The Australian mother, who survived severe burns in more than half of her body after the burn, claims that the pain medication prescribed for her is to blame.
Vicky Edwards, 48, said Current affair she is now speaking to warn others against Lyrica 18 months after suffering terrible burns.
“Lyrica got me well,” says Edwards.
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Lyrica, also known as Pregabalin, was originally prescribed to treat epilepsy and nerve pain.
However, it is now often used in patients with chronic pain.
It was manufactured by Pfizer and in 2013 was added to the Australian Pharmaceutical Benefits Scheme.
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Edwards claims she was prescribed a cure for nerve pain after injuring her back during training and ending up with “three plate bulges.”
She believes that six weeks was enough for the drugs to take over her mind.
“I just wasn’t myself and it all cost me,” Edwards said.
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She said she takes 150 milligrams a day and things make no sense to her.
On January 22, 2021, Edwards’ life began to spiral out of control.
“My oldest daughter sat me on the bed and said, ‘Mom, it’s not real, it’s not happening, it’s not you,'” she said.
48 hours later, the situation escalated.
“I got on fire and ran out … screaming,” Edwards said.
“I don’t remember the pain and my neighbor came out because I was screaming … the 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 with bandages from head to toe, only my eyes could be seen … and I knew I was in trouble … I knew it was bad because I couldn’t move,” said the 48-year-old mother.
“I was in a lot of pain, I remember.”
Until now, doctors assumed that Edwards had tried to take her own life in a violent and most devastating way.
But Edwards always thought it was something else.
“Lyrica did this to me,” Edwards says.
Dr Stephen Salerno is Edwards’ burn surgeon at Alfred Hospital in Melbourne.
“One day you’re completely normal and in a few seconds your life is taken away – as it was – and you have to rebuild it,” Salerno said of Edwards’ situation.
Salerno is now preparing Edwards for another major operation.
It will be Edwards’ 16th operation and it will not be the last.
Her recovery will continue for the rest of her life and she tests her strength every day.
The psychiatrist, Dr. Tanveer Ahmed, claims, “there seems to be a clear link between Lyrica and self-harm and suicidal thoughts.”
“Anyone with any mental history, anyone with any mental vulnerability, seems to be at a much greater risk … thoughts of self-harm, suicidal thoughts, fits of uncontrollable rage they have never had before,” he said.
“The challenge is to link it directly to the drug, because there are usually many other factors that can play a role with Lyrica.”
Ahmed said patient education was key.
“It should be a burden on GPs that it carries risks, namely addiction, addiction and a higher risk of suicidal or self-harming thoughts … these risks need to be communicated to patients,” Ahmed said.
In the United States, Pfizer was prosecuted for marketing to Lyric and ordered to pay $ 2.3 billion for illegal marketing.
Edwards wants to file a class action lawsuit in Australia.
“A class action could actually build a microscope on accurate evidence that links Lyrica to potential harm, such as self-harm; suicidal thoughts and get a real microscope, get … Lyrica to court,” Ahmed said.
In the statement on Current affair A Pfizer spokesman said: “Lyrica is no longer a Pfizer product.”
The full statement of the Viatris spokesman, the current owner, is set out below.
If you or someone you know needs immediate support, contact Lifeline at or through 13 11 14 lifeline.org.au.
In an emergency, call 000.
If you or someone you know would like to talk to someone about addiction, contact Lifeline at 13 11 14 or visit Reach Out.
In an emergency, call 000.
Full statement from Pfizer spokesman:
“Lyrica is no longer a Pfizer product.”
Viatris spokesman’s full statement:
Patient safety and the proper use of our medicines are of the utmost importance to our society. It is important to note that pregabalin should only be used if it is prescribed by a doctor, and if it is prescribed and administered correctly according to an approved label, this medicine 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 trials in thousands of patients in approved indications 1-19.
As with all our medicines, we remain committed to ensuring that important safety information is properly communicated to healthcare professionals so that they can teach them how to use the medicine properly so that they can make an informed risk-benefit decision in consultation with their patients. Australian Product information (for doctors) and Consumer medicine information (for patients), which is available on the Therapeutic Goods Administration website, contains details of pregabalin for prescribers and patients to support the safe use of the drug. According to prescribing pregabalin, all antiepileptic drugs may increase the risk of suicidal thoughts or behavior in patients taking these drugs in any indication 20, 21. The current labeling of pregabalin accurately reflects these risks and provides physicians with guidance in identifying suitable patients and monitoring their treatment.
Reference:
1. Dworkin RH, Corbin AE, Young JP Jr, Sharma U, LaMoreaux L, Bockbrader H, Garofalo EA, Poole RM. Pregabalin for the treatment of post-herpetic neuralgia: a randomized, placebo-controlled study. Neurology. 2003; 60: 1274-83.
2. Arroyo S, Anhut H, Kugler AR, Lee CM, Knapp LE, Garofalo EA, Messmer S and the Pregabalin International Study Group 1008-011. Pre-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 in partial onset seizures. epilepsy. 2004; 45 (suppl 6): 19-27.
4. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin alleviates 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 post-herpetic 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 Pregabalin Study Group 1008-009. 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 onset 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 study. 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 pregabalin twice daily for the treatment of pain and related sleep interference in postherpetic neuralgia: a 13-week randomized study. 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 various neuropathic pain entities in clinical practice. 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 / day 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 post-herpetic neuralgia: An open-label, non-comparative study with flexible dosing. Eur J Pain. 2008; 12: 850-8.
17. Freeman R, Durso-DeCruz E, Emir B. Efficacy, safety and tolerability of pregabalin treatment in painful diabetic peripheral neuropathy: findings from seven randomized, controlled studies at various 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 neuropathic pain relief 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 Excavations and Suicide.
21. The FDA mandates suicide warnings for epilepsy drugs (webmd.com: 16 December 2008; webmd.com/epilepsy/news/20081216/epilepsie-drugs-get-suicide-risk-warning)
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