Family physicians are well aware of the health risks associated with prescribing opioids for pain relief. As these risks have become more evident, the AAFP and other health care organizations have joined forces and made significant strides in combating the opioid misuse epidemic. Thanks to these efforts, the United States has seen a substantial drop(www.cdc.gov) in the number of prescriptions for opioid medications since use of these drugs peaked in 2012.
But although the number of opioid prescriptions is on the decline, the number of Americans living with chronic pain is not. The result? An uptick in prescriptions for nonopioid medications such as gabapentin, which is frequently prescribed(www.ncbi.nlm.nih.gov) off-label to treat certain types of acute or chronic pain, including migraine headaches and fibromyalgia.
Moreover, even though drugs such as gabapentin (and a similar medication, baclofen) have historically been considered safer than opioids for managing certain types of pain, a recent study(www.tandfonline.com) in Clinical Toxicology challenges that assumption. The study found that exposures to both drugs have increased considerably since 2013 and have been associated with increases in suicide attempts, hospital admissions and other negative health outcomes.
"We are seeing a worrying increase in harmful exposures to gabapentin and baclofen in U.S. adults over recent years, which may be an unintended consequence of the move away from opioid prescriptions for pain management," said Kimberly Reynolds, M.S., D.N.P., the study's lead author, in a press release.(newsroom.taylorandfrancisgroup.com)
- As the number of opioid prescriptions has dropped, prescriptions for certain nonopioid drugs for pain management have increased.
- A new study indicates that exposures to two such nonopioid medications -- gabapentin and baclofen -- have increased considerably since 2013.
- Family physicians are strongly encouraged to assess the potential risks and benefits of using these drugs for pain management before prescribing them to patients.
"Building a better understanding of the risks carried by these nonopioid medications is necessary so that providers and patients can make better informed decisions about their role in pain management -- and could also lead to the introduction of new public health measures."
Study Details and Findings
The study was a retrospective review of data collected by poison control centers across the United States and reported to the National Poison Data System.
For the review, the researchers examined all cases of exposures to gabapentin and baclofen in patients 18 and older. For gabapentin, they analyzed data from 2013 to 2017; for baclofen, they analyzed data from 2014 to 2017.
The researchers found concerning trends in the use of both drugs.
For example, they identified an increase in overall exposures to gabapentin of 72.3% during the period examined, with exposures rising in every state. This represented more than 74,000 exposures, either to gabapentin alone or in conjunction with other substances such as sedatives or antidepressants. Of these, nearly 52,000 exposures were categorized as intentional (i.e., deliberate misuse or abuse or attempted suicide), with 81% identified as attempted suicides. Isolated exposures -- that is, those involving only gabapentin -- increased by more than two-thirds.
Similarly, overall baclofen exposures increased by 36.2% during the period examined, yielding a tally of more than 15,000 exposures either to baclofen alone or in combination with other substances. Nearly 11,000 of these exposures were determined to be intentional, of which slightly more than three-quarters were attempted suicides. In total, exposures rose in 43 states. Isolated exposures increased 35% during this period.
Outcomes following exposure to either drug included hospitalizations and deaths, with 16.7% of isolated gabapentin exposures and 52.2% of isolated baclofen exposures resulting in admission to a health care facility. In all, 37 deaths were attributed to isolated exposures; 19 of these were linked to gabapentin use.
The researchers suggested that the increased number of exposures to gabapentin and baclofen -- which occurred despite an overall decline in exposure events reported to poison control centers from 2013-2017 -- could have resulted from efforts to shift patients with acute or chronic pain away from prescription opioids and toward other medications that may provide similar benefits.
FDA Issues Warning on Gabapentinoid Use
On Dec. 19, the FDA issued a drug safety communication(www.fda.gov) warning health care professionals of the risk of severe breathing problems in patients with respiratory risk factors who use gabapentinoids (i.e., gabapentin and pregabalin). These risk factors include use of opioids or other drugs that depress the central nervous system, as well as the presence of conditions such as COPD that reduce lung function. The warning also applies to elderly patients, said the agency, which is requiring updates to the prescribing information for these drugs that reflect these risks.
"Reports of gabapentinoid abuse alone, and with opioids, have emerged and there are serious consequences of this co-use, including respiratory depression and increased risk of opioid overdose death," said(www.fda.gov) Douglas Throckmorton, M.D., deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research. "Our goal in issuing today's new safety labeling change requirements is to ensure health care professionals and the public understand the risks associated with gabapentinoids."
Based on available data, the agency recommends that patients receive gabapentinoids at the lowest possible dose and that they be monitored closely for symptoms of respiratory depression and sedation when gabapentenoids are coprescribed with an opioid or other CNS depressants such as benzodiazepines.
"While the risks of opioids have been widely publicized, medication alternatives to opioids also carry risks that need to be better understood, described and disseminated to that providers and patients can make decisions regarding the role of these medications in their pain management based upon an evidence-informed risk-benefit analysis," they wrote.
Furthermore, they contended, "As poison center data do not represent the totality of cases in the United States, the steep upward trends in reported exposures reflect a much larger problem than the raw numbers would suggest."
Family Physician Expert's Perspective
Robert "Chuck" Rich, M.D., of Bladenboro, N.C., who represents the Academy on the AMA Task Force to Reduce Opioid Abuse, told AAFP News the study findings should serve as a reminder for FPs to be cautious when using gabapentin and baclofen in managing a patient's pain.
"While beneficial as adjunctive medications for the treatment of pain in selected syndromes, both of these medications are associated with an increased risk of misuse and/or abuse, particularly in individuals with a history of a substance use disorder," Rich said. "Use of these medications should be undertaken only after an assessment of the risk versus benefit for the treatment of pain in each patient."
Rich provided more specific suggestions for gabapentin. Use of that drug, he said, "should probably be reserved for pain secondary to neuropathic pain syndromes such as postherpetic neuralgia, with cautious usage in other pain syndromes such as fibromyalgia, chronic back pain, migraine headaches or other forms of chronic pain."
Finally, Rich likened the current rise in gabapentin and baclofen use to the explosion in opioid use a decade ago.
"As a family physician with 30-plus years' experience treating patients, including both acute and chronic pain patients, the discussion of and recognition of the dangers associated with these medications reminds me of the concerns regarding prescription opioids," he said. "While the two medications discussed here do not carry the same degree of risk of opioid pain relievers, the emphasis that has been applied to use of these medications as alternatives to opioids and the marketing associated with these medications, particularly for gabapentin, reminds me of the same processes that led to inappropriate use of prescription opioids.
"As we have learned from the opioid crisis and now the developing concerns associated with these two medications, the treatment of pain is an issue that requires careful consideration of each patient, with a full understanding of the risks versus benefits for each modality used and the obtainment of proper consent from those patients for use of these medications," he added.
Related AAFP News Coverage
AMA Opioid Task Force Outlines Road Map to End Epidemic
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