Addicts Pregabalin Lyrica
Potential for dependence on pregabalin (Lyrica®) (from the ADR database)
Lyrica® (pregabalin) is approved for the treatment of neuropathic pain (for example in diabetes mellitus, shingles [herpes zoster] or spinal cord injuries), as an additional therapy for epilepsy patients with partial seizures and for generalized anxiety disorders (1). The active ingredient pregabalin is an analogue of gamma-aminobutyric acid (GABA), it binds to a subunit of voltage-dependent calcium channels in the CNS and modulates the release of various excitatory (exciting) neurotransmitters. Accordingly, drowsiness and sleepiness are among the most common adverse drug effects of pregabalin.
Lyrica® has been available in Germany since 2004 and is increasingly used, especially in the indication of neuropathic pain, although it has not been proven to be more effective than, for example, gabapentin or amitriptyline (2). In 2009, 45.7 million DDD were prescribed; this corresponds to an increase of around 22 percent compared to the previous year (3). Lyrica® ranks 12th among the top-selling patent-protected pharmaceuticals in Germany, with sales of around 220 million euros in 2009.
The AkdÄ was informed by a resident neurologist and psychiatrist about the case of a 39-year-old patient (AkdÄ, case no. 153347) who was treated with pregabalin for a generalized anxiety disorder. Multiple attempts by the patient to obtain prescriptions and the admission to take up to 3000 mg of the drug daily (recommended maximum daily dose 600 mg) suggest a dependency. The reporting doctor reported that he was aware of other cases of addiction to pregabalin through colleagues.
Pharmacodynamically, due to the GABA-ergic properties of pregabalin, a development of dependence is conceivable. As the most important sedating and relaxing neurotransmitter, GABA triggers suitable psychological reactions, and numerous GABA-ergic substances, such as benzodiazepines, barbiturates or alcohol, are potentially addictive.
Another case report of addiction to pregabalin was recently published by German authors (4). The affected patient had a history of heroin addiction and a friend recommended pregabalin for its euphoric effects. In addition to pregabalin (up to 7500 mg per day), he consumed cannabis and alcohol. In a withdrawal attempt that he carried out himself, there were pronounced vegetative symptoms; an inpatient withdrawal failed.
In June of this year, employees of the Swedish Medicines Agency published 16 spontaneous reports indicating a potential for addiction and abuse to pregabalin (5). In the global database of spontaneous reports at the World Health Organization, a corresponding signal for pregabalin could be detected retrospectively as early as mid-2005 through a newly developed analysis method of case reports with the help of indicators for a potential for dependence (6). The database of the German spontaneous reporting system currently contains around 1200 reports of adverse drug reactions from pregabalin, including other cases of drug addiction and abuse in addition to the case described above.
This year, the indications of the potential for abuse of pregabalin were included under the warnings in the information for healthcare professionals (1). Although the risk may be small, patients should be made aware of this before starting treatment. Particularly in the case of a history of addictive illnesses, attention should be paid to signs of dependency development or abuse, such as an increase in the dose taken.
Please inform the AkdÄ of all observed side effects (including suspected cases). You can use the report sheet for this, which is printed regularly in the Deutsches Ärzteblatt or is available on the AkdÄ website. It is also possible to report a suspected ADR directly online via www.akdae.de.
- Pfizer Pharma GmbH: Information for professionals "Lyrica® hard capsules". Status: August 2010.
- National Association of Statutory Health Insurance Physicians, Drugs Commission of the German Medical Association: Pregabalin (Lyrica® hard capsules) active ingredient AKTUELL 02/2007. As of March 26, 2007.
- Schwabe U, Paffrath D (Ed.): Drug Ordinance Report 2010. Heidelberg: Springer Medizin Verlag, 2010.
- Grosshans M, Mutschler J, Hermann D et al .: Pregabalin abuse, dependence, and withdrawal: a case report. On J Psychiatry 2010; 167: 869.
- Schwan S, Sundstrom A, Stjernberg E et al .: A signal for an abuse liability for pregabalin results from the Swedish spontaneous adverse drug reaction reporting system. Eur J Clin Pharmacol 2010; 66: 947-53.
- Caster O, Edwards IR, Noren G0N, Lindquist M: Earlier discovery of pregabalin's dependence potential might have been possible. Eur J Clin Pharmacol 2010; Epub ahead of print.
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