07/23/2008- LegalView announced its newly revamped Ketek information portal, which will provide details of the antibiotic’s alleged risks. The potential ketek side effects already identified have included liver damage and liver failure. More>>>
03/11/2008 - Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach today announced, after a national search, the appointment of Janet Woodcock, M.D., as director of the agency's Center for Drug Evaluation and Research (CDER). More>>>
03/10/2008 - The FDA is going to put acting drug-center head Janet Woodcock in the post permanently, people with knowledge of the matter told the WSJ. More>>>
03/09/2008 - It now appears that the FDA Chief Andrew von Eschenbach, M.D. has committed perjury before Congress. Unlike Roger Clemens, who also seems to be putting his foot in his mouth before Congress, von Eschenbach´s actions appeared to have allowed unnecessary deaths to Americans –hardly the mission of the FDA. More>>>
03/07/2008 - HHS Secretary Mike Leavitt has gone part of the way toward avoiding a possible contempt of Congress charge from the House of Representatives over his reluctance to comply with a subpoena for documents related to the FDA’s approval of sanofi-aventis’ antibiotic Ketek. More>>>
03/01/2008 - Health Secretary Mike Leavitt agreed to show U.S. Food and Drug Administration documents to lawmakers in an effort to avert a threatened contempt citation. More>>>
02/29/2008 - A Republican congressman yesterday threatened to cite the secretary of health and human services and President Bush for contempt of Congress for not responding to a subpoena related to FDA testimony last year. More>>>
02/20/2008 - Rep. Bart Stupak argued for years that the U.S. Food and Drug Administration wasn't doing a good job protecting Americans from unsafe drugs.
His focus on the FDA has a personal dimension. In 2000, his 17-year-old son, who was using the acne medication Accutane, committed suicide. Mr. Stupak personally investigated whether the drug could be tied to psychiatric side effects. More>>>
02/15/2008 - Plaintiffs in New Jersey and six other states who claim the antibiotic Ketek caused liver disease are getting a booster shot from a congressional inquiry into the clinical trials that led to FDA approval. More>>>
02/14/2008 - The FDA, Aventis, a contract research organization and an institutional review board (IRB) all failed to report or investigate fraud committed in a clinical trial of Aventis’ antibiotic Ketek, a House subcommittee charged. More>>>
02/13/2008 - The latest instalment in the US Congress’ investigation into the handling of data regarding the controversial antibiotic Ketek has put pressure on the drug’s maker, Sanofi-Aventis and seen government officials and drug regulators stand accused of contempt. More>>>
02/13/2008 - The Bush administration has declined to comply with a congressional subpoena for documents related to Sanofi-Aventis' antibiotic Ketek. More>>>
02/12/2008 - Just when you think it’s all Vytorin all the time in Congress, they change things up a bit. Michigan Democrats John Dingell and Bart Stupak took a Vytorin break today to focus on possible problems in an early safety study of the Sanofi-Aventis antibiotic Ketek. More>>>
01/31/2008 - The House Energy and Commerce Committee’s investigation into sanofi-aventis’ controversial antibiotic Ketek gained steam as the panel voted on subpoenas covering individuals and numerous agency documents. More>>>
01/29/2008 - Frustrated House Democrats will try to subpoena several Food and Drug Administration officials Tuesday as part of an investigation into whether FDA criminal investigators sought to prosecute a drug company in connection with a flawed drug that killed several people. More>>>
11/22/2007 - The Food and Drug Administration is acting like a watchdog not a lapdog says outgoing chief executive of Wyeth Bob Essner and it's no fair. More>>>
11/14/2007 - Growing attention from the U.S. Congress and others is weighing on Food and Drug Administration staff who review medical products, a top FDA official said on Tuesday. More>>>
10/29/2007 - An FDA warning letter citing sanofi-aventis for failing to respond to reports of problems with a clinical trial for its antibiotic Ketek and not overseeing the trial’s investigator has rekindled a congressional investigation into the drug’s approval process. More>>>
10/26/2007 - Government investigators have said that Sanofi-Aventis ignored misconduct by doctors who helped test the high-risk antibiotic Ketek, that was later linked to several deaths. More>>>
10/25/2007 - Government investigators say drug maker Sanofi-Aventis ignored misconduct by doctors who helped test an antibiotic that was later linked to several deaths. More>>>
10/25/2007 - The US Food and Drug Administration (FDA) has slammed Sanofi-Aventis over its failure to act on known instances of fraud during clinical trials of its antibiotic Ketek (telithromycin) - accusations that the firm continues to deny. More>>>
10/25/2007 - The Food and Drug Administration said drug maker Aventis failed to act on reports of serious problems with a safety study on its antibiotic Ketek and didn't properly oversee the trial's conduct. More>>>
09/24/2007 - The antibiotic Ketek was approved by the FDA more than three years ago, ostensibly to be used for respiratory tract infections. There was no mention of side effects such as liver damage and/or liver failure. More>>>
09/05/2007 - Upon review of the available safety information, including reported cases of severe liver injury, Health Canada has determined that the benefit-risk profile for Ketek® (telithromycin) no longer supports its use for the treatment of acute exacerbation of chronic bronchitis (AECB), acute bacterial sinusitis (ABS) or tonsillitis/pharyngitis. These indications will be removed from the label.
More>>>
09/05/2007 - Sanofi-aventis Canada Inc., in consultation with Health Canada, would like to inform Canadian consumers of important new changes regarding the antibiotic KETEK(R) (telithromycin).
Do not take the antibiotic KETEK(R) to treat bronchitis, sinusitis, tonsillitis or pharyngitis (sore throat). More>>>
08/08/2007 - They're just dropping like Chinese imports -- prescription drugs that turn out to be deadly after FDA approval. More>>>
08/01/2007 - Congress is pressuring the Food and Drug Administration to improve controls and inspections over products imported from China. News reports about parasites growing in contact lens solution and stents that do more harm than good have reminded us that medical devices can also be dangerous. Fear about avian flu has added to concerns about vaccines. And, in the wake of the drug safety debacles involving the pain medication Vioxx, the antibiotic Ketek, and the diabetes drug Avandia, changes are finally coming to the FDA. More>>>
07/17/2007 - For some reason, the US Food and Drug Administration (FDA) felt that the benefits of using Ketek outweighed the risks, even though those risks include liver failure and possible death. More>>>
04/19/2007 - 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 agents that circumvent antibiotic resistance. Since then, Ketek has been linked to dozens of cases of severe liver injury, been the subject of a series of increasingly urgent safety warnings, and sparked two Congressional investigations of the FDA's acceptance of fraudulent safety data and inappropriate trial methods when it reviewed the drug for approval. More >>>
02/12/2007 - The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients.
More >>>
03/30/2007 -PARIS (AFX) - Sanofi-Aventis said today that the European Medicines Agency (EMEA) has updated its indications for use of the group's Ketek antibiotic, prohibiting its use for patients with a rare auto-immune disease and giving a 'strengthened warning' of other side effects for all patients. More >>>
If you or a loved one have experienced liver damage, liver failure, or Stevens Johnson Syndrome as a result of Ketek side effects contact the Ketek attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and Ketek attorney are standing by to answer any questions you may have regarding Ketek side effects, a possible Ketek class action lawsuit, or any other type of Ketek litigation.
Ennis & Ennis, P.A. is a national law firm specializing in mass tort law with offices in Washington D.C. and throughout Florida. |