Neurontin, Lyrica, Similar Drugs May Cause Respiratory Problems When Used With Opioids: FDA
Federal health officials have issued a new warning about the potential risk of respiratory problems with Neurontin, Lyrica and other generic forms of the nerve treatment drugs, which may occur when taken in conjunction with opioids or other prescription medications.
The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication on December 19, requiring new warnings for the prescribing information of a clas of medications known as gabapentinoids, which are used to treat seizures and nerve pain problems, including spinal cord injury, shingles, diabetes, fibromyalgia and restless leg syndrome.
The warning applies to gabapentin-based drugs, including Neurontin, Gralise and Horizant; and pregabalin-based drugs, including Lyrica and Lyrica CR.
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Learn MoreThe FDA’s decision to add the warning comes after a review of numerous reports, observational studies, human and animal trials, which found that when the drugs are used together with opioids, users may experience dangerous breathing problems that lead to hospitalization or even death.
At least 49 case reports have been received involving respiratory depression linked to gabapentinoid use over a five-year period from 2012 to 2017, including 12 deaths. All of those affected had at least one risk factor. In addition, the FDA examined the results of several studies linking gabapentinoids to respiratory depression.
Officials indicate that individuals taking Lyrica, Neurontin and other generic forms face an increased risk of respiratory depression when also taking opioids, or other drugs intended to depress the central nervous system. The drugs also may cause problems for individuals who already have other respiratory risk factors.
“These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease that reduce lung function,” the FDA warning states. “The elderly are also at higher risk.”
As a result, the FDA is ordering makers of Neurontin, Lyrica and other generic forms to add a warning on the label to warn doctors against prescribing the drugs with other medications intended to slow down the respiratory system, including opioids. A separate warning for elderly patients with decreased lung function is also being required.
In addition to the new warning, the FDA is also requiring the manufacturers to conduct clinical trials to evaluate the risk of combining these medications with opioids, with an emphasis on identifying any adverse events related to the respiratory system.
The FDA indicates both gabapentin and pregabalin prescriptions have significantly increased over the last over the last several years, all while the nation continues to battle an ever-growing opioid epidemic.
Officials indicate that between 2012 and 2016, the number of patients who were prescribed gabapentin increased from 8.3 million to 13.1 million a year, and the number of patients who filled a pregabalin prescription increased from 1.9 million to 2.1 million a year. Officials also found that during the 2016 calendar year, the number of patients that were co-prescribed gabapentin or pregabalin in conjunction with opioids increased from 14% to 19%.
The FDA is warning doctors to always start gabapentinoid prescriptions at the lowest dose and monitor patients for symptoms of confusion or disorientation, unusual dizziness or lightheadedness, extreme sleepiness or lethargy, slowed, shallow, or difficult breathing, unresponsiveness, which means a person doesn’t answer or react normally or you can’t wake them up, or bluish-colored or tinted skin, especially on the lips, fingers, and toes
Any and all adverse health consequences arising from the prescription medications should be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
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5 Comments
MarieDecember 1, 2021 at 12:25 am
I was prescribed Gabapentin for several years and began to have difficulty breathing at times to the point I had to have an inhaler. Gabapentin made my hair fall out too. I told my physician this and he said the drug didn't list that side effect...but it did. Other women I know that took the drug experienced the same hair loss issue.
TimJune 23, 2021 at 11:21 pm
Took Gabapentin for many years for Diabetic Nerve pain and Fibromyalgia. Had shoulder surgery and was prescribed Vicatin for pain. I developed major breathing issues. One morning (2019) I woke up because I was unable to breathe at all. I honestly thought that I was going to die. I rolled out of bed and into the floor, swalling pockets of air in my cheeks and finally was able to get air into my lu[Show More]Took Gabapentin for many years for Diabetic Nerve pain and Fibromyalgia. Had shoulder surgery and was prescribed Vicatin for pain. I developed major breathing issues. One morning (2019) I woke up because I was unable to breathe at all. I honestly thought that I was going to die. I rolled out of bed and into the floor, swalling pockets of air in my cheeks and finally was able to get air into my lungs. After x-rays of my chest, it was determined that one of my lungs had partially collapsed. I still have difficulties breathing and also the majority of the side effects listed on the fda site. Can a drug injury claim be filed? Tim
StacieNovember 27, 2020 at 11:14 pm
I was put on neurontin for nerve pain ended of 18 in march of 19 my behavior changed multiple falls multiple trips to hospital. Fell march 2020 broke left arm. April my daughter started to find me unresponsive on the floor. In May she said i ate a bottle of anatriptalin went to hospital back on a ventilator stomach pumped icu 2 weeks
MistyJanuary 24, 2020 at 1:22 pm
I have been on gabapentin almost five years last couple years they increase the dose I was 300 mg pills 6 in the morning 6 in the afternoon and in the evening bringing my ducks up to 6 300 mg all together daily about 2 years ago started noticing and I just did not catch my breath my sleep apnea got worse then found out that my sleep apnea was affecting me while I was awake I kept complaining about[Show More]I have been on gabapentin almost five years last couple years they increase the dose I was 300 mg pills 6 in the morning 6 in the afternoon and in the evening bringing my ducks up to 6 300 mg all together daily about 2 years ago started noticing and I just did not catch my breath my sleep apnea got worse then found out that my sleep apnea was affecting me while I was awake I kept complaining about Dr why can I not breathe also at 48 years old they found out that I had a birth defect in my diaphragm two of them I have CDH and envetraited diaphragm which causes breathing difficulties as well as but it just stopped to the point I was having sleep apnea when I was awake I had to have down my lungs and they said it was irritated they set off several pathologies and said they could not determine what it was other irritation I took myself off Gabapentin and Woolah I feel better. I also complained about this being really out of it and not being able to think and concentrate and feeling like I was intoxicated when I don't drink all of this was the Gabapentin
DarlaDecember 23, 2019 at 8:55 pm
My husband was on hospice and they thought he was dying. He was on opioid medication through Hospice, and his doctors also had him on both gabapentin and lyrica. He was on oxygen from 2013 to 2018. I was able to get him off these meds, and he no longer needed hospice and started doing better. Also, our oldest son was placed on both of these medications after a bone marrow transplant. He was also o[Show More]My husband was on hospice and they thought he was dying. He was on opioid medication through Hospice, and his doctors also had him on both gabapentin and lyrica. He was on oxygen from 2013 to 2018. I was able to get him off these meds, and he no longer needed hospice and started doing better. Also, our oldest son was placed on both of these medications after a bone marrow transplant. He was also on opioids for his back fractures. He died 6 yrs 10 months after his transplant from respiratory complications while on these medications.