Gabapentin enacarbil is marketed under the brand name Horizant. Nov 24, 2014. However, pairing an opioid with any CNS depressant – a gabapentinoid, benzodiazepine, sedating antidepressant, sedating antipsychotic, antihistamine, or other product – will increase the risk of respiratory depression. Myhre et al.Observational studies suggest that patients exposed to preoperative gabapentinoids have an increased risk of postoperative respiratory depression compared to those not exposed to gabapentinoids preoperatively. Gabapentin is an anticonvulsant. Topamax Legal Stats. You must declare any conflicts of interest related to your comments and responses. Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall - Complaints of Empty Capsules. Pregabalin is marketed under the brand names Lyrica and Lyrica CR, and also as generics. Following is a list of possible … One trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function.All medicines have side effects even when used correctly as prescribed, but in general the benefits of taking a medicine outweigh these risks. We comply with the HONcode standard for trustworthy health information - Gabapentin is an anticonvulsant. A Mayo Clinic research group published a case-control study describing the relationship between preoperative gabapentin exposure and the risk of postoperative respiratory depression in more than 11,000 arthroplasty patients.Animal studies have shown that gabapentinoids can cause respiratory depression alone and in combination with opioids. Patients and caregivers should seek medical attention immediately if you or someone you are caring for experiences symptoms of respiratory problems, because these can be life-threatening. We will continue to monitor these medicines as part of our routine monitoring of all FDA-approved drugs.We are requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids. "Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase," the company advises.They are notifying distributors and customers of the recall by letter to arrange for return of the product. Special attention will be paid to the respiratory depressant effects during this abuse potential evaluation.Gabapentinoids are FDA-approved to treat a variety of conditions including partial seizures and nerve pain from spinal cord injury, shingles, and diabetes. Pregabalin is a Schedule V controlled substance, which means it has a lower potential for abuse among the drugs scheduled by the Drug Enforcement Administration (DEA), but may lead to some physical or psychological dependence.Patients and caregivers should seek medical attention immediately if you or someone you are caring for experiences symptoms of respiratory problems, because these can be life-threatening. Your personal health care professional knows you best, so always tell them about all other medicines you are taking and if you experience any side effects while taking your medicines.To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving gabapentin, pregabalin, or other medicines to the FDA MedWatch program, using the information at the bottom of the page.We reviewed several sources of data including case reports submitted to FDA or published in the medical literature, observational studies, human trials, and animal studies.Gabapentinoids are increasingly being prescribed for medical uses, and misuse and abuse of these medications are growing. Agitation is the most common withdrawal symptom and is reported by half of those experiencing withdrawal. We will continue to monitor these medicines as part of our routine monitoring of all FDA-approved drugs.We are requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids.