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LYRICA® CR, CV (pregabalin extended-release) Drug Abuse and Dependence

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

LYRICA CR contains pregabalin, a Schedule V controlled substance.

9.2 Abuse

In a study of recreational users (N=15) of sedative/hypnotic drugs, including alcohol, LYRICA (450 mg, single dose) received subjective ratings of "good drug effect," "high" and "liking" to a degree that was similar to diazepam (30 mg, single dose). In controlled clinical studies in over 5500 patients, 4% of LYRICA-treated patients and 1% of placebo-treated patients overall reported euphoria as an adverse reaction, though in some patient populations studied, this reporting rate was higher and ranged from 1 to 12%.

Carefully evaluate all patients treated with LYRICA CR for history of drug abuse and observe them for signs of LYRICA CR misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).

9.3 Dependence

In clinical studies, following abrupt or rapid discontinuation of LYRICA CR, some patients reported symptoms including insomnia, nausea, headache diarrhea, or anxiety [see Warnings and Precautions (5.6)], consistent with physical dependence. In the postmarketing experience with LYRICA, in addition to these reported symptoms there have also been reported cases of hyperhidrosis.

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