Combination pain drugs like Vicodin from Abbott Laboratories ($ABT) are a pain for the Drug Enforcement Administration because they are easy to get and often abused.
The DEA has again asked the FDA to consider moving those and other hydrocodone-combination painkillers from class III to class II drugs. That would mean patients with a prescription would have to see a doctor for a refill, which should perhaps dampen their abuse. The FDA will discuss that at a meeting in the fall, reports Bloomberg. The DEA sought a reclassification in 2004 and 2009. Because of their position in the middle of the 5-level rating system used by FDA, the combination drugs, which also include some cough suppressants, are more easily obtained than pure hydrocodone drugs, Bloomberg says.
The last action the FDA took on the combo drugs was in January but it had to do with the amount of acetaminophen--the active ingredient in Tylenol--allowed in each combo pill. That is because acetaminophen can cause liver damage--and worse--when taken to excess. Some patients don't realize that their pain pills contain the same ingredient as Tylenol, the agency says. Drugmakers get three years either to reformulate their products to limit acetaminophen content in combo drugs to 325 mg per pill, less than half the current number, and include more explicit labeling, or to just quit making them.
The FDA has been mulling the subject over since 1999 and in October FDA advisers on the subject will meet to again weigh benefits and risks, Bloomberg says. That is after the anticipated approved of the FDA user fee reauthorization legislation, which could decide the issue for the FDA. The Senate version of the FDA user fee reauthorization legislation includes language that would require the FDA to reclassify the combo drugs, but the House version does not. A joint committee will work out the final details to be voted on.
- read the Bloomberg story