Ketek Frequently Asked Questions
- What is Ketek?
- Are there side effects associated with Ketek use?
- Has the FDA issued any warnings about Ketek?
- Has the FDA issued a Ketek Recall?
- What actions were taken by the FDA after Ketek was linked to severe liver complications?
- What is pharmaceutical product liability?
- If I have been taking a drug that was not prescribed by a physician, do I still have a legal recourse for injuries suffered from these drugs?
- Does my doctor need to inform me of all options when it comes to prescription drugs and medical devices?
- Can I file a lawsuit if I have been injured as the result of taking Ketek?
Ketek (telithromycin) is a prescription antibiotic drug made by Aventis Pharmaceuticals indicated for the treatment of pneumonia, throat and sinus infections and chronic bronchitis, as well as serious or multi-drug resistant infections. Approved by the FDA in 2004, Ketek is in a class of drugs called ketolide antibiotics used to treat adults 18 years of age and older with certain respiratory (lung and sinus) infections caused by various bacteria.
Are there side effects associated with Ketek use?
Side effects associated with the use of Ketek include nausea, headache, dizziness, vomiting, and diarrhea. Ketek may cause problems with vision, particularly when looking quickly between objects close by and objects far away. Some patients have severe problems with vision that may interfere with normal activities. Ketek has also been associated with adverse side effects such as liver damage, liver cell damage, liver failure, and hepatitis.
Has the FDA issued any warnings about Ketek?
In May 2006, the FDA recommended that a black box warning be added to the Ketek label, stating that "severe, life-threatening, and in some cases fatal" liver toxicity has been reported in patients taking the drug. The recommendation came after FDA safety reviewers found that Ketek has been linked to 12 cases of liver failure, including four deaths, in the U.S. In some cases, liver damage worsened rapidly and happened after just a few doses of Ketek.
Has the FDA issued a Ketek Recall?
While this FDA advisory panel has not recommended a Ketek recall, according to a December 13, 2006 report by CBS News, there is a new Congressional probe underway to determine whether Ketek should remain on the market.
What actions were taken by the FDA after Ketek was linked to severe liver complications?
The FDA approved a labeling supplement submitted by Aventis Pharmaceuticals as a "Changes Being Effected" (CBE) supplement, which highlights the 'Warnings' section of the labeling to raise attention to the risk of liver toxicity associated with Ketek.
What is pharmaceutical product liability?
Product liability is a legal term used to describe a special duty the law imposes on all manufacturers, including pharmaceutical companies. A person injured by some hidden defect in a product while using the product for its intended purposes does not have to prove the manufacturer was negligent in order to receive financial compensation.
In fact, even with proof that the manufacturer was not negligent and could not have foreseen the product defect that caused the injury, a legal claim for compensation may still remain valid.
This rule (sometimes called "strict liability" or "absolute liability,") has more to do with social policy than with purely legal matters. The idea behind it is to avoid placing the risk of catastrophic loss on an individual consumer. The manufacturer can purchase insurance to cover such claims, increasing the price of the manufactured product to cover the cost of insurance. In this way, the risk of catastrophic loss is divided among all purchasers of the product.
If I have been taking a drug that was not prescribed by a physician, do I still have a legal recourse for injuries suffered from these drugs?
In a case where no physician prescribed the drug which caused you injury, but instead you purchased it on your own, you may still have a claim against the drug manufacturer.
Does my doctor need to inform me of all options when it comes to prescription drugs and medical devices?
You have the right to be told about all alternative courses of treatment, even if your health insurance may not cover them or you may not be able to afford them.
Can I file a lawsuit if I have been injured as the result of taking Ketek?
If you or a loved one has suffered health problems from using Ketek, such as liver damage, you may be entitled to file a personal injury or wrongful death lawsuit against those responsible for the accident.
Damages sought against negligent persons and manufacturers for producing and selling products with safety defects include general and compensatory damages for:
- Past and future physical pain and suffering, mental anguish and physical impairment
- Past and future medical, incidental and hospital expenses
- Past and future loss of earnings and earning capacity, and
- Wrongful death when the injured person was killed.
For more information about your specific legal claim, consult with a Ketek litigation attorney who is experienced in trying defective drug cases.