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Pregabalin’s use in cancer-associated neuropathic pain is controversial;[31] though such use is common.[32] There is no evidence for its use in the prevention of migraines and gabapentin has also been found not to be useful.[33] It has been examined for the prevention of post-surgical chronic pain, but its utility for this purpose is controversial.[34][35]

Pregabalin is generally not regarded as efficacious in the treatment of acute pain.[28] 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.[34][36] Several possible mechanisms for pain improvement have been discussed.[37]

Anxiety disorders
Pregabalin is moderately effective and is safe for treatment of generalized anxiety disorder.[38] 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 SSRIs as first line treatment for obsessive–compulsive disorder and post-traumatic stress disorder.[39] It appears to have anxiolytic effects similar to benzodiazepines with less risk of dependence.[40][41]

The effects of pregabalin appear after one week of use 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.[42] 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.[42] It produces less severe cognitive and psychomotor impairment compared to benzodiazepines.[42][43]

A 2019 review found that pregabalin reduces symptoms, and was generally well tolerated.[38]

Other uses
Evidence finds little benefit and significant risk in those with chronic low back pain.[44][45] Evidence of benefit in alcohol withdrawal as well as withdrawal from certain other drugs is limited as of 2016.[46]

Adverse effects
Exposure to pregabalin is associated with weight gain, sleepiness and fatigue, dizziness, vertigo, leg swelling, disturbed vision, loss of coordination, and euphoria.[47] It has an adverse effect profile similar to other central nervous system depressants.[48] Adverse drug reactions associated with the use of pregabalin include:[49][50]

Very common (>10% of people with pregabalin): dizziness, drowsiness.
Common (1–10% of people with pregabalin): blurred vision, diplopia, increased appetite and subsequent weight gain, euphoria, confusion, vivid dreams, changes in libido (increase or decrease), irritability, ataxia, attention changes, feeling high, abnormal coordination, memory impairment, tremors, dysarthria, parasthesia, vertigo, dry mouth and constipation, vomiting and flatulence, erectile dysfunction, fatigue, peripheral edema, feeling the effects of drunkenness, abnormal walking, asthenia, nasopharyngitis, increased creatine kinase level.
Infrequent (0.1–1% of people with pregabalin): depression, lethargy, agitation, anorgasmia, hallucinations, myoclonus, hypoaesthesia, hyperaesthesia, tachycardia, excessive salivation, hypoglycaemia, sweating, flushing, rash, muscle cramp, myalgia, arthralgia, urinary incontinence, dysuria, thrombocytopenia, kidney calculus
Rare (<0.1% of people with pregabalin): neutropenia, first degree heart block, hypotension, hypertension, pancreatitis, dysphagia, oliguria, rhabdomyolysis, suicidal thoughts or behavior.[51]
Cases of recreational use, with associated adverse effects have been reported.[52]

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.[48] 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.[53]

It is unclear if it is safe for use in pregnancy with some studies showing potential harm.[54]

In December 2019, the U.S. Food and Drug Administration (FDA) warned about serious breathing issues for those taking gabapentin or pregabalin when used with CNS depressants or for those with lung problems.[55][56]

The FDA required new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids.[55] 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.[55]

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.[55]

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.[55] One trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function.[55] The other trial showed gabapentin alone increased pauses in breathing during sleep.[55] 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.[55] The FDA also reviewed several animal studies that showed pregabalin alone and pregabalin plus opioids can depress respiratory function.[55]

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.[57][58][59]

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).[60]



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