FDA cracks down on unapproved narcotic painkillers
March 31, 2009
The Associated Press reports that the government has ordered 14 unapproved narcotic painkillers off the market, prescription versions of potent morphine, hydromorphone and oxycodone. The Food and Drug Administration told nine manufacturers to quit distributing the drugs within 90 days. The FDA insisted that there are plenty of legal versions of the painkillers being sold for patients who need relief. The move is part of the FDA''s years-long attempt to weed out thousands of prescription drugs that sell despite never being formally approved by the health regulatory agency. Many entered the market decades ago, before federal law required such approval. The FDA estimates that unapproved drugs account for 2 percent of all prescriptions filled. The FDA targeted unapproved versions of high-concentrate liquid morphine sulfate and unapproved immediate-release tablets containing morphine sulfate, hydromorphone and oxycodone. Most of them are generic. To help consumers tell if they have an approved or unapproved version, the FDA posted both lists on its Web site
http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#narcotics. Even FDA-approved versions of these painkillers pose a risk of serious side effects, but the unapproved products add an extra problem: Regulators haven''t checked that those versions work as well and are as pure as their approved competitors. Companies that don''t heed the FDA''s deadline could face big penalties.