Ketek Side Effect Lawsuit

Details: Parent Category: Lawsuit News Alerts; Category: Side Effects Lawsuit

Ketek Side Effect Lawsuit

Ketek Side Effect Lawsuits

side-effects-lawsuit According to the FDA, antibiotic drug Ketek increases the potential risk of life-threatening liver damage in patients. The drug, brand name of telithromycin and manufactured by Sanofi-Aventis, is prescribed as a treatment for moderate to severe respiratory infections, including pneumonia, sinusitis, and bronchitis. Ketek has been linked to sudden and fatal liver damage, drug-induced hepatitis, gastrointestinal side effects, and mild to moderate neurological disorders. It also causes false positive reading of patients tested for cocaine. In the past seven years, the FDA adverse reaction reporting system has received at least 20 reports of death caused by hepatic side effects of Ketek. The federal regulator has also added

a black box warning to the drug informing patients about the risk of liver failure caused by its side effects. Many experts believe that given the safety concerns, the FDA should not have approved the drug for sale in the country because the risks posed by Ketek outweigh its benefits.

FDA Warnings and Complaints

The FDA allowed French pharma Sanofi-Aventis to market Ketek in 2004. However, rare but fatal Ketek side effects, including liver damage, were reported in January 2006. The FDA received three liver failure reports, one ending in death, second requiring liver transplant, and the third resulting in drug-induced hepatitis.

In April 2006, a report by the FDA Epidemiology and Surveillance wing highlighted at least 12 cases of acute liver failure linked to Ketek. The report found that four of the 12 patients died as a result of the severe side effects, while one patient had to undergo a liver transplant. The federal regulator also identified additional 23 cases where patients suffered from serious liver injury after taking the drug.

In December 2006, two FDA advisory panels called for restricted use of Ketek. The committees urged the regulator to suspend the use of the drug for the treatment of certain respiratory problems, including acute sinusitis and acute chronic bronchitis caused by bacterial infections.

In February 2007, the FDA updated labeling of Ketek. It passed an order asking the manufacturer to add a black box warning to the drug informing consumers and doctors about the possible risk of liver damage. It also banned the drug for the treatment of bacterial exacerbations of chronic bronchitis and sinusitis citing the findings demonstrating that risks outweighed benefits. The FDA also prohibited prescription of Ketek to patients suffering from myasthenia gravis, a musculoskeletal disorder resulting in muscle weakness.

In April 2008, an independent analysis of the FDA data revealed that Ketek side effects had resulted in 134 cases of liver damage and 18 deaths across the United States. Many consumer groups and independent reviews put the numbers at much higher.

A research report published in 2010 highlighted that Ketek side effects also put consumers at the increased risk of visual disturbances. Live failure, and aggravates myasthenia gravis muscular disorder. According to the report, the drug adversely affects cholinergic receptors responsible for proper functioning of the neuromuscular junction. It also damages vagus nerve vital for liver functioning and ciliary ganglion of the eye.

Ketek Side Effects

Ketek has been linked to serious side effects, including jaundice, loss of consciousness, blurred vision, focusing problems, and colon inflammation, among others. These side effects sometimes make it difficult for patients to drive safely, operate machinery, or carry out any other potentially hazardous task. Some patients have even complained to have temporarily lost their consciousness after administration of the drug. Some patients experience inflammation of the large intestine, change in sense of smell, and muscle cramps.

Liver Damage

Ketek has been linked to serious liver damage in many patients. In rare cases, this causes liver failure leading to death. Patients treated with the drug therapy experience low fever, nausea, loss of appetite, stomach pain, jaundice, clay-colored stools, and dark urine. This might also have some allergic reactions in some patients, including swelling of the face, throat, lips, and tongue and breathing difficulty.

Liver damage symptoms include unexplained itching, itchy skin, loss of appetite, increased tiredness, vomiting, nausea, right upper belly pain, irregular heartbeats, fainting, weakness, flu-like symptoms, muscle pain, unusually dark urine, jaundice, diarrhea, and difficulty swallowing. In many cases, Ketek was linked to severe and fatal hepatotoxicity, including hepatic necrosis, fulminant hepatitis, and hepatic failure.

Musculoskeletal Side Effects

Ketek musculoskeletal side effects include muscle cramps and exacerbation of arthralgia, myasthenia gravis, and myalgia. It worsens conditions of patients already suffering from muscle weakness disorder.

Nervous System Side Effects

Post-marketing reviews have documented mild to moderate neurological side effects of Ketek. The drug causes loss of focus and consciousness, vagal syndrome, pins and needles sensations, and dizziness in patients treated with it. Ketek side effects also include headache, somnolence, paresthesia, anxiety, and loss of taste.

Hypersensitive Side Effects:

Patients taking Ketek are likely to suffer from hypersensitivity reactions, including anaphylaxis and angioedema. The FDA has received reports of allergic reactions and facial edema during post-marketing reviews.

Gastrointestinal Side Effects

Ketek causes gastrointestinal side effects, such as diarrhea, nausea, abdominal pain, anorexia, gastrointestinal upset, and loose stools. Post-marketing reviews have also discovered pancreatitis, pseudomembranous colitis, constipation, oral fungus infection, and stomatitis associated with Ketek side effects.

Other Ketek Side Effects

Ocular side effects include blurred vision and diplopia. Females and young adults taking the drug are likely to experience more ocular disorder.

Respiratory side effects include upper respiratory infection and fatal respiratory failure in patients with muscular disorder.

Cardiovascular side effects include hypotension, bradycardia, irregular heartbeat, arrhythmia, and palpitations.

Psychiatric disorders, such as nervousness, hallucinations, and confusion.

Ketek Lawsuits

Since 2004, when the drug was approved by the FDA, more than three million patients have been prescribed Ketek in the country. In November 2007, 47 plaintiffs filed a class action Ketek lawsuit in a Illinois court claiming that the manufacturer Sanofi-Aventis had failed to warn them about the possible side effects of the drug. The plaintiffs claim that they experienced severe liver damage following the administration of Ketek. A number of Ketek drug injury lawsuits has also been awaiting trial in various courts across the United States.

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