Hospice Medication Update: Oxycodone Oral Solution Availability
Posted by Dr. Jim Joyner
Our hospice partners have been telling us about difficulty in obtaining oxycodone oral solution and dramatically increasing cost when available. Several of the generic manufacturers for oxycodone solution have discontinued production recently. This is in response to FDA action starting last year to remove “unapproved drugs” from the market-place. For a variety of mostly historical reasons, some drugs, mostly older products, continue to be marketed in the United States without required FDA approval. The FDA has expressed their concern that the lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern. Many of these products have been in widespread use in the United States for decades with proven track records of efficacy and safety, however, the FDA considers all of the unapproved products to be marketed illegally and has taken action to force the manufacturers to discontinue them or apply for FDA approval.
FDA sent warning letters to several suppliers of unapproved narcotic medications (including morphine, oxycodone, and hydromorphone) last year. These companies were given a specified time-frame to stop manufacturing new product, until they went through a formal process for approval of their products with FDA. Wholesale distributors were instructed to stop shipping “unapproved” product. The following manufacturers: Mallinckrodt, Lannett, and Glenmark, have stopped production of all oxycodone solutions in accordance with the unapproved drug ruling by FDA. As far as we can tell that leaves only one manufacturer (Xanodyne Pharmaceuticals) that has an “approved” oxycodone solution product on the market. They market their product as the brand name Roxicodone and it is significantly more expensive than the discontinued “unapproved products”.
More detailed information can be found on the FDA website at www.fda.gov.