Recent news on Ketek

Frustrated House panel threatens to subpoena FDA  -  25 May 2007
Washington Post,...an outbreak of salmonella in peanut butter, post-market surveillance of the antibiotic Ketek, contamination of pet food with ingredients imported from

Why all the side effects with a simple sinus drug? Nesita Kwan ...  -  May 22, 2007
NBC5.com,The drug was Ketek, a new antibiotic for bronchitis and sinus infections that the Food and Drug Administration now associates with the deaths of four people

Ketek Linked to Liver Damage, Approval Process Flawed  -  May 9, 2007
Lawyers and Settlements,As recently as February 12th of this year, the FDA reduced by two the approved uses for Ketek, and required the manufacturer to add a black box warning

Antibiotic under review amid safety warnings  -  May 7, 2007
Canada.com,Toxic epidermal necrolysis occurs in as few as one in a million people and Ketek is only suspected in the woman's case. She also had a history of allergic

Simple drug leads to horrific reaction  -  May 7, 2007
Victoria Times Colonist,Jim Wright, a professor at the University of British Columbia, says that the drug Ketek can be fatal in some people. He believes that the drug should be

Senators weigh bill to bolster drug safety  -  Apr 30, 2007
Newark Star Ledger,This has included antidepressants, the antibiotic Ketek and the withdrawn painkiller Vioxx, a once-popular Merck drug that was linked to heart attacks and

Govt urged to speed tidal wave warning system  -  May 21, 2007
Jakarta Post,Aside from causing damage to several houses, the waves destroyed a turtle conservation berth on Karabek Ketek island, near South Pesisir regency.

sanofi-aventis: Full-year Guidance Raised on Good 2007 First ...  -  May 3, 2007
Earthtimes.orgNet sales of the antibiotic Ketek(R) halved year-on-year (to euro 30 million, from euro 59 million(5) in the first quarter of 2006) due to restrictions on

Parker Waichman Alonso Mark LLP Retained by Hundreds to ...  -  Apr 30, 2007
Primenewswire (press release),The firm is currently representing individuals injured by Guidant and Medtronic Defibrillators, Drug Coated Coronary Stents, Ortho Evra, Ketek,

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

Ketek — The FDA Perspective  -  Apr 18, 2007
New England Journal of Medicine (subscription),Finally, noninferiority studies were considered acceptable as the basis for approval for treatment of certain respiratory infections when the Ketek New Drug

Taking Ketek a Second Time might be the Last Time  -  Apr 8, 2007
Lawyers and Settlements,Mount Vernon, IL: John Hammond was prescribed Ketek for a sinus infection but after taking it for a few days he wound up in hospital due to elevated liver

Ketek: Sales Reps Push Profits over Safety  -  Apr 3, 2007
Lawyers and Settlements,..."My doctor prescribed Ketek for a sinus infection that was not responsive to other antibiotics and Ketek seemed to be the hot new drug at the time;

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),

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.

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

Sanofi Issues Warning Letter About Ketek  -  Mar 27, 2007
Newsinferno.com,It is important to note that Ketek continues to be indicated only for the treatment of community-acquired pneumonia (CAP) of mild to moderate severity.�

Sanofi's Ketek side-effect warning strengthened by European ...  -  Mar 30, 2007
Forbes,In a statement, the group said EMEA's Committee for Medicinal Products for Human use (CHMP) concluded that the effectiveness of Ketek has been confirmed in

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

Inactivated heterologous on whom was later determined.  -  Apr 19, 2007
LIVE-Wintersport.com,Pays for further reported Glipizide occur rarely Ketek shed in Mirtazapine tomorrow. Polymorphism of are identified rate by mentioned.

EU Drug Watchdog Warns on Use of Sanofi Antibiotic  -  Mar 30, 2007
Reuters.uk,Ketek remains suitable, however, for the treatment of community-acquired pneumonia without such restrictions, the London-based agency said.

EU drug watchdog warns on use of Sanofi antibiotic  -  Mar 30, 2007
ReutersPA: Quote, Profile, Research) antibiotic Ketek. The move follows similar restrictions announced by US regulators last month.

Democrats question accuracy of FDA chief's testimony  -  Apr 5, 2007
Leesville Daily Leader,WASHINGTON (AP) - House Democrats are investigating whether FDA Commissioner Andrew von Eschenbach lied under oath about the antibiotic Ketek,

IowaPolitics.com: Even In Minority, Grassley Relishes Oversight Role  -  Apr 9, 2007
IowaPolitics.com (press Release),...“The FDA approved Ketek for the marketplace using falsified clinical data. Now the drug is linked to adverse effects, including abnormal liver function.�

Democrats question accuracy of US medical agency chief's testimony  -  Mar 30, 2007
International Herald Tribune,The Food and Drug Administration approved Ketek in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia.

Dems question FDA chief's testimony  -  Mar 30, 2007
Kansas City Star,WASHINGTON - House Democrats are investigating whether FDA Commissioner Andrew von Eschenbach lied under oath about the antibiotic Ketek, which has long

Dems Question FDA Chief's Testimony  -  Mar 30, 2007
Examiner.comWASHINGTON (Map, News) - House Democrats are investigating whether FDA Commissioner Andrew von Eschenbach lied under oath about the antibiotic Ketek,

Dems question FDA chief's testimony  -  Mar 30, 2007
The Olympian,House Democrats are investigating whether FDA Commissioner Andrew von Eschenbach lied under oath about the antibiotic Ketek, which has long been under

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).

Another Successful Levin Papantonio and Mass Torts Made Perfect ...  -  Apr 2, 2007
PharmaLive.com (press release),Accutane, Fosamax, Ketek, Ortho Evra, ReNu with MoistureLoc, Trasylol and Vioxx and Tobacco litigation are among a few of the cases the Levin Papantonio law

DJ MARKET COMMENT: European Stocks Lower  -  Mar 30, 2007
Onet.pl,And French drugmaker Sanofi-Aventis said a committee for the European Medicines Agency has called for changes to the label for antibiotic Ketek.

EU drug watchdog warns on use of Sanofi antibiotic  -  Mar 30, 2007
ReutersKetek remains suitable, however, for the treatment of community-acquired pneumonia without such restrictions, the London-based agency said.

Adding bite to FDA screening  -  Apr 17, 2007
Boston Globe,...deadly results are all too familiar: think of drugs like Vioxx, Trasylol, and Ketek, and devices such as drug-eluting stents and defibrillators.

FDA Issues New Conflict of Interest Guidelines  -  Apr 4, 2007
OMB WatchThe hearing revisited the 2006 controversy over the antibiotic Ketek, which was rushed to market despite warnings from agency scientists about the drug's

Paris shares turn positive as Wall St opens up on back of strong ...  -  Mar 30, 2007
Forbes,The drug company reversed an earlier loss that followed the news the European Medicines Agency (EMEA) has updated its guidelines for the group's Ketek

Paris shares down at midday amid profit-taking, rising oil prices  -  Mar 30, 2007
Forbes,Sanofi said that the European Medicines Agency (EMEA) has updated its indications for use of the group's Ketek antibiotic, prohibiting its use for patients

Business briefs, March 28  -  Mar 27, 2007
Rocky Mountain News,The Louisville-based biopharmaceutical company in December stopped a study on the drug to consider excluding the comparison to another antibiotic, Ketek.

FDA Orders Changes To Ketek But Leaves It On The Market  -  27 Mar 2007
Lawyers and Settlements,Rockville, MD: The US Food and Drug Administration (FDA) is making changes to the labeling of Ketek following pressure from numerous organizations regarding

Study finds overuse of drugs for sinuses  -  27 Mar 2007
Newsday,Last month, the Food and Drug Administration announced restrictions on the antibiotic Ketek, after reports of four deaths and rare but serious liver injury

FDA Hounded Over Ketek Scandal  -  Mar 19, 2007
Lawyers and Settlements,Washington, DC: The new drug application for the antibiotic, Ketek, was rejected twice, in 2001 and 2003, before FDA management approved the drug on April 1

FDA Chief Defends Agency Openess, Industry Fees  -  Mar 23, 2007
Medscape (subscription)Concerns over drug safety were renewed after Sanofi's antibiotic Ketek was linked to liver failure. In February, the FDA revoked the drug's approval for

'The problem is the perception'  -  Mar 22, 2007
Minneapolis Star Tribune (subscription),He traveled the country speaking to groups of doctors about sinusitis for Sanofi-Aventis, which was promoting an antibiotic called Ketek, he said.

FDA chief vows to defend whistle-blowers  -  Mar 23, 2007
Howell Times and Transcript,...agency has retaliated against employees who spoke out about safety issues with the now-withdrawn painkiller Vioxx , antibiotic Ketek and other drugs.

Lawmakers Get Whistle-Blower Vow  -  Mar 22, 2007
Washington Post,...the agency has retaliated against employees who spoke out about safety issues with the now-withdrawn painkiller Vioxx, antibiotic Ketek and other drugs.

Full Text  -  Mar 22, 2007
Science Magazine (subscription)...that the agency ignored data on liver damage in patients before approving the antibiotic Ketek in 2004 have spawned a congressional investigation.

Advanced Life Sciences' antibiotic nears OK  -  Feb 27, 2007
Chicago Sun-Times,Cethromycin would compete against Sanofi-Aventis' antibiotic Ketek, which has been used to treat an estimated 28 million people. Ketek, which was approved

Behind the Scenes Snake Oil Salesmen  -  Mar 7, 2007
Lawyers and Settlements,One of the latest cases of a drug company concealing a drug's dangerous adverse events and lack of efficacy, involves the antibiotic, Ketek,

Embattled FDA chief fights back  -  Mar 3, 2007
Houston Chronicle,The agency also restricted the use of Ketek for treatment of pneumonia. The administration has proposed adding $10 million in next year's budget for more

Lawmakers blast FDA for censorship, negligence regarding unsafe drugs  -  Mar 16, 2007
TransWorldNews (press release),The hearing focused on the FDA's handling of a Sanofi-Aventis antibiotic, called Ketek, and several prescription anti-depressants. Problems with these drugs

Sleep-blogging  -  Mar 15, 2007
Huffington Post,Fittingly, former FDA bosses Jane Henney (Vioxx) and Mark McClellan (Ketek) can claim sleep-approving. Dr. Sandeep Kapoor isn't responsible for

FDA Commissioner 'Committed' To Protecting Whistleblowers' Rights ...  -  Mar 23, 2007
Kaiser network.org,The agency has come under fire for allegedly retaliating against employee whistleblowers who spoke out about safety concerns with Vioxx, Ketek and other

Levin, Papantonio and Mass Torts Made Perfect, Inc. Announce ...  -  Mar 13, 2007
PharmaLive.com (press release),Accutane, Fosamax, Ketek, Ortho Evra, ReNu with MoistureLoc, Trasylol and Vioxx and Tobacco litigation are among a few of the cases the Levin Papantonio law

Von Eschenbach Offers Assurances on Whistleblowers  -  Mar 22, 2007
Congressional Quarterly,Ross said he tried to express his concerns about the safety of the antibiotic Ketek internally but a superior “blew it off.� Ross said, “I went inside the

Reps. Waxman and Markey Introduce Counterpart to Enzi-Kennedy Drug ...  -  Mar 21, 2007
PharmaLive.com (press release),...“In the wake of Vioxx, Paxil, Ketek and other drug scandals, Congress needs to act now to improve drug safety at FDA,� Rep. Markey said.

Rep. Waxman And Rep. Markey Introduce Counterpart To Enzi-kennedy ...  -  Mar 20, 2007
YubaNet,..."In the wake of Vioxx, Paxil, Ketek and other drug scandals, Congress needs to act now to improve drug safety at FDA," Rep. Markey said.

Call To End FDA User Fees And Improve Drug Safety  -  Mar 17, 2007
Medical News Today (press release),...not include the provisions necessary to prevent another Vioxx, Accutane, or Ketek from reaching the market and harming patients and their families.

Industry Insider: Senator spars with FDA chief over whistle-blower ...  -  Mar 14, 2007
Newark Star Ledger,...from the market in 2004, and the antibi otic Ketek, which just recently had a labeling change greatly limiting its use because of serious side ef fects.

Levin Papantonio Presents LPtv Online Video Media Center  -  Mar 9, 2007
Primenewswire (press release),The online video media center currently addresses dangerous drug news such as Accutane, Fosamax, Ketek, Stevens-Johnson Syndrome and Trasylol.

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,21/02/2007 - The Ketek saga continues as a former employee of Pharmaceutical Product Development (PPD) has claimed that Aventis and PPD – the contract

Sanofi-Aventis Announces Update to US Prescribing Information for ...  -  Feb 15, 2007
Drug Newswire (press release),Ketek(R), when used as directed in its approved indication continues to be an important option in the anti-infective armamentarium and helps to satisfy a

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

Sanofi-Aventis: FDA restricts Ketek's commercial opportunity  -  Feb 14, 2007
Pharmaceutical Business ReviewThe FDA has removed two out of three indications from the US label of Sanofi-Aventis' antibiotic Ketek following an analysis of the risks and benefits of

Ketek antibiotic to carry black box warning, new use limitations ...  -  Feb 15, 2007
TransWorldNews (press release),The FDA has strengthened its warnings on the controversial antibiotic Ketek and banned the drug's use for treatment of sinusitis and bronchitis.

Sanofi-Aventis Announces Update To US Prescribing Information For ...  -  Feb 13, 2007
Medical News Today (press release),Sanofi-aventis today announced that the US Food and Drug Administration (FDA) has approved revisions to the US Prescribing Information for Ketek(R)

Ketek case keeps glare on reform  -  Feb 14, 2007
Trenton Times,WASHINGTON--The Food and Drug Administration's missteps in approving the controversial antibiotic Ketek were cited at a congressional hearing yesterday as

Analysis: FDA pares Ketek indications  -  Feb 12, 2007
Science Daily (press release)12 (UPI) -- The US Food and Drug Administration curbed the approved uses of the Sanofi-Aventis antibiotic Ketek Monday and also said it would issue new

Vioxx whistle-blower weighs in on demoted antibiotic Ketek  -  Feb 13, 2007
USA Today..."I'm disappointed that neither the FDA nor the manufacturer of Ketek … were invited to tell their side," said Rep. Michael Burgess, R-Texas,

FDA pares Ketek indications  -  Feb 13, 2007
Monsters and Critics.com,WASHINGTON, DC, United States (UPI) -- The US Food and Drug Administration curbed the approved uses of the Sanofi-Aventis antibiotic Ketek Monday and also

Sanofi's Ketek Is Restricted by US Before Hearing (Update6)  -  Feb 12, 2007
Bloomberg12 (Bloomberg) -- Sanofi-Aventis SA was banned from selling its Ketek antibiotic in the US for bronchitis and sinusitis a day before lawmakers debate the

Sanofi-Aventis Announces Update to US Prescribing Information for ...  -  Feb 12, 2007
Yahoo! News (press release)Ketek® remains indicated in patients with mild to moderate community- acquired pneumonia (CAP) caused by susceptible pathogens, including multidrug-

FDA Restricts Use of Antibiotic Ketek  -  Feb 13, 2007
Sci-Tech TodayThe FDA's new "black-box" warning on the Ketek label states the antibiotic should not be used in patients with myasthenia gravis, a disease that can cause

FDA limits use of risky Sanofi antibiotic Ketek  -  Feb 12, 2007
Scientific AmericanWASHINGTON (Reuters) - Sanofi-Aventis SA's antibiotic Ketek should no longer be used to treat sinusitis and bronchitis, US officials warned on Monday,

FDA Revises Label Warnings On The Antibiotic Ketek  -  Feb 13, 2007
Medical News Today,The US Food and Drug Administration (FDA) has revised the label warnings on the antibiotic Ketek, to improve safe use by patients. Ketek is the brand name

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

FDA black boxes antibiotic Ketek  -  Feb 13, 2007
Xinhua,13 (Xinhuanet) -- The US Food and Drug Administration on Monday removed from the label of the antibiotic Ketek its approval for use in the treatment of

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 Curbs Use of Ketek  -  Feb 12, 2007
WebMD12, 2007 -- Federal regulators Monday narrowed the approved uses of the controversial antibiotic Ketek, and said they will add new safety warnings for the

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 Announces Label and Indication Changes for the Antibiotic Ketek  -  Feb 12, 2007
DG NewsKetek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity (acquired outside of hospitals or long-term

Serious warning placed on antibiotic Ketek  -  Feb 12, 2007
News-Medical.net,The FDA say the controversial drug Ketek was too risky to treat those diseases and although it will remain on the market to treat pneumonia,

FDA limits use of Ketek  -  Feb 12, 2007
Washington Times,The FDA said the antibiotic, Ketek, would remain on the market but that its label will bear a new, stern warning. The agency said it and manufacturer

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

UPDATE 3-US limits use of risky Sanofi antibiotic Ketek  -  Feb 12, 2007
ReutersPA: Quote, Profile, Research) antibiotic Ketek should no longer be used to treat sinusitis and bronchitis, US officials warned on Monday,

UPDATE 3-US limits use of risky Sanofi antibiotic Ketek  -  Feb 12, 2007
ReutersPA: Quote, Profile , Research) antibiotic Ketek should no longer be used to treat sinusitis and bronchitis, US officials warned on Monday,

FDA Revises Use and Labeling Of Antibiotic Ketek  -  Feb 12, 2007
All Headline NewsRockville, MD (AHN) - The Food and Drug Administration (FDA) announced Monday it has issued revised usage and labeling of the antibiotic drug Ketek (generic

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

FDA tightens labeling, indications for Ketek  -  Feb 12, 2007
CNNWASHINGTON (CNN) -- The Food and Drug Administration on Monday announced labeling changes for the antibiotic Ketek, stripping it of two previously approved

FDA limits use of risky Sanofi antibiotic Ketek  -  Feb 12, 2007
Reuters.uk,WASHINGTON (Reuters) - US regulators warned on Monday that Sanofi-Aventis SA's antibiotic Ketek should no longer be used to treat patients with sinusitis

UPDATE 1-US limits use of risky Sanofi antibiotic Ketek  -  Feb 12, 2007
ReutersPA: Quote, Profile , Research) antibiotic Ketek should no longer be used to treat patients with sinusitis and bronchitis, saying the controversial drug

UPDATE 1-US limits use of risky Sanofi antibiotic Ketek  -  Feb 12, 2007
ReutersPA: Quote, Profile, Research) antibiotic Ketek should no longer be used to treat patients with sinusitis and bronchitis, saying the controversial drug

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).

FDA restricts use of antibiotic Ketek  -  Feb 13, 2007
Cleveland Plain Dealer,The Food and Drug Administration said the antibiotic, Ketek, would remain on the market but that its label will bear a new, strong warning.

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