If your petition doesn't succeed, go to court. That's what Connecticut Attorney General Richard Blumenthal has done: He's sued the FDA to force the agency to act on his bid for tougher warnings on the painkiller OxyContin, so-called "hillbilly heroin" that is widely abused. At issue, Blumenthal says, is that drug labeling recommends dosing every 12 hours, but 20 percent of all OxyContin scrips were written for dosing every eight hours or less. Drugmaker Purdue Pharma's internal documents show that many docs have been prescribing the drug inappropriately, the AG alleges.
Blumenthal's 2004 petition asked the agency to require Purdue Pharma to strengthen the med's black-box warning and issue a "Dear Healthcare Professional" letter about the shorter-term dosing risks. "The FDA has irresponsibly and illegally ignored the clear need for warnings about OxyContin prescription practices," the AG alleges. "Prescription narcotic abuse of drugs like OxyContin has become the biggest drug threat in the Northeast."
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