Pregabalin Explained

Verifiedfields:verified
Watchedfields:verified
Verifiedrevid:457473985
Width:200
Width2:215
Tradename:Lyrica, others[1]
Dailymedid:Pregabalin
Pregnancy Au:D
Pregnancy Au Comment:[2] [3]
Dependency Liability:Physical

High
Psychological: Moderate

Addiction Liability:Low (but varying with dosage and route of administration)
Routes Of Administration:By mouth
Atc Prefix:N02
Atc Suffix:BF02
Legal Au:S4
Legal Au Comment:[4]
Legal Br:C1
Legal Br Comment:[5]
Legal Ca:Rx-only
Legal Nz:Rx-only
Legal Nz Comment:[6]
Legal Uk:POM
Legal Uk Comment:/ Class C[7]
Legal Us:Schedule V
Legal Eu:Rx-only
Legal Eu Comment:[8]
Legal Status:Rx-only
Bioavailability:Oral: High (≥90% rapidly absorbed; food has no significant effect on bioavailability)
Protein Bound:<1%
Metabolites:N-methylpregabalin
Onset:May occur within a week (pain)
Elimination Half-Life:4.5–7 hours[9] (mean 6.3 hours)[10]
Duration Of Action:Approx 8 to 12 hours [11]
Excretion:Kidney
Cas Number:148553-50-8
Pubchem:5486971
Drugbank:DB00230
Chemspiderid:4589156
Unii:55JG375S6M
Kegg:D02716
Chebi:64356
Chembl:1059
Synonyms:3-isobutyl GABA, (S)-3-isobutyl-γ-aminobutyric acid
Iupac Name:(3S)-3-(aminomethyl)-5-methylhexanoic acid
C:8
H:17
N:1
O:2
Smiles:CC(C)CC(CC(=O)O)CN
Stdinchi:1S/C8H17NO2/c1-6(2)3-7(5-9)4-8(10)11/h6-7H,3-5,9H2,1-2H3,(H,10,11)/t7-/m0/s1
Stdinchikey:AYXYPKUFHZROOJ-ZETCQYMHSA-N

Pregabalin, sold under the brand name Lyrica among others, is an anticonvulsant, analgesic, and anxiolytic amino acid medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless legs syndrome, opioid withdrawal, and generalized anxiety disorder (GAD).[12] [13] Pregabalin also has antiallodynic properties.[14] [15] [16] Its use in epilepsy is as an add-on therapy for partial seizures. It is a gabapentinoid medication (GABA analogue) which are drugs that are derivatives of γ-aminobutyric acid (GABA), an inhibitory neurotransmitter.[17] [18] [19] [20] Pregabalin acts by inhibiting certain calcium channels.[21] [22] When used before surgery, it reduces pain but results in greater sedation and visual disturbances.[23] It is taken by mouth.

Common side effects include headache, dizziness, sleepiness, confusion, trouble with memory, poor coordination, dry mouth, problems with vision, and weight gain. Serious side effects may include angioedema, drug misuse, and an increased suicide risk.[24] When pregabalin is taken at high doses over a long period of time, addiction may occur, but if taken at usual doses the risk is low.[25] Use during pregnancy or breastfeeding is of unclear safety.[26]

Pregabalin was approved for medical use in the United States in 2004.[24] It was developed as a successor to the related gabapentin.[27] It is available as a generic medication.[28] [29] [30] [31] [32] In 2021, it was the 73rd most commonly prescribed medication in the United States, with more than 8million prescriptions.[33] [34] In the US, pregabalin is a Schedule V controlled substance under the Controlled Substances Act of 1970,[24] which means that the drug has low abuse potential compared to substances in Schedules I-IV, however, there is still a potential for misuse.[35] Despite the low abuse potential, there have been reports of euphoria, improved happiness, excitement, calmness, and a "high" similar to marijuana with the use of pregabalin; there is a potential for developing dependence on these substances, and withdrawal symptoms may occur if the medication is abruptly discontinued.[36] [37] It is a Class C controlled substance in the UK. Therefore, pregabalin requires a prescription.[38] [39] Furthermore, the prescription must clearly set forth the dose.[40] Pregabalin has potential for misuse. It can bring about an elevated mood in users. It can also have serious side effects, particularly when used in combination with other drugs.[40] [41]

Medical uses

Seizures

For drug-resistant focal epilepsy, pregabalin is useful as an add-on therapy to other treatments.[42] Its use alone is less effective than some other seizure medications.[43] It is unclear how it compares to gabapentin for this use.[43]

Neuropathic pain

The European Federation of Neurological Societies recommends pregabalin as a first line agent for the treatment of pain associated with diabetic neuropathy, post-herpetic neuralgia, and central neuropathic pain.[44] A minority obtain substantial benefit, and a larger number obtain moderate benefit.[45] It is given equal weight as gabapentin and tricyclic antidepressants as a first-line agent, however the latter are less expensive as of 2010.[46] Pregabalin is as effective at relieving pain as duloxetine and amitriptyline. Combination treatment of pregabalin and amitriptyline or duloxetine offers additional pain relief for people whose pain is not adequately controlled with one medication, and is safe.[47] [48]

Studies have shown that higher doses of pregabalin are associated with greater efficacy.[49]

Pregabalin's use in cancer-associated neuropathic pain is controversial,[50] though such use is common.[51] It has been examined for the prevention of post-surgical chronic pain, but its utility for this purpose is controversial.[52] [53]

Pregabalin is generally not regarded as efficacious in the treatment of acute pain.[45] In trials examining the utility of pregabalin for the treatment of acute post-surgical pain, no effect on overall pain levels was observed, but people did require less morphine and had fewer opioid-related side effects.[52] [54] Several possible mechanisms for pain improvement have been discussed.[55]

Anxiety disorders

Pregabalin is effective for treatment of generalized anxiety disorder.[56] It is also effective for the short- and long-term treatment of social anxiety disorder and in reducing preoperative anxiety.[57] [58] However, there is concern regarding pregabalin's off-label use due to the lack of strong scientific evidence for its efficacy in multiple conditions and its proven side effects.[59]

The World Federation of Biological Psychiatry recommends pregabalin as one of several first line agents for the treatment of generalized anxiety disorder, but recommends other agents such as those of selective serotonin reuptake inhibitor (SSRI) class as first line treatment for obsessive–compulsive disorder and post-traumatic stress disorder (PTSD).[60] [61] For PTSD, pregabalin as complementary treatment seems to be effective.[58]

Generalized anxiety disorder

Pregabalin has anxiolytic effects similar to benzodiazepines with less risk of dependence. The effects of pregabalin appear within one week of use,[62] and are similar in effectiveness to lorazepam, alprazolam, and venlafaxine, but pregabalin has demonstrated superiority by producing more consistent therapeutic effects for psychosomatic anxiety symptoms. Long-term trials have shown continued effectiveness without the development of tolerance, and, in addition, unlike benzodiazepines, it has a beneficial effect on sleep and sleep architecture, characterized by the enhancement of slow-wave sleep. It produces less severe cognitive and psychomotor impairment compared to benzodiazepines.[63] [64]

A 2019 review found that pregabalin reduces symptoms, and was generally well tolerated.[56]

Other uses

Although pregabalin is sometimes prescribed for people with bipolar disorder there is no evidence showing that it is effective.[58] [65]

There is no evidence and significant risk in using pregabalin for sciatica and low back pain.[66] [67] [68] Evidence of benefit in alcohol withdrawal as well as withdrawal from certain other drugs is limited as of 2016.[69]

There is no evidence for its use in the prevention of migraines and gabapentin has also been found not to be useful.[70]

Adverse effects

Exposure to pregabalin is associated with weight gain, sleepiness and fatigue, dizziness, vertigo, leg swelling, disturbed vision, loss of coordination, and euphoria.[71] It has an adverse effect profile similar to other central nervous system (CNS) depressants. Even though pregabalin is a depressant and anticonvulsant it can sometimes paradoxically induce seizures, particularly in large overdoses.[72] Adverse drug reactions associated with the use of pregabalin include:[73]

Cases of recreational use, with associated adverse effects have been reported.[75]

Withdrawal symptoms

Following abrupt or rapid discontinuation of pregabalin, some people reported symptoms suggestive of physical dependence. The FDA determined that the substance dependence profile of pregabalin, as measured by a personal physical withdrawal checklist, was quantitatively less than benzodiazepines.Even people who have discontinued short term use of pregabalin have experienced withdrawal symptoms, including insomnia, headache, nausea, anxiety, diarrhea, flu like symptoms, nervousness, major depression, pain, convulsions, hyperhidrosis, and dizziness.[76]

Pregnancy

It is unclear if it is safe for use in pregnancy with some studies showing potential harm.[77]

Breathing

In December 2019, the US Food and Drug Administration (FDA) warned about serious breathing issues for those taking gabapentin or pregabalin when used with central nervous system (CNS) depressants or for those with lung problems.[78] [79]

The FDA required new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids.[78] The FDA also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.[78]

Among 49 case reports submitted to the FDA over the five-year period from 2012 to 2017, twelve people died from respiratory depression with gabapentinoids, all of whom had at least one risk factor.[78]

The FDA reviewed the results of two randomized, double-blind, placebo-controlled clinical trials in healthy people, three observational studies, and several studies in animals.[78] One trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function.[78] The other trial showed gabapentin alone increased pauses in breathing during sleep.[78] The three observational studies at one academic medical center showed a relationship between gabapentinoids given before surgery and respiratory depression occurring after different kinds of surgeries.[78] The FDA also reviewed several animal studies that showed pregabalin alone and pregabalin plus opioids can depress respiratory function.[78]

Overdose

An overdose of pregabalin usually consists of severe drowsiness, severe ataxia, blurred vision and macular detachment,[80] slurred speech, severe uncontrollable jerking motions (myoclonus), tonic clonic seizures and anxiety.[81] Despite these symptoms an overdose is not usually fatal unless mixed with another CNS depressant. Several people with kidney failure developed myoclonus while receiving pregabalin, apparently as a result of gradual accumulation of the drug. Acute overdosage may be manifested by somnolence, tachycardia, and hypertonia. Plasma, serum, or blood concentrations of pregabalin may be measured to monitor therapy or to confirm a diagnosis of poisoning in hospitalized people.[82] [83] [84]

Interactions

No interactions have been demonstrated in vivo. The manufacturer notes some potential pharmacological interactions with opioids, benzodiazepines, barbiturates, ethanol (alcohol), and other drugs that depress the central nervous system. ACE inhibitors may enhance the adverse/toxic effect of pregabalin. Pregabalin may enhance the fluid-retaining effect of certain anti-diabetic agents (thiazolidinediones).

Notes and References

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