Popular pain drug linked to rise in overdoses, suicides
By Liam Mannix & Aisha Dow
26 November 2018 — 1:11am
It has become one of Australia’s most popular pharmaceutical drugs, seen by some GPs as a safer alternative to opioid painkillers.
But an explosion of overdoses and deaths has led to growing concern about the misuse and safety of anti-epileptic and nerve pain relief pill pregabalin, sold by Pfizer as Lyrica.
Pregabalin was first listed for government subsidy for nerve pain in 2013. Between 2013 and 2017, it contributed to 164 overdose deaths in Victoria, with the number increasing almost every year, according to coronial data. Between 2009 and 2012, that number was zero.
In NSW, there were 88 pregabalin-associated deaths between 2005 and 2016, according to a study of that state’s coronial data, with similar significant increases since 2013.
Experts now say there is mounting evidence that vulnerable people are becoming addicted to it, and it is being misused by drug users and traded on the black market.
Since it was listed on the PBS for nerve pain in 2013, subsidised prescriptions have gone from 322,078 in 2012-13 to 4.07 million scripts in 2017-18, for more than 633,000 patients. It is now one of the most-costly drugs to the Australian taxpayer.
“It was initially marketed as having a low abuse potential,” said Professor Nicholas Buckley, Professor of Clinical Pharmacology at the University of Sydney.
“But the warning signs were there almost from the beginning. It was reported to cause euphoria as a side effect.”
Packets of 20 Lyrica capsules can now be found on dark-web marketplaces advertised at about $120. The Therapeutic Goods Administration (TGA) is finalising an investigation into whether any regulatory action should be taken on the pregabalin misuse.
The Age can also reveal pregabalin has also been linked to dozens of cases where patients taking it have developed suicidal thoughts.
The TGA has recorded six suicides since 2012 where pregabalin has been implicated as a factor, including the death of a 54-year-old man in 2014, in addition to another six suicide attempts, although the TGA noted there may be no link to these adverse events and the medicine.
Lyrica’s listed side-effects note that it doubles a patient’s risk of suicidal thinking or behaviour versus a placebo. For every 530 patients treated, one additional person may experience suicidal thinking or behaviour.
Professor Chris Maher, director of the Institute for Musculoskeletal Health at the University of Sydney, was recently involved in a trial investigating whether pregabalin could reduce the intensity of the back and leg pain, sciatica.
He said he almost cancelled the trial after patients complained of developing sudden suicidal urges.
“Some of the people in the trial said to us, ‘I don’t know what this medicine is, but I’m starting to think about topping myself, and I have never had thoughts like that before’,” Professor Maher said.
Professor Maher says the drug was marketed to GPs as a safer and more effective alternative to opioids for patients with nerve pain.
Pregabalin has been used for years as a successful anti-epileptic drug. It is believed to work by blocking certain nerve signals, although its exact method of action is unknown.
In 2013, Pfizer was successful in its application to have the drug listed on the Pharmaceutical Benefits Scheme for treating neuropathic pain (nerve pain).
“The safety of our medicines is of the utmost importance to Pfizer,” a company spokesman said in a statement.
He said the product information documents for doctors and consumers “clearly indicate patients should be carefully evaluated for a history of substance abuse and observed for signs of misuse and abuse”.
“The conditions pregabalin is indicated for can be chronic and debilitating and have a significant impact on the lives of patients and their families,” the spokesman said.
“It is important to note when prescribed and administered appropriately … pregabalin is a very important treatment option for many people living with chronic neuropathic pain and epilepsy.”
However the drug, also nicknamed “bud”, “gabby” or “slows”, has been increasingly coming to the attention of paramedics and other health workers for the wrong reasons.
A new report published in the Medical Journal of Australia on Monday revealed that ambulance attendances involving pregabalin jumped more than tenfold in Victoria since 2012, with more than 1200 callouts between January 2012 and December last year.
Many of those suffering overdoses had taken pregabalin with other sedatives, including alcohol, painkillers and benzodiazepine drugs such as valium.
Penington Institute chief executive John Ryan said this combination of drugs was particularly dangerous.
“It makes a multiplier effect … slowing down people’s breathing and resulting in such inadequate oxygen that they can actually die,” he said.
Mr Ryan also warned that sudden withdrawal of the drug could be risky and people should get medical advice to taper off their use slowly.
One of the key concerns of researchers probing misuse is evidence it is getting into the hands of people who may be particularly vulnerable to addiction or misuse – with a history of depression, self-harm, suicide or drug taking meaning it may have been inappropriate to prescribe them pregabalin in the first place.
One study estimated that more than half of the government subsidies on pregabalin (which reached $154 million in 2016-2017) were spent providing the drugs to these “high-risk users ”.