaald door Glaxo

Lisa schrijft:

www.Gezondescepsis.nl

Quote:

Het FDA panel dat 2 dagen lang heeft overlegd over het antidiabeticum rosiglitazon (Avandia) heeft geadviseerd het middel òf aan veel strictere banden te leggen, òf van de markt te halen. Over de vraag wat de FDA zou moeten doen stemden 12 van de 33 panelleden dat het van de markt moet. 10 stemden voor beperkte verkoop en versterking van de waarschuwingen op de verpakking.

FDA Panelist (een endocrinoloog) die voor het op de markt houden van Avandia stemde wordt betaald door de maker van Avandia (Glaxo) (zo, zo, .....waarom verbaast mij dat niet?)

BY ALICIA MUNDY

WASHINGTON—One of the panelists who voted in favor of the diabetes drug Avandia at a Food and Drug Administration advisory meeting last week is a paid speaker for the drug's maker, GlaxoSmithKline PLC, according to the company and its records.

The panel voted 20-12 to keep Avandia on the market, though most of the members wanted stronger warnings.

Endocrinologist David Capuzzi of Philadelphia confirmed that he has been on Glaxo's speakers bureau for several years and said he doesn't see the relationship as a conflict.

Bron:
http://online.wsj.com/article/SB1000142405274870472000457537755260042193...

PS 21 juli: wat raar, dit bericht is hier 2 maal geplaatst (ik weet niet hoe dat komt, niet goed opgelet zeker :laugh: )