Is pregabalin a controlled substance

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Pregabalin as a Controlled Substance

Introduction to Pregabalin

Pregabalin is a medication primarily used to treat neuropathic pain, fibromyalgia, and as an adjunctive therapy for partial-onset seizures. It is known for its efficacy in managing conditions such as diabetic peripheral neuropathy and postherpetic neuralgia 9. However, due to its potential for misuse and abuse, various regulatory bodies have reclassified pregabalin as a controlled substance.

Reclassification in the UK

In the UK, pregabalin has been reclassified as a class C controlled substance. This decision was driven by a significant increase in deaths associated with its misuse. The reclassification aims to curb the growing misuse and addiction problems linked to pregabalin 127. The British Medical Association (BMA) has also advocated for this reclassification to address the widespread issues of misuse and addiction 3.

Regulatory Changes and Impact

The reclassification of pregabalin in the UK, effective from April 2019, has introduced stricter controls on its prescribing, dispensing, and collection. These changes are expected to reduce the drug's misuse by making it more challenging to obtain 7. Similar measures have been implemented in Saudi Arabia, where the Saudi Food and Drug Authority added pregabalin to the list of controlled substances in December 2017 to minimize its abuse and misuse 5.

Classification in the United States

In the United States, pregabalin is classified as a Schedule V controlled substance under the Controlled Substances Act. This classification subjects pregabalin to regulatory controls and criminal sanctions related to its manufacture, distribution, dispensing, importation, and exportation 6. The classification reflects the drug's potential for abuse and dependence, although it is considered to have a lower potential for abuse compared to drugs in Schedules I-IV 9.

Conclusion

Pregabalin's reclassification as a controlled substance in various countries underscores the growing concerns about its misuse and associated risks. These regulatory changes aim to mitigate the potential for abuse while ensuring that patients who genuinely need the medication can still access it under stricter controls. The global trend towards tighter regulation highlights the importance of balancing the therapeutic benefits of pregabalin with the need to prevent its misuse and protect public health.

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Most relevant research papers on this topic

Pregabalin and gabapentin become controlled drugs to cut deaths from misuse

Pregabalin and gabapentin will become controlled drugs in the UK from next April to reduce deaths from their misuse, the government said.

Rigorous Journal

2018·

34citations

·S. Mayor

British Medical Journal

UK government to reclassify pregabalin and gabapentin after rise in deaths

Pregabalin and gabapentin could be reclassified as class C controlled substances after an increase in deaths linked to their use, following safety warnings and concerns about misuse and addiction.

Very Rigorous Journal

2017·

35citations

·Gareth Iacobucci

British Medical Journal

BMA annual meeting: Pregabalin must be made a controlled drug, BMA says

Pregabalin should be made a controlled drug to tackle widespread misuse and addiction, the BMA has said.

Very Rigorous Journal

2017·

4citations

·Tom Moberly

British Medical Journal

Misuse of gabapentin and pregabalin may be underestimated

Misuse of gabapentin and pregabalin may be underestimated, supporting the government's decision to reclassify them to class C controlled substances.

Very Rigorous Journal

2017·

10citations

·L. Naharet al.

British Medical Journal

The impact of regulatory restrictions on pregabalin use in Saudi Arabia: An interrupted time series analysis

The addition of pregabalin to the controlled substances list in Saudi Arabia has significantly reduced its use compared to other drugs for treating neuropathic pain.

Observational StudyRigorous Journal

2022·

4citations

·Turki A. Althunianet al.

Pharmacoepidemiology and Drug Safety

Schedules of controlled substances: placement of pregabalin into schedule V. Final rule.

Pregabalin, its salts, and products containing pregabalin are now subject to Schedule V regulations and penalties, requiring manufacturers, distributors, dispensaries, importers, and exporters to follow these regulations.

2005·

43citations

Federal register

Pregabalin and gabapentin: what impact will reclassification have on doctors and patients?

Pregabalin and gabapentin reclassification as class C controlled substances in the UK is expected to lead to a decline in their use, as prescribing, dispensing, and collecting them becomes more onerous for doctors, pharmacists, and patients.

Rigorous Journal

2019·

17citations

·I. Torjesen

BMJ

Subjective, psychomotor, and physiological effects of pregabalin alone and in combination with oxycodone in healthy volunteers

Pregabalin may increase subjective effects and decrease respiration rate when combined with oxycodone, but does not increase drug liking or desire to take the drug again.

RCT

2012·

42citations

·J. Zacnyet al.

Pharmacology Biochemistry and Behavior

Pregabalin: an antiepileptic agent useful for neuropathic pain.

Pregabalin may be beneficial for treating neuropathic pain or partial-onset seizures in patients who do not respond to conventional treatments or cannot tolerate their adverse effects.

Highly Cited

2007·

90citations

·M. Blommelet al.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists

Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin?

Pregabalin shows promise in relieving neuropathic pain and improving sleep, but its role in the elderly's analgesic armamentarium remains unclear due to high frequency of central nervous system adverse events.

Systematic ReviewHighly Cited

2005·

170citations

·D. Guay

The American journal of geriatric pharmacotherapy

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