Ketek Indications Reviewed in Other Countries

Washington, DCThe United States is not the only country to limit the approved uses of Ketek in the wake of deaths related to the drug. Health Canada has followed in the footsteps of the Food and Drug Administration (FDA) and removed the approval of Ketek for chronic bronchitis, tonsillitis/pharyngitis and bacterial sinusitis. Ketek will only be indicated to treat community-acquired pneumonia of mild to moderate severity.

Patients who are prescribed Ketek for any of the recently removed conditions should ask their doctor about using other antibiotics. Ketek was in the Canadian news in May after a woman had a severe reaction to Ketek known as epidermal necrolysis. Patients with epidermal necrolysis shed the outer protective layer of their skin. The woman was found with water blisters over her face and back, peeling skin, and no eyelashes. She was treated in a burn unit, where she stayed for four weeks.

Also echoing recent changes by the FDA, Health Canada is including information about contraindications in patients with myasthenia gravis or with a history of hepatitis, jaundice, or other liver injury. Finally, Ketek's label will include a stronger warning about hepatotoxicity, visual disturbances and loss of consciousness. Health Canada has received 105 suspected adverse drug reaction reports regarding Ketek since it was approved for use. Those reports included a woman who died from a heart attack after taking Ketek for 10 days.

Ketek's safety was called into question after it was linked to liver failure in a dozen patients and four deaths. At an advisory panel meeting, panel members were asked to discuss whether or not the benefits of Ketek outweighed the risks. FDA staff members were allowed to present a negative view of Ketek at the meeting.

Among the negatives associated with Ketek were the risk of liver failure and the increased incidence of blurry vision, which was reported in one out of every 100 people. Former FDA staffer Dr. David Ross noted that the FDA knew about a fatal outcome in a patient who developed Ketek-related liver failure but did nothing. Furthermore, Ross noted, the FDA did nothing about reports of fraud in Ketek trials.

In an interview with CanWest News Service, Ross said, "I've run into one infectious disease physician after another who keeps saying, why do we need this drug? What exactly is the hole that it's filling?"

Symptoms of liver damage include nausea, dark urine, jaundice, lack of appetite, stomach pain and low fever. Patients who develop any of these symptoms while taking Ketek should seek medical attention immediately. People who are otherwise healthy are experiencing serious side effects from Ketek. Just because a person is in good health does not mean that he or she will not experience some form of liver failure when taking Ketek. Anyone taking Ketek is at an increased risk of developing serious liver problems.