What actions were taken by the FDA after Ketek was linked to severe liver complications?
By: LawInfo
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.
Search LawInfo's Ketek Resources
Additional Ketek FAQs
-
Q:
What is Ketek?
A: Ketek (telithromycin) is a prescription antibiotic drug made by Aventis Pharmaceuticals indicated for the treatment of pneumonia, throat and sinus infections and … More -
Q:
Are there side effects associated with Ketek use?
A: Side effects associated with the use of Ketek include nausea, headache, dizziness, vomiting, and diarrhea. Ketek may cause problems with vision, particularly when … More -
Q:
Has the FDA issued any warnings about Ketek?
A: 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" … More -
Q:
Has the FDA issued a Ketek Recall?
A: While the FDA did not recommended a Ketek recall, there was an investigation to determine whether Ketek should remain on the market. More -
Q:
What is pharmaceutical product liability?
A: 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 … More -
Q:
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?
A: 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 … More -
Q:
Does my doctor need to inform me of all options when it comes to prescription drugs and medical devices?
A: 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. More -
Q:
Can I file a lawsuit if I have been injured as the result of taking Ketek?
A: 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 … More -
Q:
What is a black box warning?
A: A black box warning, also referred to as a boxed warning, is the most urgent warning mandated by the FDA. It is used to alert consumers of the adverse risks … More
