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.

The 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.