Questions and Answers for Consumers about FDA's Action Involving Unapproved Oxycodone Single-Ingredient, Immediate Release Drug Products for Oral Administration
What action is FDA taking today?
The FDA is announcing its intent to take enforcement action against companies that manufacture or distribute unapproved single-ingredient, immediate-release oral drug products containing oxycodone hydrochloride, labeled for human use.
Consumers should be aware that approved versions of these drugs will remain available.
Why is FDA taking this action?
These products have been associated with reports of medication errors causing serious adverse events. In addition, some unapproved products omit important warning information in their labeling. This action is part of FDA’s continuing effort to ensure that new drugs marketed in the United States have the required FDA approval, which means that they have been found to be safe, effective, of good quality, and appropriately labeled.
What effect will FDA’s action have on people who currently use these oxycodone products?
Consumers will continue to have access to FDA-approved oxycodone products. There are FDA-approved versions of these drug products on the market that contain the same active ingredient, strength(s), and dosage forms as the unapproved products. All of the manufacturers of the approved versions of these products have given FDA assurances that they can adequately supply the market.
Some of these products have been on the market so long, why take them off now?
Over the past century, the laws outlining the requirements for drug approval have changed. As a result of these changes in the law, many of the products that are the focus of the FDA action have been marketed without being approved under the current legal requirements. Many health care providers have been unaware of the unapproved status of these drug products and have unknowingly prescribed them because the drugs’ labeling does not disclose that they lack FDA approval. Currently, the law requires that new drugs be shown to be safe, effective, adequately labeled, and of appropriate manufacturing quality prior to being approved by FDA for marketing in the United States. In an attempt to address this issue, the FDA’s Unapproved Drugs Initiative, which began in 2006, has been systematically targeting marketed unapproved drugs and removing them from the market.
How can people tell the difference between FDA-approved and unapproved prescription products?
Health care professionals and consumers can use Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/) or the National Drug Code (NDC) Directory to determine whether a drug product is FDA-approved. Drugs@FDA contains most FDA-approved drug products. Search results from the NDC directory include a column marked “Application Number.” FDA-approved products will have an associated NDA (new drug application) or ANDA (abbreviated new drug application) number in this column.
Is it safe to use the unapproved products?
The safety of unapproved new drugs is unknown. Approved versions of single-ingredient, immediate-release oral drug products containing oxycodone have been specifically reviewed by FDA for safety and effectiveness.
Should I keep taking my medications?
The FDA cannot give medical advice to individual patients. Patients who have concerns about their medications should speak to their health care professionals.
Which Oxycodone drugs are being marketed without approval?