Ketek

Ketek: How did Ketek get approved and into the marketplace even though its efficacy was questioned every step of the way by many experts and every study is plagued by fraud and negligence?

Wed, 25 Apr 2007 09:49:28 -0700

Ketek: How is it possible that Ketek got approved? Before it was put into the marketplace its efficacy was questioned over and over again. Experts pointed out that the studies were plagued by fraud and negligence!

The FDA wais far from perfect when it came to Ketek.

Everything that could go wrong with Ketek. Yet, by large brush strokes of ineptitude and deceit, Ketek was approved and marketed for three indications.

Ketek Drug Maker Continues Discussion with FDA

Thu, 11 Jan 2007 07:56:46 -0700

Sanofi-Aventis, the drug maker, said yesterday that it planned additional discussions with the Food and Drug Administration after an advisory panel to the agency said the company should not be allowed to continue marketing the antibiotic Ketek.

Ketek: More safety warnings will affect sales

Wed, 13 Dec 2006 07:59:39 -0700

The antibiotic Ketek is likely to face more safety warnings. Sanofi-Aventis’ stock for the sales of Ketek will most likely be hurt in the United States and Europe. (New Ratings)

FDA seeks outside review of Ketek antibiotic on December 14 and 15

Tue, 12 Dec 2006 08:08:50 -0700

The antibiotic Ketek, is under scrutiny amid reports of liver failure in a dozen patients. Ketek, approved in 2004, is also the subject of a Senate Finance Committee investigation because of the FDA's handling of the approval and of possibly faulty data.

Ketek Labeling to Include Strong Liver Warning

Mon, 20 Nov 2006 10:44:10 -0700

The FDA and Sanofi-Aventis, the makers of Ketek, have announced that Ketek’s labeling will now include a strong warning about serious and potentially fatal Ketek liver side effects and other serious injuries. While developing serious Ketek side effects is rare, dozens of people have been seriously injured because of this medication. (Source)

US to ask if Sanofi antibiotic Ketek should still be sold

Mon, 20 Nov 2006 10:42:55 -0700

U.S. health officials said they plan to ask outside advisers in December 2006 if the antibiotic Ketek manufactured by Sanofi-Aventis should stay on the market after a dozen reports of liver failure. (Source)

FDA Has Bad Report Card on Drug Safety

Wed, 01 Nov 2006 09:49:36 -0700

An independent study of five experts says the FDA does not have the authority to pull dangerous drugs unilaterally, force changes in drug labels, or sanction drug companies that skimp on safety monitoring.
The independent study recently published its critique in the Archives of Internal Medicine. The study also contended that the FDA lacks the money and structure to insulate itself from the influence of the pharmaceutical industry. The FDA is aware of these problems and as done very little to fix them. (Washington Post)

Health Canada Issues New Warning about Ketek Antibiotic

Fri, 27 Oct 2006 11:34:39 -0700

Ketek is under fire once again, this time due to a new warning of dangerous side effects issued by Health Canada.

Telithromycin users have been shown to be susceptible to severe, perhaps life-threatening liver damage. Ketek consumers have been urged to be aware of symptoms including fatigue, jaundice, dark urine, and loss of appetite.

Health Canada recommended that patients suffering from myasthenia gravis, a chronic autoimmune condition characterized by varying degrees of weakness in skeletal (voluntary) muscles, find alternatives to Ketek.

The FDA rejected Ketek in 2001, citing risks including liver damage and blurred vision.

Live problems experienced by Ketek users

Mon, 16 Oct 2006 06:19:33 -0700

Some patients have experienced liver problems during or following treatment with Ketek. Rare cases of severe liver injury have been reported and have resulted in death. In myasthenia gravis patients, reports have also included life-threatening breathing trouble and death

FDA did not request enough valid data on Ketek

Sun, 15 Oct 2006 06:17:53 -0700

The FDA requested more information so the drug maker hired Pharmaceutical Product Development to conduct a study known as 3014. The FDA approved Ketek knowing that some of the clinical trials involved in study 3014 were fraudulent.

Aproval of Ketek was a mistake

Sat, 14 Oct 2006 06:18:53 -0700

Ketek was finally approved in April 2004 for the adult treatment of acute bacteria infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. Ketek has been linked to extremely serious adverse reactions.

Ketek Contraindication Recommended

Fri, 29 Sep 2006 11:43:02 -0700

Europe Medical News —The Committee for Medical Products for Human Use met in mid September to reference the pros and cons of various pharmaceutical drugs. The Committee voted to add a contraindication to Ketek (telithromycin) and Levviax (telithromycin), from Aventis Pharma S.A., saying that for patients with severely impaired renal and/or liver functions the two medicinal products should not be administered concomitantly with strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole. Ketek has been on the market since July 9, 2001 and is used for bacterial respiratory infections.

Liver damage and liver disease symptoms

Sat, 16 Sep 2006 11:24:49 -0700

While most liver damage and liver disease is caused by cirrhosis and hepatitis, many pharmaceutical drugs are now the cause of liver damage. Ketek, an antibiotic used for bacterial infections are one of the drugs that cause liver damage, liver failure, and death. Symptoms of liver disease include nausea and vomiting, loss of appetite, weight loss, jaundice, extreme itching sensation, vomiting blood, dark urine, shortness of breath, lack of blood clotting, and mental confusion. When liver failure occurs, a liver transplant is necessary. (Ketek)

FDA information on Ketek

Thu, 07 Sep 2006 08:04:34 -0700

There are many resources available from the FDA tjhat discuss the side effects of Ketek, including the most recent labeling as of June 29, 2006, patient information as of July 21, 2006, Q & A as of July 5, 2006, and FDA news as of June 29, 2006. (FDA)

Some in FDA think Ketek a Mistake

Wed, 06 Sep 2006 08:05:19 -0700

How discomforting it must be for those prescribed Ketek to learn that FDA internal emails reveal that scientists and researchers believe that the antibiotic Ketek should not have been approved for the pharmaceutical marketplace. These emails show that there was no real proof if the drug actually worked. Even if Ketek works better than other drugs of this genre, the data suggests that Ketek was more toxic than antibiotics. (Corp Watch)