Widely prescribed neuropathic pain drugs gabapentin & pregabalin to be under pharmacovigilance scrutiny
Indian drug regulators have sought pharmacovigilance (PV) for neuropathic pain drugs gabapentin and pregabalin due to cardiovascular related adverse event citing a study by American medical journal Cardiovascular Diabetology.
PV is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine or vaccine related problem, according to the World Health Organization (WHO).
Neuropathic pain is caused by damage or injury to the nerves that transfer information between the brain and spinal cord from the skin, muscles and other parts of the body. The pain is usually described as a burning sensation and affected areas are often sensitive to the touch.
“These drugs are widely prescribed drugs with a market size of Rs. 3,000 crore in India alone and therefore it becomes very evident to bring these drugs under pharmacovigilance to assess their safety and efficacy in the Indian population,” according to Rajasthan Assistant Drug Controller Manoj Tongra.
According to the US study, in patients with diabetic neuropathy who were prescribed gabapentin and pregabalin, there is an increased risk for heart failure, myocardial infarction, peripheral vascular disease, stroke, deep venous thrombosis, and pulmonary embolism with long-term use. The findings of the study suggest that increased risk for adverse cardiovascular events, along with other side effects, the efficacy of pain control and the degree of tolerance of the patient, should be considered when prescribing gabapentin and pregabalin long-term in patients with diabetic neuropathy.
Gabapentin and pregabalin are commonly prescribed medications to treat pain in patients with diabetic neuropathy.
This study was meant to examine the association between gabapentin use, pregabalin use and several adverse cardiovascular events. This retrospective cohort study used propensity score matching within patient electronic health records (EHRs) from a multicenter database with 106 million patients from 69 health care organizations in the US. The study population comprised 210,064 patients who had a diagnosis of diabetic neuropathy and were prescribed diabetic neuropathy medications in their EHRs.
“The exposure cohort comprised patients who were prescribed gabapentin or pregabalin to treat diabetic neuropathy. The comparison cohort comprised patients who were not prescribed either gabapentin or pregabalin but were prescribed other drugs to treat diabetic neuropathy. The outcomes of interest were myocardial infarcts, strokes, heart failure, peripheral vascular disease, and venous thromboembolic events. Both gabapentin and pregabalin were associated with increased risk of 5-year adverse cardiovascular events compared with the comparison group,” the US study revealed.
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