In 2010, OxyContin® Tablets were reformulated with inactive ingredients intended to make the tablet more difficult to manipulate for misuse and abuse

Abuse-deterrence studies: in vitro testing

  • Compared to original OxyContin and IR oxycodone, there is an increase in the ability of OxyContin to resist crushing, breaking, and dissolution using a variety of tools and solvents
    • When subjected to an aqueous environment, OxyContin gradually forms a viscous hydrogel (i.e., a gelatinous mass) that resists passage through a needle
  • Abuse-deterrent properties do not prevent or reduce the risk of addiction1
  • Abuse of OxyContin by injection and intranasal routes, as well as by the oral route, is still possible
  • All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use
  • With parenteral abuse, the inactive ingredients in OxyContin can be expected to result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, valvular heart injury, embolism, and death. Cases of thrombotic microangiopathy (a condition characterized clinically by thrombocytopenia and microangiopathic hemolytic anemia) associated with parenteral abuse have been reported. Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV
Additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of OxyContin on the abuse liability of the drug. Accordingly, section 9.2 (titled Abuse) of the Full Prescribing Information may be updated in the future as appropriate.

Additional Important Safety Information

OxyContin contains oxycodone, a Schedule II controlled substance. As an opioid, OxyContin exposes users to the risks of addiction, abuse, and misuse. Opioid agonists are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing OxyContin. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Inform patients that the use of OxyContin, even when taken as recommended, can result in addiction, abuse and misuse, which can lead to overdose and death. Instruct patients not to share OxyContin with others and to take steps to protect OxyContin from theft or misuse.

Down arrow

Reference: 1. US Food and Drug Administration. Remarks delivered before FDA's scientific meeting on opioids. July 10, 2017. Accessed February 21, 2018.