Recent news on Telithromycin

Ketek Linked to Liver Damage, Approval Process Flawed  -  May 9, 2007
Lawyers and Settlements,Finally approved in 2004 after two failed attempts, Ketek (telithromycin) is a class of antibiotic prescribed to treat bacterial infections.

European Medicines Agency Recommends Restricted Use And ...  -  Mar 30, 2007
Medical News Today (press release),The European Medicines Agency (EMEA) has recommended restrictions on the use of Ketek (telithromycin) in three of its four approved indications.

Officials from sanofi-aventis recently report on new developments  -  Apr 12, 2007
Therapeutics Daily (subscription) (press release),...today announced that the US Food and Drug Administration (FDA) has approved revisions to the US Prescribing Information for Ketek(R) (telithromycin).

European Medicines Agency Recommends Restricted Use and ...  -  Mar 30, 2007
PharmaLive.com (press release),LONDON, March 30, 2007-The European Medicines Agency (EMEA) has recommended restrictions on the use of Ketek (telithromycin) in three of its four approved

Health Canada - Note to editors  -  Apr 10, 2007
Canada NewsWire (press release),...and a case presentation on telithromycin, a drug used to treat respiratory tract infections, and its suspected association with a serious skin disorder.

EU Drug Watchdog Warns on Use of Sanofi Antibiotic  -  Mar 30, 2007
Reuters.uk,Ketek, known generically as telithromycin, already comes with a warning for possible liver damage. Shares of Paris-based Sanofi were 0.9 percent lower at

EU drug watchdog warns on use of Sanofi antibiotic  -  Mar 30, 2007
Reuters...sparked a debate over the drug's safety. Ketek, known generically as telithromycin, already comes with a warning for possible liver damage. Continued

Letter Outlines Revised Labeling for Ketek  -  Mar 28, 2007
Facts and Comparisons,Sanofi-Aventis has issued a letter to health care professionals notifying them of revised labeling for Ketek (telithromycin) that includes a boxed warning

Ketek — The FDA Perspective  -  Apr 18, 2007
New England Journal of Medicine (subscription),...to the article by Ross in this issue of the Journal, 1 we wish to clarify how the Food and Drug Administration (FDA) reviewed Ketek (telithromycin).

The FDA and the Case of Ketek  -  Apr 18, 2007
New England Journal of Medicine (subscription),Three years ago, the Food and Drug Administration (FDA) approved the drug Ketek (telithromycin), lauding it as the first of a new class of antimicrobial

Use of Sanofi-Aventis' Ketek restricted further by the EU  -  Apr 2, 2007
Pharma Times (subscription),The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has proposed restrictions on the use of Ketek (telithromycin),

Sanofi-Aventis Announces Update to US Prescribing Information for ...  -  Feb 15, 2007
Drug Newswire (press release),Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin.

New Limits to Ketek Use, FDA Says  -  Feb 13, 2007
Medscape (subscription)February 13, 2007 — Multiple label revisions for telithromycin (Ketek tablets, made by Sanofi-Aventis) include removal of its approval for 2 of its 3

FDA Revises Label Warnings On The Antibiotic Ketek  -  Feb 13, 2007
Medical News Today,Telithromycin (the generic name for Ketek) is a ketolide antibiotic with a similar structure to one of the macrolides - Erythromycin.

Antibiotic Ketek more dangerous than thought  -  Feb 12, 2007
Food Consumer,The Food and Drug Administration (FDA) today announced its new decision to restrict use of antibiotic Ketek (Telithromycin) based on reports of severe

Serious warning placed on antibiotic Ketek  -  Feb 12, 2007
News-Medical.net,Ketek, known generically as telithromycin, already carried a bold warning for possible liver damage and has been linked to 14 cases of severe liver problems

FDA restricts use of antibiotic  -  Feb 12, 2007
Jordan Falls News,...are in line with the December recommendations of a panel of FDA expert advisers that the agency modify the label of the drug, also called telithromycin.

FDA Limits Use of Sanofi-Aventis's Drug  -  Feb 14, 2007
Seeking Alpha,Mark Senak submits: The FDA announced the issuance of a new label for Ketek (telithromycin) that strips away two indications for use of the drug - acute

FDA limits use of antibiotic after 4 deaths  -  Feb 13, 2007
Newsday,A new "black box" warning on Ketek's (telithromycin) label indicates patients with the muscle disease myasthenia gravis should not use it.

Sanofi profits hit by generic Plavix and 2007 looks tougher  -  Feb 13, 2007
Pharma Times (subscription),...that it has again delayed its review of the obesity drug Acomplia (rimonabant) and further restricted the use of its antibiotic Ketek (telithromycin).

FDA Limits Use of Controversial Antibiotic  -  Feb 13, 2007
HealthCentral.com,Ketek (generic name telithromycin) is getting the black-box warning, the strongest available, stating that it should not be used in patients with myasthenia

FDA Approves Antibiotic Label Changes  -  Feb 12, 2007
International News Service,The US Food and Drug Administration ordered revised labeling for the antibiotic Ketek (telithromycin) to improve the safe use of the drug.

FDA Announces Label, Indication Changes for Antibiotic Ketek  -  Feb 12, 2007
Therapeutics Daily (subscription) (press release),...(FDA) on Monday announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients.

FDA approves antibiotic label changes  -  Feb 12, 2007
United Press International12 (UPI) -- The US Food and Drug Administration ordered revised labeling for the antibiotic Ketek (telithromycin) to improve the safe use of the drug.

FDA Announces Label and Indication Changes for the Antibiotic Ketek  -  Feb 21, 2007
Pharmaceutical Processing,The FDA recently announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients.

‘PPD knew about Ketek clinical trial fraud’ – claims former employee  -  Feb 21, 2007
OutSourcing-Pharma.com,...data included in the study 3014 of Ketek (telithromycin) and there were also problems at the site but said neither of the companies took any action.

Lifestyle in brief  -  Feb 20, 2007
Alberta Daily Herald Tribune (subscription),The changes are in line with the December recommendations of a panel of FDA advisers that the agency modify the label of the drug, also called telithromycin

FDA Announces Label and Indication Changes for the Antibiotic Ketek  -  Feb 15, 2007
Infection Control Today,The Food and Drug Administration (FDA) announces revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of

FDA Announces Label And Indication Changes For The Antibiotic Ketek  -  Feb 15, 2007
Medical News Today (press release),The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use

Sanofi-Aventis: FDA restricts Ketek's commercial opportunity  -  Feb 14, 2007
Pharmaceutical Business Review...'Content The FDA announced that the label of Sanofi-Aventis' antibiotic Ketek (telithromycin) would be limited following reports of four deaths and rare but

Analysis: Critics blast FDA culture  -  Feb 13, 2007
Science Daily (press release)2007) -- The US Food and Drug Administration ordered revised labeling for the antibiotic Ketek (telithromycin) to improve the safe use of the drug.

Revised Ketek Labeling  -  Feb 13, 2007
Facts and Comparisons,The FDA has approved revised labeling for Sanofi-Aventis’ Ketek (telithromycin) to include a Boxed Warning alerting physicians and patients that the drug’s

FDA delays review on Acomplia again and acts on Ketek  -  Feb 13, 2007
Pharma Times (subscription),As if this further delay for Acomplia was not bad enough, the FDA said that Sanofi's antibiotic Ketek (telithromycin), which the agency approved in 2004,

FDA limits use of risky Sanofi antibiotic Ketek  -  Feb 12, 2007
Scientific AmericanKetek, known generically as telithromycin, already comes with a bold warning for possible liver damage. Jenkins said officials saw no need to strength it.

FDA Announces Label and Indication Changes for the Antibiotic Ketek  -  Feb 12, 2007
DG News2007 -- The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve

FDA Announces Label and Indication Changes for Antibiotic Ketek  -  Feb 12, 2007
Newsinferno.com,Citing various safety issues, the US Food and Drug Administration (FDA) has changed the approved usages for the antibiotic Ketek (telithromycin).

FDA restricts use of Sanofi-Aventis antibiotic  -  Feb 12, 2007
El Paso Times,...of FDA expert advisers that the agency modify the label of the drug, also called telithromycin. In 17-2 votes, the outside advisers said the drug's benefits

FDA Revises Use and Labeling Of Antibiotic Ketek  -  Feb 12, 2007
All Headline News...announced Monday it has issued revised usage and labeling of the antibiotic drug Ketek (generic name: telithromycin), manufactured by Sanoti-Adventis.

FDA Subtracts Two Indications for Ketek  -  Feb 12, 2007
MedPage Today,12 -- The FDA announced today that concerns about toxicity had led it to rescind two indications for the antibiotic Ketek (telithromycin).

(AP) FDA Restricts Use of Antibiotic  -  Feb 12, 2007
WKRN,...advisers that the agency modify the label of the drug, also called telithromycin. In 17-2 votes, the outside advisers said the drug's benefits don't

FDA Announces Label and Indication Changes for the Antibiotic Ketek  -  Feb 12, 2007
PharmaLive.com (press release),12, 2007-The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the

FDA Restricts Use of Antibiotic  -  Feb 12, 2007
Business Portal 24 (press release),...recommendations of a panel of FDA expert advisers that the agency modify the label of the drug, also called telithromycin. In 17-2 votes,

The Bush Administration's FDA  -  18 Jan 2007
Dissident Voice,The approval of the antibiotic, Ketek (telithromycin), is another example where the FDA accommodated a drug company, and in this case, despite the fact that

Faropenem Phase III Clinical Trial Stopped to Consider Exclusion ...  -  Jan 3, 2007
PipelineReview.com (press release),Reported today that the current phase III clinical trial comparing faropenem medoxomil (faropenem) to placebo and Ketek (telithromycin) in patients being

Replidyne Temporarily Halts Phase III Trial  -  Dec 26, 2006
Genetic Engineering News (press release),...the FDA’s Advisory Committee found that in the study, which is comparing faropenem medoxomil (faropenem) to placebo and Ketek (telithromycin),

Greater LDL Cholesterol Reduction with VYTORIN Compared to Lipitor ...  -  Dec 21, 2006
Business Wire (press release),If treatment with itraconazole, ketoconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with VYTORIN should be suspended during

Sanofi-Aventis Statement Regarding US FDA Joint Advisory Committee ...  -  Dec 17, 2006
Drug Newswire (press release),KETEK(R) (telithromycin) is indicated in the current labeling for the treatment of infections caused by susceptible strains of the designated microorganisms

FDA studying Ketek antibiotic  -  Dec 14, 2006
CBC British Columbia,Ketek, the brand name for telithromycin, is used to treat some types of pneumonia, throat and sinus infections, and exacerbation of chronic bronchitis.

Sanofi-Aventis Statement Regarding US FDA Joint Advisory Committee ...  -  Dec 16, 2006
Therapeutics Daily (subscription) (press release),...positive benefit-risk profile and recommended continued marketing of Ketek(R) (telithromycin) in mild to moderate community acquired pneumonia (CAP),

Studies support Sanofi antibiotic  -  Dec 14, 2006
Scientific AmericanKetek, also known as telithromycin, began raising concerns earlier this year after researchers found cases of liver problems and death in some patients

US panel backs limiting Sanofi antibiotic uses  -  Dec 15, 2006
ReutersThe top news, photos, and videos of 2006. Full Coverage. The agency approved Ketek, also known generically as telithromycin, in 2004.

US panel backs limiting Sanofi antibiotic uses  -  Dec 15, 2006
ReutersThe FDA will make the final decision but usually takes the advice of its advisory panels. The agency approved Ketek, also known generically as telithromycin

FDA moves to limit availability of Sanofi's Ketek  -  Dec 18, 2006
Pharma Times (subscription),...joint advisory committee said it recognised the positive benefit-risk profile and recommended continued marketing of Ketek (telithromycin) in mild to

Advisers Suggest Restricting Antibiotic  -  Dec 18, 2006
Wyoming News,Sanofi-Aventis said the risks associated with the drug, also known as telithromycin, appear to be comparable to those of other similar drugs and that it

US Panels Begin Hearings on Antibiotic's Safety  -  Dec 16, 2006
Food Consumer,In testimony before two US Food and Drug Administration advisory panels, representatives of Sanofi-Aventis, which manufactures Ketek (telithromycin),

FDA Panel Hits Antibiotic For Bronchitis, Sinusitis  -  Dec 16, 2006
Atlanta Journal Constitution (subscription),At the end of the second day, the committees voted 16-to-3 that the benefits of Ketek (telithromycin) outweighed the risks for community-acquired pneumonia,

Ketek May Well Lose Sinusitis And Bronchitis Approval, FDA  -  Dec 16, 2006
Medical News Today,Ketek (telithromycin), an antibiotic used to combat pneumonia, as well as treating bronchitis and sinusitis, got an unfavorable review from an FDA Advisory

Drug Maker Takes Issue With FDA Panel  -  Dec 15, 2006
New York Times,The agency will make the final decision but usually takes the advice of its advisory panels. It approved Ketek, also known generically as telithromycin,

FDA panel backs Sanofi drug for pneumonia  -  Dec 15, 2006
MarketWatchOther problems reported by patients taking Ketek, also known as telithromycin, include blurred vision. But the panel recommended 17 to 2 against the

FDA panel urges limits on Sanofi antibiotic  -  Dec 15, 2006
KPLC-TV,Ketek, known generically as telithromycin, binds to two sites on bacteria to stop them from reproducing. Similar, older drugs called macrolides attach to

FDA Advisers Recommend Limits for Ketek Antibiotic  -  Dec 15, 2006
MedPage Today,15 -- Two FDA advisory committees agreed today that the antibiotic Ketek (telithromycin) should be limited to second-line therapy for community-acquired

Analysis: Controversial antibiotic debated  -  Dec 14, 2006
Science Daily (press release)The company argued Thursday that the injuries occurred over 6 million uses of Ketek, and that the drug, known generically as telithromycin, carries about

Sanofi-Aventis Defends Ketek's Safety to US Panels (Update2)  -  Dec 14, 2006
Bloomberg...including about 6 million people in the US The $6 pills, known chemically as telithromycin, are given in 800- milligram doses once a day, for five to 10

Study of Dasatinib or 800 Mg of Imatinib Mesylate Shows Patients ...  -  Dec 14, 2006
DG News...ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, atazanavir, indinavir, nefazodone, nelfinavir, saquinavir, and telithromycin).

Greater LDL Cholesterol Reduction with VYTORIN Compared to Lipitor ...  -  Dec 21, 2006
Business Wire (press release),If treatment with itraconazole, ketoconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with VYTORIN should be suspended during

US senator says needs more FDA info on antibiotic  -  Nov 30, 2006
ReutersKetek, whose generic name is telithromycin, had US sales for the first half of 2006 estimated at $50 million. Grassley is one of three Republicans who are

Foro de Shell Security - Seguridad informática  Oct 26, 2006
Sup tegretol ression of hematopoiesis is likely mediated by an e telithromycin panded population of the following cytotoxic T lympho telmisartan ytes (CTLs ... -Shell Security, Sanofi-Aventis Updates Ketek Safety Info In Canada  Oct 30, 2006
Ketek, whose generic name is telithromycin, is the first of a new family of antimicrobial drugs known as ketolides, which have been developed to kill strains ... -Easy Bourse (Communiqués de presse), Severe Hepatotoxicity of Telithromycin  Sep 18, 2006
In case 1, the patient started to notice dark urine on day 2 of treatment with telithromycin. When his wife noted continued symptoms ... -Annals of Internal Medicine

Drug-induced hepatotoxicity: Acetaminophen, Ketek  Sep 1, 2006
...factors become evident. Take Ketek ( Telithromycin ), for example, an antibiotic used to treat respiratory infections. A report ... -Xagena.it

STUDY SHOWS SPRYCEL(R) (DASATINIB) 100 MG ONCE A DAY PROVIDES ...  -  Dec 11, 2006
PR Newswire (press release),...eg, ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, atazanavir, indinavir, nefazodone, nelfinavir, saquinavir, and telithromycin). ...

US FDA scientist questions Sanofi antibiotic use  -  Nov 22, 2006
ReutersKnown generically as telithromycin, the drug has come under scrutiny following a dozen reports of liver failure that included four deaths. ...

US senator says needs more FDA info on antibiotic  -  Nov 30, 2006
ReutersFour were fatal. Ketek, whose generic name is telithromycin, had US sales for the first half of 2006 estimated at $50 million. Grassley ...

The Committee gave positive opinions for applications for ...  -  Nov 21, 2006
Easy Bourse (Communiqués de presse),The Committee recommended to add a contraindication for Ketek and Levviax (telithromycin), from Aventis Pharma SA, saying that Ketek or Levviax must not be ...

FDA Subjects Antibiotic to New Scrutiny  -  Nov 14, 2006
ABC NewsKetek, also called telithromycin, already carries a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal, in ...

US FDA to seek outside review of Sanofi antibiotic  -  Nov 14, 2006
ReutersThe drug's generic name is telithromycin. In June, the FDA said it had received 12 reports of acute liver failure in Ketek patients, including four deaths. ...

FDA to Seek Advice of Expert Panel on Safety of Sanof-Aventis Drug  -  Nov 14, 2006
New York Times,Ketek, whose chemical name is telithromycin, had United States sales for the first half of 2006 estimated at $50 million, Sanofi said in June. ...

Sanofi-Aventis Updates Ketek Safety Info In Canada  -  Nov 16, 2006
Easy Bourse (Communiqués de presse),Ketek, whose generic name is telithromycin, is the first of a new family of antimicrobial drugs known as ketolides, which have been developed to kill strains ...

Committee for Medicinal Products for Human Use Post-authorisation ...  -  Nov 17, 2006
PharmaLive.com (press release),...indication adopted by CHMP is: "Levviax must not be used in patients with previous history of hepatitis and/or jaundice associated with the use of telithromycin ...

Antibiotic Telithromycin linked to severe hepatotoxicity  Aug 11, 2006
...of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek ( Telithromycin ). ... -Xagena.it

Lawmakers Say FDA Better Clean Up Its Act  Aug 21, 2006
..."It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned," Dr David Graham wrote ... -Scoop.co.nz

Rimonabant, a new drug for weight loss  Aug 22, 2006
...should be used with caution in combination with potent CYP3A4 inhibitors ( eg Ketoconazole, Itraconazole, Ritonavir, Telithromycin, Clarithromycin, Nefazodone ... -Xagena.it

Discontinuation of Marketing Alliance on Ketolide Antibiotics ...  Aug 21, 2006
...both companies agreed to discontinue the marketing alliance on September 30, 2006 for "Ketek Tablets 300 mg" (generic name: telithromycin), ketolide antibiotic ... -PharmaLive.com

JAMA scandal and Ketek approval raise questions about big pharma's ...  Aug 1, 2006
..."It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin [Ketek] is concerned," he recently ... -OpEdNews



Off Label Drug Use  May 9, 2006
For instance we saw that telithromycin is effective in exacerbations of asthma. That was totally a surprise. And of course that ... - ABC 4

Sanofi antibiotic may alleviate asthma  Apr 18, 2006
Results from a multinational study published in the New England Journal of Medicine show that Sanofi's telithromycin antibiotic, sold under the brand name Ketek ... - Pharmaceutical Business Review

Markey criticizes FDA  May 3, 2006
A February study in the Annals of Internal Medicine said three previously healthy patients who took Ketek, also known as telithromycin, developed liver damage. ... - Milford Daily News

FDA under fire over Ketek approval  May 2, 2006
They claim that the Food and Drug Administration was wrong to approve the drug because a major safety trial of Ketek (telithromycin) had 'data integrity ... - Pharma Times (subscription)

Reps. Launch Investigation of Popular Antibiotic, Ketek  May 2, 2006
Committee, sent a letter today to the Food and Drug Administration (FDA) questioning actions surrounding its approval of the antibiotic telithromycin (Ketek). ... - PharmaLive.com

Antibiotic's results mixed for asthma  Apr 17, 2006
The study, published in last week's New England Journal of Medicine, found that 278 adults who took the antibiotic telithromycin — sold by Sanofi-Aventis ... - Los Angeles Times

HealthWrap: China's New Fast-Food Nation  Apr 16, 2006
A study published April 13 in the New England Journal of Medicine tested the effectiveness of the antibiotic Telithromycin, which proved to be effective in ... - National Ledger

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