Almost 2% of all prescriptions filled in the United States are for drugs that never got approval from the US Food and Drug Administration (FDA).  Fourteen of these unapproved drugs are for narcotic painkillers that the FDA says must go or their manufacturers face stiff penalties for selling them.

The drugs in question include a highly concentrated liquid morphine and others are fast acting morphine, hydromorphone, and oxycodone tablets sold as generic medications.  Some of them bypassed the FDA approval process but others were on the market before the FDA approval process began.

While announcing the 90-day deadline to cease manufacture and distribution of these 14 drugs, the FDA said there are plenty of legal versions of comparable painkillers that met FDA approval standards and they will remain on the market with no consequence to their manufacturers or to the consumers who rely on them.

On March 31, the FDA posted the names of these unapproved narcotics on its website and sent letters to the nine companies that manufacture them.  Those companies include:

• Boehringer Ingelheim Roxane, Inc. (Columbus, Ohio)
• Cody Laboratories, Inc. (Cody, Wyoming)
• Glenmark Pharmaceuticals, Inc. (Mahwah, New Jersey)
• Lannett Company, Inc. (Philadelphia, Pennsylvania)
• Lehigh Valley Technologies, Inc. (Allentown, Pennsylvania)
• Mallinckrodt, Inc., Pharmaceuticals Group (St. Louis, Missouri)
• Physicians Total Care, Inc., (Tulsa, Oklahoma)
• Roxane Laboratories, Inc. (Columbus, Ohio)
• Xanodyne Pharmaceutical Inc. (Newport, Kentucky).

All prescription drugs, including narcotic-class painkillers, come with the risk for side effects that can sometimes be quite serious.  The FDA approval process allows for the manufacturer to identify these risks and notify physicians, pharmacists, and patients that these risks exist.  When the approval process is skirted, there is no way to know what side effects to expect, how pure the medications are, and how well, if at all, they actually work.

For more information, visit http://www.fda.gov/cder/drug/unapproved_drugs/narcoticsQA.htm