Will the FDA Repeat Its “Abuse-Deterrent” Oxy Mistake With Stimulants?

    OxyContin got a makeover in 2010. That year, the Food and Drug Administration approved a new version of the opioid, made by the now-notorious Purdue Pharma, to be labeled as an “abuse-deterrent formulation” (ADF)—a first-of-its-kind designation.

    In theory, ADF OxyContin was designed to be resistant to crushing or dissolving so that people could not inhale or inject the drug. Reported OxyContin “abuse” rates seemed to drop after the prescription opioid rolled out. But a Journal of the American Medical Association study suggests that what actually occurred was a “migration,” with a high rate (70 percent of participants) transitioning to illicit heroin. The heroin supply that would soon become adulterated with fentanyl, leading to the next wave of opioid-involved overdose deaths.

    Additional harms of ADFs have been found to include a spike in hepatitis C infections. Added to that, there is inadequate evidence to support the claim that ADFs in themselves actually reduce the harms of prescription drugs, particularly opioids, concluded the Institute of Clinical and Economic Review in 2017.

    Yet the FDA has just announced that it is now interested in “explor[ing]” ADFs for prescription stimulants, such as Adderall and Ritalin. The agency has yet to propose how exactly these drugs would be designed, and is currently simply requesting public comment.

    For Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, the “abuse” of prescription stimulants is a “public health concern,” she said in a press release. However, the agency noted in its Federal Register announcement that these harms—captured through emergency department visits, drug-involved mortality and treatment center admissions—are “considerably less frequent than for prescription opioids, even after accounting for the lower prescription volume of stimulants.”

    The FDA seems to be primarily concerned with college students using prescription stimulants, given that their age range, 18 to 25, has the “highest” prevalence of use (7.4 percent). This demographic mostly uses the drugs for alertness and academic performance enhancement, the FDA’s announcement said. But the agency also notes that they use in less risky ways, with “a large majority” of students swallowing the drugs, and inhalation recorded only occasionally. Injecting, which is associated with the risk of overamping or blood-borne infection transmission, is almost never seen in this group, according to the FDA.

    What the FDA fails to recognize is how ADF stimulants might put people who use stimulants at increased risk. Although it’s unclear whether college students would switch to an illicit supply, “which represent[s] a large and growing public health concern,” as the FDA noted, some people who use methamphetamine substitute Adderall as a way to moderate and reduce harms. For one 2013 study participant, moving to Adderall was a way to mitigate the “nausea, itchiness of skin, and paranoia” she experienced when using meth.

    Adderall is considered by harm reduction expert Dr. Carl Hart, a Columbia University professor of psychiatry, to have “nearly identical effects” to meth. Yet despite the close chemical similarity between meth and Adderall, using unregulated street meth is riskier—due to uncertain dosages, modes of ingestion and potential contaminants.

    The availability of prescription Adderall and similar drugs could therefore be functioning as a “safe supply” for people who seek stimulants. This is something that could be mitigating the so-called “fourth wave” of the crisis of drug-related deaths.

    The FDA should not move toward “abuse deterrent” formulations for stimulants without strongly considering this factor.

    Photo of Adderall via Wikimedia Commons

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