Attorney General Richard Blumenthal filed a lawsuit in federal court to force the agency to act on his four-year-old Citizen’s Petition seeking stronger warnings on Purdue Pharma’s notorious painkiller. In a statement, he charges that “continued inaction by the FDA on OxyContin warnings…could be devastating because…abuse of prescription drugs such as OxyContin has become the greatest drug threat in the Northeast region.” This is the lawsuit.

Blumenthal filed a Citizen’s Petition in January 2004 following an investigation the previous year into Purdue Pharma. Despite info on the package insert that the FDA recommends only 12-hour dosing, Blumenthal found Purdue Pharma had strong evidence showing shorter dosing is “rife with hazard” and approximately 20 percent of all OxyContin scripts were written for dosing intervals of eight hours or less.

“The FDA has irresponsibly and illegally ignored the clear need for warnings about OxyContin prescription practices that promote abuse and addiction,” Blumenthal said. “These ongoing practices produce, in effect, an extra dose a day. After four years of proven dosing dangers and Purdue Pharma criminal convictions, the FDA seems in denial. The agency has failed to approve or even deny our four-year-old petition seeking strengthened warnings. We now need to resort to a court order to force the FDA to take action to warn and protect patients.

“The FDA is disregarding dangers of adverse reactions and side effects, as well as abuse and addiction, by failing to require stronger black box warnings or issue a safety alert or public health advisory. The FDA has a legal and moral responsibility to ensure that providers and patients fully understand the potential dangers of improperly prescribing OxyContin. Inaction by the FDA is completely inexplicable and unacceptable when public health and safety are clearly at risk.”

Purdue Pharma’s internal documents confirm that many physicians, particularly family practice and general practitioners, didn’t understand OxyContin’s controlled release delivery system and accordingly were prescribing the drug inappropriately, according to Blumenthal.

As one company document cautioned sales representatives, “look especially hard at FP/GP percentages (of off-label prescribing) they are the worst offenders, and therefore require the most education on Oxy’s dosing.” FP is family practitioner and GP is general practitioner.

On Jan. 23, 2004, Blumenthal petitioned the FDA to require that Purdue Pharma:

• Strengthen OxyContin’s black box warning to expressly reinforce the FDA approved dosing regimen and to add specific information regarding the potential dangers associated with an off-label dosing schedule;

• Issue a “Dear Healthcare Professional” letter to inform physicians of controlled substances about the potential risks of prescribing OxyContin at dosing intervals that are shorter than the FDA-approved 12-hour dosing schedule.

In addition, or as an alternative, Blumenthal requested that the FDA disseminate warnings concerning the OxyContin dosing issues through a Safety Alert, Public Health Advisory, Talk Paper or Urgent Notice.