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ROBERT KITCHEN / Things
Medsafe group manager Chris James told the chief coroner that the agency told Pharmac it was “undesirable” for patients to switch brands of lamotrigine, an epilepsy drug before a funding change.
The drug safety authority warned Pharmac that it was “undesirable” for patients to switch brands of an epilepsy drug that is now the focus of a coronary investigation.
On Monday, Chief Coroner Deborah Marshall opened the second part of the investigation into the deaths of six New Zealanders who died while taking Logem, a generic form of the anti-seizure drug lamotrigine.
In 2019, a change in Pharmac funding resulted in 11,000 New Zealanders changing their medications, a measure that has reported seven deaths to the Adverse Reports Monitoring Center as possibly related to the change.
On Tuesday, Chris James, a group manager for drug regulator Medsafe, told the coroner that the agency raised concerns with Pharmac when the change was first proposed in 2018.
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In November, Marshall heard from families as part of an investigation into the cause and circumstances of the deaths, and whether the rebrand affected seizure control.
Pharmac initially funded three brands of lamotrigine, also used to treat bipolar disorder: Lamictal, Arrow-Lamotrigine, and Logem.
Pharmac announced its proposal to move to a funded brand in August 2018.
DAVID BLANCO / THINGS
Chief Coroner Deborah Marshall has resumed her joint investigation into the deaths of six New Zealanders who died while taking the epilepsy drug Logem.
The international consensus is that most drugs can be freely substituted by a generic, which contains the same active ingredient in the same amount as the innovative (original) brand.
For most people, a generic will be the same as the innovator. However, a “very small percentage” of people experience “clinically significant lower or higher levels” reaching their blood, James said.
As such, there is a “small” group of drugs where prescribing by brand is recommended, including some epilepsy drugs, he said.
A change in the blood level of the active ingredient with any antiepileptic drug can result in significant adverse events, James said.
SUPPLIED / Stuff.co.nz
In October 2019, after funding three different forms of lamotrigine, an anti-seizure drug, Pharmac went on to fund Logem alone, prompting hundreds of adverse reaction reports and linked to at least six deaths.
Given the evidence, Medsafe said it was “important to remind Pharmac that it was not desirable for patients to switch brands of lamotrigine.”
Logem is bioequivalent (without significant differences) to the ‘groundbreaking’ Lamictal, and has been shown to be safe, James said.
Each batch of Logem undergoes rigorous quality, safety and efficacy testing before it can be released to the market.
However, bioequivalence testing between generic drugs is not required, so “we don’t know if Arrow-Lamotrigine and Logem are bioequivalent.”
Keith Srakocic / AP
Change is at the center of hundreds of adverse reaction reports, with people reporting seizures, memory loss, spasms, headaches, confusion, and mood problems.
James told the coroner that Medsafe was concerned if patients with well-controlled seizures experienced “clinically significant differences” this could have had a “profound impact.”
He also expressed concern for patients who had difficulty finding the right treatment regimen or the right dose.
James said Medsafe “did not feel that a rebrand should be done unless there was careful patient monitoring, careful patient supervision, in accordance with international guidelines.”
In April 2019, Pharmac announced that the change would go ahead, allowing five months to phase out other brands before funding only Logem starting in October, save in exceptional circumstances.
Several families told the medical examiner that they and their loved ones were unaware of the rebrand and had little education about the change. Some reported that their medications changed multiple times.
While Medsafe “did not change its mind” regarding the change, the introduction of the exceptional circumstances process and the extension of the implementation period appeared to have “the potential to mitigate” some “anticipated problems,” James said.
Change is at the center of hundreds of adverse reaction reports, with people reporting seizures, memory loss, spasms, headaches, confusion, and mood problems.
James extended his “condolences” to the families affected by the change.
The second part of the investigation will finish next week.
