| Ketek: True Stories and Interviews |
"Ketek Almost Killed Me"
 Two years ago, Teresa Virgin was prescribed Ketek for a simple sinus infection. It was almost her death sentence. "I went through 65 days of hell, including three hospital visits and my teenage kids thought they were losing their Mom," says Teresa. [ READ MORE KETEK ]
Ketek can Kill
 The last thing Cheryl Trotter could possibly imagine after taking one Ketek pill would be complete kidney failure. "One day I was fine, the next day on my deathbed. I went from a slight cough and next thing I know, I'm in the hospital with renal failure - I couldn't believe it," she says. [ READ MORE KETEK ]
"Ketek Caused My Father's Death"
"My dad had a bout of bronchitis and was prescribed this antibiotic in May, 2005. Within 24 hours he got so dizzy that he had to hang up on a long-distance phone call to my brother." Mary Kane's father was dead within a week She's convinced Ketek is to blame. [ READ MORE KETEK ]
A Near Miss with Ketek
 Chad's intuition most likely served him well. After his violent reaction to a single Ketek pill, he called his doctor's office but they didn't return his call. Then he 'googled' Ketek and found out that two deaths were directly linked to this over-prescribed antibiotic. [ READ MORE KETEK ]
I Want To Tell Everyone: Don't Take Ketek
 John Mortimer was prescribed Ketek for a simple sinus infection. Luckily he only took it for five days. "I want to tell this to the public: do not take Ketek! I was in hospital with serious side effects - if I took it for any longer, I probably wouldn't be telling you what happened to me," he says. [ READ MORE KETEK ]
Taking Ketek a Second Time might be the Last Time
 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 enzymes. "The hepatologist (liver specialist) said he was positive Ketek was to blame and I have the medical records," says Hammond. [ READ MORE KETEK ]
Ketek: Sales Reps Push Profits over Safety
Andy Johnson is 35 years old, doesn't drink and has no family history of liver problems - there was no reason not to have a healthy liver. Until he took Ketek. [ READ MORE KETEK ]
Ketek Liver Warnings Too Late
 Trisha will think twice before taking another antibiotic. Her doctor prescribed Ketek for a sinus infection and Trisha believes she is "lucky to be alive," after she only took two pills. "When I woke up I was feeling really sick and I had double vision - I couldn't see anything on the television." [ READ MORE KETEK ]
The Pain of Ketek
Last September, Rosalie Lentz had a nasty headache related to a sinus infection and her doctor prescribed Ketek. Nobody at that time had any idea that this drug might almost cause her death. [ READ MORE KETEK ]
Why is Ketek still being Prescribed?
 My doctor prescribed Ketek a few months ago for a sinus infection - I had a lot of congestion. She gave me a few samples of 400mg pills and I took a total of four pills over two days. The evening of the second day I started to get stomach cramps. [ READ MORE KETEK ]
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| History of Ketek |
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Ketek® (Telithromycin) is the first ketolide antibiotic to enter clinical use. It is used to treat mild to moderate respiratory infections.
Telithromycin was approved by the European Commission in July 2001 and gained FDA approval April 1 , 2004.
There was some scandal when a major contributing Physician was sent to prison for submitting false data to the main safety study done to prove the safety of the drug. For some reason the FDA approved Ketek anyway.
The first alarms went up in 2006 when cases of liver damage and failure started turning up in Ketek patients. The FDA removed it's approval for most uses in 2007.
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| Ketek Warnings |
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Call your doctor right away if you experience nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Other possible side effects of Ketek include severe liver damage and vision changes such as blurred or double vision.
You are warned to contact your doctor if you experience any of the above symptoms after taking Ketek.
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| Ketek Criticisms |
Ketek sparks Criticisms of FDA Approval Process
Critics of the Food and Drug Administration approval process frequently point to Ketek as evidence that the FDA is not properly protecting the safety of American consumers. The process by which Ketek was approved was filled with false data, illegal activity, and omitted information yet still the drug was approved. [ READ MORE KETEK ]
Ketek Approval Still Haunting FDA Part I
The approval of Ketek still haunts the U.S. Food and Drug Administration (FDA), three years after it was first introduced on the market and six years after Sanofi-Aventis first applied for approval to market the antibiotic. Ketek is one of three drugs, the other two being Vioxx and Avandia, that came under scrutiny after being approved because of the serious side effects experienced by patients who took the drug. [ READ MORE KETEK ]
Ketek Approval Still Haunting FDA Part II
The doctor involved in the Ketek trial has been charged for her actions and sentenced to 57 months in prison after pleading guilty to one count of mail fraud. She enrolled 400 patients into the study, more than any other doctor. At the rate Sanofi-Aventis offered per patient, $400, that was a lot of extra income. Her illegal actions allegedly included forging consent forms and faking data. [ READ MORE KETEK ]
Ketek Linked to Liver Damage, Approval Process Flawed
 An antibiotic linked to severe liver damage was twice turned down by the U.S. Food and Drug Administration (FDA) before it was finally approved, and has since undergone several label updates as reports of side effects roll in, and concern mounts. [ READ MORE KETEK ]
Serious Side Effects Associated with Ketek
Ketek, a drug designed to clear up sinus infections has been linked to serious adverse reactions including liver disease and death. Although its use has now been limited by the U.S. Food and Drug Administration (FDA), Ketek is still available to some patients who may not realize how serious the risks associated with Ketek are. [ READ MORE KETEK ]
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| Ketek Side Effects |
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Ketek is in a class of ketolide antibiotics used to treat bacterial infections such as pneumonia, chronic bronchitis, and acute bacterial sinusitis.
Ketek (telithromycin) has been linked to liver damage in dozens of cases, some of which resulted in liver failure and death. The manufacturer, Sanofi-Aventis, has stopped a marketing plan for the drug. Health authorities are investigating the use of the antibiotic after numerous cases of liver damage and several deaths.
Known side effects of Ketek include nausea, dizziness, blurred or double vision, drowsiness, jaundice and liver damage.
If you develop symptoms yourself, or you have lost a loved one who was taking this drug, you should consider contacting a Ketek lawyer who will review your case at no charge.
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| Ketek Casualties |
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A 26-year-old man died two weeks after taking Ketek for five days. A 51-year-old woman required a new liver after taking Ketek, and a 46-year-old man developed drug-induced hepatitis after he stopped taking Ketek.
As US authorities are conducting an investigation of the antibiotic, medical professionals are warning patients taking Ketek to talk to their doctor about any side effects and any prior history of liver disease or kidney dysfunction.
Contact your doctor immediately if you develop jaundice (yellowing of eyes or skin) or get blurry vision or any other health problem while taking Ketek, These can be symptoms of liver damage and should not be ignored. If untreated, liver damage can lead to total liver failure, requiring a liver transplant or dialysis.
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| Ketek Controversy |
FDA Orders Changes to Ketek but Leaves It on the Market
The U.S. Food and Drug Administration (FDA) is making changes to the labeling of Ketek following pressure from numerous organizations regarding the drugs' safety. The organization has announced that Ketek will now come with a black box warning to alert consumers to the potential for serious side effects associated with taking the drug. [ READ MORE KETEK ]
FDA Hounded Over Ketek Scandal
The new drug application for the antibiotic, Ketek, was rejected twice, in 2001 and 2003, before FDA management approved the drug on April 1, 2004, based on fraudulent studies, and over the objections of the agency's own scientists. [ READ MORE KETEK ]
Ketek Fraud Investigation Derails Confirmation of New FDA Commissioner
 When the Democrats won control of Congress, Senator Charles Grassley may have lost the chairmanship of the Senate Finance Committee, but the current acting FDA commissioner had better not get too settled in because the Senator is apparently not ready to throw in the towel in the on-going battle with him. [ READ MORE KETEK ]
Ketek: A Timeline of Lies
Despite information indicating that using Ketek (telithromycin) carried a serious risk of liver disease and other problems, the US Food and Drug Administration (FDA) approved the antibiotic for sale in April, 2004. [ READ MORE KETEK ]
FDA Still Dodging Bullets Over Ketek
In recent months Senator Charles Grassley (R-IA) has been like a dog with a bone when it came to investigating why FDA officials approved the antibiotic Ketek, despite its knowledge that the main pre-approval study on the drug was riddled with fraud. [ READ MORE KETEK ]
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| Ketek Press Releases |
SEP-24-07: 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. Since that time, scandals and treachery—mainly involving study 3014--seem to have held no bounds regarding the drug, its manufacturer and the FDA. [ READ MORE KETEK ]
 SEP-11-07: Recently prescribed for sinus infections - from bronchitis to bacterial sinusitis to pneumonia - Ketek is now only prescribed for the latter, and it also comes with added warnings. This changes came about only because of several reported deaths and multiple cases of severe side effects including kidney and liver failure. [ READ MORE KETEK ]
SEP-06-07: Echoing recent changes by the US FDA, Health Canada is removing the approval of Ketek for treatment of all infections except community- acquired pneumonia of mild to moderate severity. Ketek's label will include a stronger warning about hepatotoxicity, visual disturbances and loss of consciousness [ READ MORE KETEK ]
AUG-08-07: Earlier this year federal regulators limited the approved uses for Ketek and requested new safety warnings for the drug. However, given the serious side effects associated with Ketek, including liver damage, compared with the minor illnesses it treats, some medical professionals are left wondering if Ketek should be left on the market at all. [ READ
MORE KETEK ]
 AUG-25-07: Ketek has been linked to liver damage in dozens of cases, some of which resulted in liver failure and death. Earlier this year federal regulators limited the approved uses for Ketek and requested new safety warnings for the drug. [ READ MORE KETEK ]
JUL-17-07: 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. [ READ MORE KETEK ]
 JUL-02-07: At least one person has had a different, life-threatening reaction to Ketek; now patients are investigating the possibility of filing lawsuits against the manufacturer Sanofi-Aventis for serious side effects like toxic epidermal necrolysis (TEN).
[ READ MORE KETEK ]
JUL-26-06: At least one U.S. drug safety official wants Ketek taken off the shelves. The New York Times has reported that Dr. David Graham, a U.S. drug safety official with the Food and Drug Administration believes that the FDA's 2004 approval of the drug Ketek -- manufactured by Sanofi-Aventis for the treatment of acute upper respiratory tract diseases -- was a mistake.
[ READ MORE KETEK ]
JUN-14-06: The FDA has continued to cite a fraudulent study in information released to the public about the safety of the antibiotic Ketek. On January 20, 2006, the agency issued a Public Health Announcement, in response to an article in the Annals of Internal Medicine, where researchers reported three cases of severe liver problems in patients taking Ketek.
[ READ MORE KETEK ]
JAN-20-06: An antibiotic approved by the FDA in 2004 is now under investigation by the agency after reports of severe liver damage in some patients taking the drug.
[ READ MORE KETEK ]
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| Ketek In the News |
SEP-02-07: The FDA investigated Dr. Carl R. Lang for how he conducted trials regarding Ketek although it never punished him for alleged problems with his trials. Among the problems were that clinic staff enrolled in the study and that he enrolled 251 patients when the approved limit was 50. [ TIMES: KETEK]
AUG-23-07: Ketek is a perfect example of how lax the FDA's drug approval process is. The FDA has confirmed 53 cases of liver failure related to the drug, including five deaths. [ NEWS INFERNO: KETEK]
MAY-31-07: Since it was approved by the FDA Ketek has been linked to 53 cases of liver failure, five deaths, and two liver transplants. Both the FDA and Sanofi-Aventis knew about problems with Ketek's clinical studies but neither took steps to prevent it from being approved. [ TIMES: KETEK]
MAY-27-07: The maker of Ketek knowingly included false data in its submission to the FDA. The false data included falsified test results, staff and family members of doctors enrolled in the study, and edited medical records. [ TIMES: KETEK]
MAY-21-07: One man who took Ketek reported feeling as though he had "catastrophic illness." His symptoms included chills, dizziness, pain in legs, and fever. He is planning on joining many others who filed lawsuits against the makers of Ketek. [ NBC 5: KETEK]
MAY-07-07: A Canadian woman spent four weeks in a burn unit after a suspected reaction to Ketek. The woman took Ketek for a sinus infection, but developed toxic epidermal necrolysis, a condition in which people shed the outer layer of their skin. [ TIMES COLONIST: KETEK]
MAY-01-07: Following concerns about the FDA's approval of Ketek the Senate is considering legislation that would significantly change government oversight of the drug industry. [ STAR-LEDGER: KETEK]
APR-19-07: The FDA's approval of Ketek was a process marked by fraudulent data, use of uncontrolled safety reports, and reliance on improperly conducted trials. Despite this, the FDA stood by its decision to approve Ketek. Seven months after Ketek was put on the market, the first death from liver failure associated with Ketek was reported. The FDA still has not properly addressed the events surround its approval of Ketek. [ NEW ENGLAND JOURNAL OF MEDICINE: KETEK]
APR-09-07: The FDA has learned that it cannot ignore Senator Charles Grassley's requests for information about the antibiotic Ketek. Grassley noted that Ketek was approved for the marketplace using falsified data. [ IOWA POLITICS: KETEK]
MAR-30-07: EMEA prohibits use of Ketek for patients with a rare auto-immune disease and gives strengthened warning of other side effects for all patients. [ FORBES: KETEK]
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