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According to news reports a new drug known as cethromycin, part of the ketolide drug class, will begin being marketed in Asia even though a similar medicine known as Ketek, from the same drug class, raised serious red flags among physicians and drug regulators when the antibiotic was linked to severe liver toxicity among patients leading to several fatalities.
Ketek is part of the class of drugs known as ketolide belonging to the macrolide group. The ketolide antibiotics are a new group of drugs that are used to treat respiratory infections. Ketek is currently the only known ketolide available on the market and because of severe issues with toxicity the U.S. Food and Drug Administration (FDA) have issued increased regulations for the drug.
However, manufacturer Advanced Life Sciences and marketer Wyeth have continued with production of a similar ketolide even after safety concerns with the group of drugs, especially Ketek, caused a long-delay in the approval process of any new ketolide.
Ketek (telithromycin), which was made available for market in April 2004, is manufactured by Sanofi-Aventis and is used to treat the following conditions, according to the FDA:
* community-acquired pneumonia
* multi-drug resistant Streptococcus pneumoniae
* acute bacterial sinusitis
* acute bacterial exacerbation of chronic bronchitis
What Are The Ketek Risks?
In early 2006, an issue of the Annals of Internal Medicine reported the link between Ketek and the development of life-threatening liver toxicity among patients. Soon after, the FDA issued a health advisory to physicians who were giving patients prescriptions of Ketek to watch for symptoms of liver disease, as the risk was being investigated by the FDA. Among the risks doctors as well as patients were to watch for included:
* yellowing of skin/eyes
* vision loss/blurry vision
* fainting
* abdominal cramps
In addition to developing liver damage or liver toxicity, patients are also at risk for developing pseudomembrane colitis, which is an intestine infection, as well as hosting a lengthy list of side effects such as:
* watery diarrhea
* continued diarrhea
* blood stool
* stomach cramps
* nausea
* headache
* dizziness
* vomiting
* loose stools
* skin rash
* fatigue
* pain, upper abdominal and abdominal
* dry mouth
* insomnia
* vertigo
Unfortunately the list of side effects continues, and all were found during Phase III clinical trials of the drug in which 4,780 patients were tested for the drug's side effects and treatment effectiveness.
Overcoming the Ketek Risks
While the FDA continues to investigate the approximately 12 cases of acute liver failure, four fatalities and 20 cases of liver damage among patients, the drug remains on the market. Patients continue to be exposed to the potential Ketek risks of developing liver failure and liver toxicity.
Patients consuming Ketek are encouraged to contact their general physician to discuss the potential Ketek side effects. Additionally, if a patient has suffered from the Ketek dangers they are advised to consult a legal professional, particularly an experienced pharmaceutical attorney who can provide a legal consultation as to the potential need for creating a Ketek class action. Because liver damage can gravely effect an individual's life it is important that the appropriate justice is sought and, this may result in monetary compensation for a Ketek victim.
