Background
Spinal-cord injury (SCI) is a leading cause of neuropathic pain (NP). Current pharmaceutical treatments for NP in SCI patients are not effective. Two promising options are gabapentin (GP) and pregabalin (PB). Their predominant mechanism of action is believed to be the inhibition of calcium currents, leading in turn to reduced neurotransmitter release and attenuation of postsynaptic excitability. This could explain much of their efficacy in the treatment of both seizure disorders and pain syndromes. However, evidence for their efficacy in attenuating NP of SCI is still controversial.

Efficacy of pregabalin and gabapentin for neuropathic pain in spinal-cord injury: an evidence-based evaluation of the literature.

Gastrointestinal (GI) discomforts are among the most common side effects of antiepileptic drugs (AEDs) that might lead to discontinuation or irregular consumption of the drugs. This study was conducted to evaluate the frequency of GI side effects of different AEDs in intractable epileptic patients treated with single or multiple drugs. GI discomfort of 100 epileptic patients (aged 35–76 years) treated with one or multiple AEDs was assessed. Seventy six patients (76%) were treated with two or more AEDs, and 24 (24%) were on monotherapy. The most common prescribed drug for monotherapy was carbamazepine and the most frequent combination was phenytoin and carbamazepine. Patients were suffering from different GI side effects including heartburn (34.6%), nausea (33.7%), constipation (26%), vomiting (22.1%), diarrhea (21.2%) and dysphagia (19.2%). Nausea and vomiting were significantly higher in patients receiving monotherapy with carbamazepine and valproic acid, respectively. When phenytoin, gabapentine, or valproic acid was added to the other AEDs, the risk of the occurrence of diarrhea, dysphagia, or heartburn was significantly increased, respectively. Addition of gabapentine to the other AEDs in multiple drug therapy was accompanied with the highest frequency of GI complications. This study indicated that GI side effects, which can affect drug absorption and utilization, were common in intractable epileptic patients with long-term AEDs treatment. This may influence the efficacy of the therapy with AEDs and enhance the probability of further attacks.

Gastrointestinal adverse effects of antiepileptic drugs in intractable epileptic patients.

Valproate is an effective anti-epileptic and mood stabilizer drug, but its prescription may be complicated by the development of thrombocytopenia. The purpose of the present manuscript is to provide a critical overview about the risk of thrombocytopenia during treatment with valproate. A search of the main database sources has been conducted to identify relevant papers about the topic. In the studies with a larger sample size (> 150 subjects), thrombocytopenia occurred in 12–18% of subjects receiving treatment with valproate. Advanced age, female gender, and high doses were found to be risk factors for the development of thrombocytopenia during treatment with valproate. Future research is needed to clarify the clinical impact of the occurrence of thrombocytopenia during valproate treatment (e.g., the risk of life-threatening events such as stroke or the development of thrombocytopenia during short- versus long-term administration, or oral versus intravenous formulations).

/pdf/the-risk-of-thrombocytopenia-during-valproic-acid-therapy-a-210gpe8x71.pdf

The Risk of Thrombocytopenia During Valproic Acid Therapy: A Critical Summary of Available Clinical Data.

The gabapentinoids gabapentin and pregabalin have been related to addiction citing pharmacovigilance data, some case presentations and increasing reports mainly from methadone maintenance treatment programs or emergency medicine. Most of these reports were based on patients with another current or previous substance use disorder (SUD). According to the ICD-10 dependence criteria, physical dependence (withdrawal symptoms, tolerance) was reported most frequently alongside regular use of gabapentinoids. Far less patients showed key symptoms of behavioral dependence (craving, loss of control, or addictive behavior). 

Through a literature review, we found 2 and 13 case reports about gabapentionoid-seeking behavior or craving for gabapentin and pregabalin, respectively. Those patients without a history of another SUD, but being behaviorally dependent on gabapentinoids, deemed more appropriate to reflect the true addictive power of these drugs. We found solely 4 such cases, all referring to pregabalin and none for gabapentin. Taking into account that gabapentinoids have become widely distributed and easily obtainable via the internet or black-markets, one would expect many more of these cases, if gabapentinoids had considerable addictive power. Moreover, we are not aware of any patient who sought detoxification treatment owing to the misuse of gabapentinoids. Unlike for traditional psychoactive drugs, there is only very scarce evidence for gabapentinoids to be misused in a long-term manner and to be rewarding and reinforcing in animal experiments. Further, we assessed the hazardous potential of gabapentin and pregabalin in relation to that of traditional substances of abuse. Altogether, we support the view that gabapentinoids are quite rarely addictive in the general population. In patients with a history of SUD, however, gabapentinoids (notably pregabalin) should avoided or, if thought to be beneficial, administered with caution by using a strict prescription and therapy monitoring.

/pdf/on-the-addictive-power-of-gabapentinoids-a-mini-review-36w5bkrhfm.pdf

On the addictive power of gabapentinoids: a mini-review.

Objective To assess the association between Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN) and antiepileptics including the most recently authorized drugs. Methods In the Spanish Pharmacovigilance database, we searched for spontaneous reports of SJS or TEN associated with antiepileptic drugs and analysed: a) reporting odds ratio (ROR), b) age and gender of the patient, c) evolution, d) latency and recovery periods and e) presence or absence of other suspected drugs. Results A total of 84 reports of SJS and 80 of TEN related to 9 antiepileptic drugs were studied. Reports were mainly associated with phenytoin (SJS: 28; TEN: 43), lamotrigine (SJS: 37; TEN: 20) and carbamazepine (SJS: 14; TEN: 16). Other antiepileptic drugs involved were: valproate, phenobarbital, oxcarbazepine, levetiracetam, primidone and gabapentin. Patients were of a median age of 40 [1-87] and 57.3% of them were women. Cases related to phenytoin were more common in older men and to lamotrigine in younger women. The latency period of SJS and TEN did not exceed the first month of treatment and, in most of the analysed reports, the outcome was recovery. Conclusions Our observations support the association of SJS or TEN with phenytoin, carbamazepine, valproate or phenobarbital and enlighten the role of lamotrigine and others such as oxcarbazepine or levetiracetam.

Spontaneous reporting of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with antiepileptic drugs.

Fluoroquinolones-Induced Anaphylaxis: Analysis of an Italian Spontaneous Reporting Database

To analyse and discuss the use and the safety profile of individual antiepileptic drugs (AEDs) in Italy. The AED safety data referred to the period January 1988–June 2005 and were obtained from the database of the Italian Interregional Group of Pharmacovigilance (GIF). This database collects all spontaneous reports of suspected adverse drug reactions (ADRs) from six Italian regions which are the main contributors to the Italian spontaneous reporting system. Individual AED consumption data (defined daily dose/1,000 inhabitants per day) in the GIF area and in the whole of Italy referred to the period January 2003-June 2005 and were derived from drug sales data (Institute for Medical Statistics Health). Phenobarbital was the most frequently used AED in the GIF area (4.26 DDD/1,000 inhabitants per day) followed by carbamazepine (1.97), valproic acid (1.33) and gabapentin (1.10). AED consumption in the whole of Italy showed a similar pattern. Gabapentin was the most frequently used AED among newer AEDs. In the GIF database 37,906 reports (up to June 2005) were present; 666 of them (1.76%) were associated with at least one AED (Anatomical Therapeutic Chemical code N03A). The AED with the highest number of reports was carbamazepine (208 reports) followed by phenobarbital (98), gabapentin (80), phenytoin (56), valproic acid (55), lamotrigine (51), oxcarbazepine (43) and vigabatrin (35). Use and toxicity profile were evaluated only for AEDs associated with at least 30 reports. Skin reactions were the most frequently reported ADRs, followed by haematological, general condition, hepatic, neurological and gastrointestinal adverse reactions. Phenobarbital, lamotrigine, carbamazepine and phenytoin had the highest percentage of skin reactions (69, 67, 60 and 54%, respectively). Many haematological reactions were reported for each AED; the highest percentage was related to valproic acid (25%). Vigabatrin was associated with the highest percentage of reactions related to hearing, vision and other senses (97%). Phenytoin and valproic acid had the highest percentage of hepatic reactions (30 and 20%), whereas gabapentin of nervous system, psychiatric, gastrointestinal and urinary reactions (26, 21, 21 and 14%, respectively) and phenobarbital of musculoskeletal reactions (13%). In Italy antiepileptic drug therapy appears to be still dominated by traditional drugs. Our analysis showed a different safety profile related to each AED. Some of the drug-adverse reaction associations discussed are not included in the Italian drug leaflets or have not been reported before in the literature.

Use and safety profile of antiepileptic drugs in Italy.

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Fluoroquinolones-Induced Anaphylaxis: Analysis of an Italian Spontaneous Reporting Database

Use and safety profile of antiepileptic drugs in Italy.