Serious Side Effects Associated with Ketek

Chicago, ILKetek, 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.

One doctor only realized risks associated with Ketek use because he had two patients who were seriously harmed by the drug. One of his patients died and the other required a liver transplant.

A different patient said he went through "pure hell" after taking Ketek. Tom Manno, speaking to an NBC5 reporter, said he had chills, trouble walking, dizziness, leg pain, and fevers. "I really thought I was getting a catastrophic illness," Manno told the reporter. He was seriously ill for eight weeks before his liver started its recovery.

Liver failure may not take a long time to develop in people who take Ketek. One patient, Ramiro Obrajero Pulquero, went to his doctor with a cold and was told to take Ketek. Pulquero developed jaundice, fever, and began vomiting blood. In three weeks he had died of liver failure. According to the Annals of Internal Medicine, Pulquero had only taken Ketek for five days.

Concerns about Ketek began when researchers reported that three cases of severe liver problems, including Pulquero, occurred in patients at a North Carolina hospital. Of the three patients, one died, one required a liver transplant, and one, who developed drug-induced hepatitis, recovered after treatment with Ketek was stopped. There was no evidence that the three had liver damage before they used Ketek.

The Annals of Internal Medicine reported that surgeons removed 1.5 L of clear ascitic fluid from the abdomen of the patient who had the liver transplant at the North Carolina hospital. Additionally, the patient's liver "appeared to have large areas of necrosis."

Ketek, made by Sanofi-Aventis, was developed to treat bronchitis and sinus infections. The FDA has linked Ketek to four deaths and 53 reported cases of liver failure. Since the FDA learned of the risks, Ketek has been withdrawn for the treatment of sinus infections but is still available to patients who have a certain type of pneumonia.

Sanofi-Aventis has been criticized for the safety trials it commissioned regarding Ketek. Criticisms of Sanofi-Aventis include fraud, malpractice, and conflicts of interest.

The FDA is also under fire for the Ketek approval process. One of the doctors who participated in the Ketek safety study allegedly falsified results, a fact that FDA managers hid from the FDA panel that eventually recommended the drug. Furthermore, allegations have arisen that although the FDA knew patients died after using Ketek, the agency did not request a new warning label for the drug until newspapers started covering the stories.

Patients who take Ketek are also at risk of developing blurred vision and loss of consciousness. Patients with myasthenia gravis, a neuromuscular disease, have reported a worsening of their symptoms, including life-threatening problems breathing, when they have been treated with Ketek.

If you are taking Ketek and develop any signs of liver distress, contact a doctor immediately to discuss whether you should continue taking the drug. Signs of liver distress include loss of appetite, nausea, dark urine, pale stools, jaundice, and itching or abdominal pain. If you have taken Ketek and developed adverse side effects including liver problems, contact a lawyer to discuss your options.