An Australian mother who survived horrific burns to more than half of her body claims after she set herself on fire, the painkiller she was prescribed is to blame.
Vicky Edwards, 48, told A current matter she is now speaking out to warn others about Lyrica, 18 months after she suffered horrific burns.
“Lyrica has helped me well and correctly,” claims Edwards.
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Lyrica, also known as Pregabalin, was originally prescribed to treat epilepsy and nerve pain.
But now it is often distributed to patients with chronic pain.
It was manufactured by Pfizer and was added to the Australian Pharmaceutical Benefits Scheme in 2013.
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Edwards claims she was prescribed the drug for nerve pain after she injured her back during exercise and ended up with “three disc bulges.”
She believes six weeks is enough for the medication to take over her mind.
“I just wasn’t myself and it cost me everything,” Edwards said.
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She said she was taking 150 milligrams a day and that it was of no use to her.
On January 22, 2021, Edwards’s life began to spiral out of control.
“My oldest daughter put me on the bed and said, ‘Mom, this isn’t real, this isn’t happening, this isn’t you,'” she said.
Forty-eight hours later, the situation escalated.
“I set myself on fire and ran outside on fire…screaming,” Edwards said.
“I can’t remember the pain and my neighbor came out because I was screaming…that man and his wife saved my life.”
Edwards spent the next two months in a coma with burns on 54 percent of her body.
“I was covered in bandages from head to ankle, you could just see my eyes… and I knew I was in trouble… I knew it was bad because I couldn’t move,” said the 48-year-old year old mother.
“I was in a lot of pain, I remember that.”
Until now, doctors had assumed that Edwards had tried to take his own life in a violent and very devastating way.
But Edwards always thought it was something else.
“Lyrica did this to me,” Edwards claims.
dr. Stephen Salerno is Edwards’ burn surgeon at the Alfred Hospital in Melbourne.
“One day you are completely normal and within seconds your life is completely taken from you – what it was – and you have to rebuild it,” Salerno said of Edwards’s situation.
Salerno is now preparing Edwards for another major operation.
It will be Edwards’ 16th surgery and it won’t be the last.
Her recovery will continue for the rest of her life, and every day she puts her strength to the test.
Psychiatrist, Dr Tanveer Ahmed claims, “there seems to be a clear association with Lyrica and self-harm and suicidal thoughts”.
“Anyone with any sort of mental health history, anyone with any sort of psychological vulnerability, they seem to be at much greater risk…thoughts of self-harm, suicidal ideation, bouts of uncontrollable anger that they’ve never had before,” he said.
“The challenge is linking it directly to the drug because there are usually so many other factors that can interact with Lyrica.”
Ahmed said educating patients is crucial.
“It should be the responsibility of GPs that this carries risks, namely addiction, dependence and a higher risk of suicidal or self-harm thoughts… these risks should be communicated to patients,” Ahmed said.
In the US, Pfizer has been prosecuted for marketing Lyrica and ordered to pay $2.3 billion for illegal marketing.
Edwards wants to lead a class action in Australia.
“A class action could really put the microscope on the exact evidence linking Lyrica to potential harm, such as self-harm; suicidal thoughts and getting the real microscope… Getting Lyrica in a court of law,” Ahmed said.
In a statement to A current matter a Pfizer spokesperson said, “Lyrica is no longer a Pfizer product.”
A full statement from a spokesperson for Viatris, the current owner, is below.
If you or someone you know needs immediate support, please contact Lifeline on 13 11 14 or lifeline.org.au†
In an emergency, call 000.
If you or someone you know would like to talk to someone confidentially about addiction, please contact Lifeline on 13 11 14 or visit Reach Out.
In an emergency, call 000.
Full statement from a Pfizer spokesperson:
“Lyrica is no longer a Pfizer product.”
Full statement from a Viatris spokesperson:
Patient safety and the correct use of our medicines is of the utmost importance to our business. It is important to note that pregabalin should only be used when prescribed by a physician, and when properly prescribed and administered, according to the approved label, this drug is an important treatment option for many patients. The efficacy and safety of this drug has been demonstrated in a large number of robust clinical studies in thousands of patients in the approved indications 1-19.
As with all of our medicines, we remain committed to properly communicating important safety information to healthcare professionals to educate them about the appropriate use of the medicine so that they can make an informed decision about risk versus benefit in consultation with their patients. the Australian Product information (for doctors) and Consumer Medicine Information (for patients) available on the Therapeutic Goods Administration website contains details about pregabalin for prescribers and patients to support the safe use of the drug. According to pregabalin’s prescribing information, all anticonvulsants may increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication 20, 21. Current labeling of pregabalin accurately reflects these risks and provides guidance for physicians in identifying appropriate patients and supervision of their treatment.
References:
1. Dworkin RH, Corbin AE, Young JP Jr, Sharma U, LaMoreaux L, Bockbrader H, Garofalo EA, Poole RM. Pregabalin for the treatment of postherpetic neuralgia: a randomized placebo-controlled trial. Neurology. 2003;60:1274-83.
2. Arroyo S, Anhut H, Kugler AR, Lee CM, Knapp LE, Garofalo EA, Messmer S, and the Pregabalin 1008-011 International Study Group. Add-on treatment with pregabalin: a randomized, double-blind, placebo-controlled dose-response study in adults with partial onset seizures. epilepsy. 2004;45:20-7.
3. Brodie MJ. Pregabalin as adjunctive therapy for partial seizures. epilepsy. 2004;45(suppl 6):19-27.
4. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves the symptoms of painful diabetic neuropathy: a randomized clinical trial. Neurology. 2004;63:2104-10.
5. Rosenstock J, Tuchman M, LaMoreaux L, Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled study. Pain. 2004;110:628-38.
6. Sabatowski R, Gálvez R, Cherry DA, Jacquot F, Vincent E, Maisonobe P, Versavel M, The 1008-045 Study Group. Pregabalin reduces pain and improves sleep and mood disorders in patients with postherpetic neuralgia: results of a randomized placebo-controlled clinical trial. Pain. 2004;109:26-35.
7. Beydoun A, Uthman BM, Kugler AR, Greiner MJ, Knapp LE, Garofalo EA, and the Pregabalin 1008-009 study group. Safety and efficacy of two pregabalin regimens for adjunctive treatment of partial epilepsy. Neurology. 2005;64:475-80.
8. Elger CE, Brodie MJ, Anhut H, Lee CM, Barrett JA. Add-on treatment with pregabalin in patients with partial seizures: a new evaluation of flexible and fixed dose treatment in a double-blind, placebo-controlled study. epilepsy. 2005;46:1926-36.
9. Freynhagen R, Strojek K, Griesing T, Whalen E, Balkenohl M. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomized, double-blind, multicenter, placebo-controlled study of flexible and fixed-dose regimens. Pain. 2005;115:254-63.
10. Richter RW, Portenoy R, Sharma U, LaMoreaux L, Bockbrader H, Knapp LE. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized placebo-controlled trial. J Pain. 2005;6:253-60.
11. Siddall PJ, Cousins MJ, Otte A, Griesing T, Chambers R, Murphy TK. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled study. Neurology. 2006;67:1792-1800.
12. van Seventer R, Feister HA, Young JP Jr, Stoker M, Versavel M, Rigaudy L. Efficacy and tolerability of twice daily pregabalin for the treatment of pain and related sleep interference in postherpetic neuralgia: a 13-week randomized trial. Curr Med Res Opin. 2006;22:375-84.
13. Freynhagen R, Grond S, Schüpfer G, Hagebeuker A, Schmelz M, Ziegler D, Von Giesen HJ, Junker U, Wagner KJ, Konrad C. Efficacy and safety of pregabalin in the treatment of refractory patients with different neuropathic pain entities in clinical routine . Int J Clin Pract. 2007;61:1989-96.
14. Siddall PJ, Cousins M, Otte A, Griesing T, Chambers R, Murphy K. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled study [reply from authors]† Neurology 2007;68;2159-60.
15. Arezzo, JC, J. Rosenstock, L. Lamoreaux and L. Pauer. Efficacy and safety of pregabalin 600 mg/d for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled study. BMC Neurol. 2008;8:33.
16. Baron, R., U. Brunnmuller, M. Brasser, M. May and A. Binder. Efficacy and safety of pregabalin in patients with diabetic peripheral neuropathy or postherpetic neuralgia: open-label, non-comparative flexible-dose study. Eur J Pain. 2008;12:850-8.
17. Freeman R, Durso-DeCruz E, Emir B. Efficacy, safety and tolerability of pregabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized controlled trials with a range of doses. Diabetes Care. 2008;31:1448-54.
18. Stacey BR, Dworkin RH, Murphy K, Sharma U, Emir B, Griesing T. Pregabalin in the treatment of refractory neuropathic pain: results of a 15-month open-label study. Pain Med. 2008;9(8):1202-8.
19. Tölle T, Freynhagen R, Versavel M, Trostmann U, Young JP Jr. Pregabalin for the relief of neuropathic pain associated with diabetic neuropathy: a randomized, double-blind study. Eur J Pain. 2008;12:203-1
20. FDA Report (May 23, 2008): Statistical Review and Evaluation: Antiepileptic Dugs and Suicidality.
21. FDA recommends suicide risk warning for epilepsy drugs (webmd.com: dated Dec 16, 2008; webmd.com/epilepsy/news/20081216/epilepsy-drugs-get-suicide-risk-warning†
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