Side Effect Ridden Antibiotic Acquires “Black Box” Warning
Following a year long investigation into the side effects of the controversial antibiotic Ketek, warnings on the drug have been increased by the FDA. The drug’s use for treatment of sinusitis and bronchitis has also now been banned.
“FDA has determined that the balance of benefits and risks for Ketek do not support continued approval of Ketek for these generally nonserious and often self-limited illnesses,” said Dr. John Jenkins, director of the agency’s Office of New Drugs.
The drug will still be permitted for the treatment of pneumonia Read my article on Overcoming a Life-Threatening Infection With The Help of Home Remedies.
After 5 Ketek patients died, a Senate Finance Committee investigated whether faulty data and fraud were a part of the FDA’s approval process for the drug.
Ketek will now carry a “black box” warning against its use by patients with the neuromuscular disorder myasthenia gravis under the FDA’s new rules. Because of it’s thick black border which makes it stand out, the “black box warning” is the strongest warning that the can be put on a drug by the FDA. Any further concern requires a ban on the drug.
Prior to the black box warning, Ketek already carried a bold warning about possible damage to the liver. Other possible side effects, including blurred vision and loss of consciousness have now been added to list.
At the head of the Senate’s investigation was Sen. Charles Grassley of Iowa. The Senator has been less than satisfied with FDA’s approval of the drug but did express satisfaction with the new rules. “When the spotlight was turned on the questionable way in which Ketek got approved … the FDA was held accountable,” he said.
Big deal. A black box warning? This stuff puts people in black boxes. It should be thrown off the face of the earth, no less banned.
This is nothing more than a measure the FDA has taken to avoid banning the drug and taking money away from Big Pharma. It’s like a judge giving a murderer probation instead of imprisonment because the convict somehow earns money for him.
Folks, don’t be fooled into believing that prescription med’s are the only way to treat pneumonia. Click here to learn about natural remedies to treat pneumonia.
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Posted: February 17th, 2007 under FDA.
