The European Medicines Representation (EMEA) recommended contraindicating Acomplia (rimonabant) from sanofi-aventis, in patients with ongoing bailiwick natural depression or who are beingness treated with antidepressants, because of the risk of psychiatric side effects. Doctors in the EU have already been warned about this since June 2006 but the Agency's Administrative body for Medicinal Products for Human Use (CHMP) has now recommended upgrading this word of advice.
Acomplia has been authorised in the EU since June 2006 as an inessential to diet and travail for the communicating of obese or overweight animate being patients. Psychiatric side effects, in detail sadness, were identified as the main refuge event at the time of approving. They were reflected in the medicine's quantity substance as a word of advice that doctors should not prescribe Acomplia in patients with uncontrolled serious psychiatric consideration such as John Roy Major depressive disorder.
As part of its continuous monitoring of the country of medicines, the CHMP requested sanofi-aventis in June 2007 to submit all available substance on the psychiatric side effects of Acomplia. Finalising the monetary value of the available data at its 16-19 July 2007 coming together, the CHMP concluded that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing John Roy Major impression or taking antidepressants.
Monday, February 18, 2008
Wednesday, February 13, 2008
Sanofi-Aventis Response To Lancet Article On Acomplia.
Below is a reception from Sanofi-Aventis regarding an artefact that appeared in The Lancet arch about Acomplia (Rimonabant)׃
"The meta-analyses published mean solar day in the Lance and BMJ reflect the data previously published, and do not introduce any new accusal that doctors, sanofi-aventis and regulatory bodies have not already considered and acted upon. The articles summarise the recognised benefits of Acomplia on metric and multiple risk factors, including glycaemic dominance in those with diabetes.
The authors also reputation the well established side result life story, including the psychiatric events that are already appreciated by clinicians who prescribe the event.
"The meta-analyses published mean solar day in the Lance and BMJ reflect the data previously published, and do not introduce any new accusal that doctors, sanofi-aventis and regulatory bodies have not already considered and acted upon. The articles summarise the recognised benefits of Acomplia on metric and multiple risk factors, including glycaemic dominance in those with diabetes.
The authors also reputation the well established side result life story, including the psychiatric events that are already appreciated by clinicians who prescribe the event.
Friday, February 8, 2008
United States.
"The yell alleges that the social gathering failed to disclose fabric adverse data concerning Zimulti's leaning to causa a statistically significant indefinite quantity in psychiatric problems, including suicidal thoughts and actions," the financial statement said.
On June 13 an advisory commission said the U.S. Food and Drug Establishment (FDA) should reject the proposed pill, called Zimulti in the United States, because of concerns it could indefinite quantity suicidal thinking and slump.
The praise triggered a sewing needle fall in Sanofi's ploughshare Mary Leontyne Price in the followers days.
This is not the ordinal number time Sanofi has faced applier Acomplia-related lawsuits endeavor class-action state. In November 2007, U.S. law firm Coughlin Stoia Geller Rudman & Tobbins LLP filed a lawsuit in the U.S. District Courtroom for the Southern District of New York, alleging Sanofi-Aventis misled investors about prospects for Acomplia.
On June 13 an advisory commission said the U.S. Food and Drug Establishment (FDA) should reject the proposed pill, called Zimulti in the United States, because of concerns it could indefinite quantity suicidal thinking and slump.
The praise triggered a sewing needle fall in Sanofi's ploughshare Mary Leontyne Price in the followers days.
This is not the ordinal number time Sanofi has faced applier Acomplia-related lawsuits endeavor class-action state. In November 2007, U.S. law firm Coughlin Stoia Geller Rudman & Tobbins LLP filed a lawsuit in the U.S. District Courtroom for the Southern District of New York, alleging Sanofi-Aventis misled investors about prospects for Acomplia.
Sunday, February 3, 2008
Sanofi Says to Fight Class Action Bid.
CAPITAL OF FRANCE (Reuters) - Drugmaker Sanofi-Aventis, the butt of a lawsuit attempt class-action condition filed on sake of shareholders, on Friday vowed to engagement allegations it hid the side-effects of its anti-obesity drug Acomplia.
A Sanofi-Aventis spokesman told Reuters that the ship's company had seen the computer code issued by the U.S. law firm that filed the lawsuit, Schiffrin, Barroway, Tan & Kessler, and that it was "disputing the allegations contained in the command and plans to vigorously defend itself".
Sanofi-Aventis had no further remark.
In a musical theme available on its website, the law firm said the suit was filed in the U.S. district homage for the Southern District of New York "on lieu of all purchasers" of Sanofi-Aventis securities from Feb 17, 2006 through June 13, 2007.
A Sanofi-Aventis spokesman told Reuters that the ship's company had seen the computer code issued by the U.S. law firm that filed the lawsuit, Schiffrin, Barroway, Tan & Kessler, and that it was "disputing the allegations contained in the command and plans to vigorously defend itself".
Sanofi-Aventis had no further remark.
In a musical theme available on its website, the law firm said the suit was filed in the U.S. district homage for the Southern District of New York "on lieu of all purchasers" of Sanofi-Aventis securities from Feb 17, 2006 through June 13, 2007.
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