Ketek—What is it Good For? Absolutely Nothing!

Washington, DCWhen it comes to Ketek, the FDA has proven yet again that it is incapable of policing the drug industry. The antibiotic ketek has been linked to potentially lethal side effects, from liver failure to Stevens-Johnson Syndrome (SJS). Although several SJS ketek cases have been reported, the drug maker Sanofi Aventis is only now "discussing" whether to strengthen the existing warning about allergic reactions to include the potential for "skin events", meaning SJS.

Ketek History

Aventis first asked the FDA for market approval of Ketek in 2000 but the antibiotic was initially declined. For some inexplicable reason, it was approved for distribution in 2004, even though no new information came out in those 4 years to make it safe. In fact the only new information was a Sanofi Aventis-funded study: the drug company hired doctors (called enrollers) who submitted data from patients treated with Ketek.

The results showed that the liver failure rate with ketek was no more prominent than with other antibiotics but that wasn't true. The study was found to be seriously flawed. In fact one doctor in the clinical study was on probation for gross negligence and falsifying records and was sent to prison.

Aventis said they didn't know about the flawed study, nor did they contact the FDA when they did know it was fraudulent. So the FDA said this study was so fraudulent that it could not be approved, yet the agency went ahead and approved Ketek anyway.

In February, 2007 the FDA slapped a black box warning on Ketek for liver injury, loss of consciousness, and visual disturbances. But the drug has also been prescribed to treat simple colds and coughs, a use for which the drug was never intended, exposing many people, including children, to a very dangerous antibiotic. Ketek has never been approved for use in children in the U.S. yet it is business as usual at Sanofi Aventis.

The FDA has concluded that Ketek's benefit to patients outweighs its potential risk to the user—but try telling that to SJS ketek sufferers.

SJS Ketek Victim

Last spring, a young woman in Quebec City spent 30 days in a burn unit after suffering a severe allergic reaction to ketek. Her skin was covered in burning red blisters, then it skin peeled off—from head to thigh, even in her mouth. She developed SJS and TEN (toxic epidermal necrolysis) which is potentially lethal and is almost always caused by a reaction to a drug. She had been prescribed ketek for a sinus infection. According to Health Canada, she was found semi-conscious with swollen lips and face. Water blisters developed on her thorax, face and back and more than 50 per cent of her body was affected. Today she has "scars all over her body and face, has lost her eyelashes and has been severely affected psychologically."

SJS is extremely painful and some patients need to be put into an induced coma, sometimes for several weeks. Treatment for the woman involved extensive lubricants on her skin, "debriding" or removal of dead tissue around her eyes to prevent scarring and intravenous injections to prevent infection. "She had just had a baby, it was really hard," said Christine Hamel, a hospital pharmacist who saw the woman when she arrived in emergency. "It's just an antibiotic she took," Hamel said. "It's not like when you have cancer (treatments) you expect to have side effects because it's going to save your life. Maybe she could have been prescribed something else. It's not like it was the last choice she had."

Stevens Johnson Syndrome (SJS) And its more severe form called Toxic Epidermal Necrolysis (TEN) are life threatening serious skin disorders which can result in blindness, organ dysfunction and death. The association of SJS and TEN with Ibuprofen products like Motrin and Advil has been reported in the medical literature since the 1970's. Despite this association the manufacturers failed to warn the consumers of the risk of SJS or TEN. Not only did they fail to warn the consumers they failed to warn physicians as well. Adding insult to injury, the drug companies starting in 1995 began to sell their Ibuprofen products over the counter, without any warnings, where they could access millions of consumers.

More than six million Ketek prescriptions have been written by US doctors. Despite the FDA's belief, many experts and regulators say that Ketek's risks may not be worth the limited benefits, particularly true when it comes to the risk of SJS.

If you or someone you know has taken Ketek and developed any of the above symptoms, contact a doctor immediately. You might also want to contact a Ketek attorney.