❇️ gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic.
❇️ clinicians in our practice community are increasingly prescribing gabapentin and pregabalin for almost any type of pain.
❇️ Brand-name pregabalin (Lyrica) ranked 8th in invoice drug spending (i.e., spending that excludes rebates and discounts) in 2016, with sales of $4.4 billion
❇️ Neurontin (the original branded gabapentin) was approved as an antiseizure drug in 1993. During the next several years, the manufacturer (Parke-Davis, a subsidiary of Warner-Lambert, which was later acquired by Pfizer) engaged in an extensive marketing campaign to increase off-label prescribing of Neurontin for pain.
❇️ Research had suggested that the drug had analgesic properties, but postherpetic neuralgia was the only pain-related indication for which there was sufficient evidence from clinical trials to justify FDA approval.
❇️ Eventually, in 2004 (after Neurontin’s patent had expired and gabapentin had become available as a generic), the manufacturer admitted to improper off-label marketing and paid a penalty.
❇️Pregabalin, which is still available only as brand-name Lyrica, was approved for treating diabetic neuropathy and postherpetic neuralgia in 2004 and fibromyalgia in 2007. In 2012, the manufacturer paid a settlement for misleading promotion of the drug for off-label indications
❇️most recently published clinical studies of gabapentinoids for pain examined single-dose or short-course gabapentinoids for mitigating postoperative pain, an indication that isn’t relevant to general outpatient practice. Relatively few clinical trials have assessed the use of gabapentinoids in the common pain syndromes for which they are prescribed off-label — and many of those trials were uncontrolled or inadequately controlled and of short duration. ❇️Among the few well-conducted, properly controlled, double-blind studies, results have been mixed at best. In a recent rigorously conducted placebo-controlled trial, pregabalin was ineffective for patients with painful sciatica.4
❇️gabapentinoids can have nontrivial side effects. Sedation and dizziness are relatively common, and some patients experience cognitive difficulties while taking these drugs
❇️appropriate management of both acute and chronic pain involves examining how the patient’s pain is affecting activity and function and setting realistic goals that may include coping with or mitigating pain, not necessarily eliminating it. This approach requires time (which is often lacking in rushed outpatient practices), expertise in communicating about a difficult and often emotionally charged symptom, and patient access to timely follow-up and continuity of care. Writing a prescription and moving on is considerably easier and less stressful for clinicians.
Perspective from The New England Journal of Medicine — Gabapentin and Pregabalin for Pain — Is Increased Prescribing a Cause for Concern?
Posted to FB on 2019-07-07 20:55:54