Drug changes have not been ruled out as a cause of epilepsy death, a neurologist report states

By Guyon Espinar of RNZ

The first official recognition that the rebranding of epilepsy drugs could have been the cause of at least one of the six deaths was revealed when the chief coroner’s investigation into the rebranding began today. became.

A change in the brand of the anticonvulsant lamotrigin could not be ruled out as a factor in the death of Auckland’s 31-year-old man Andre Maddock last December, according to a report to a neurologist coroner.

However, the magnitude of the role that brand switching played in the deaths of Maddock and five other epilepsy patients is unlikely to be a major factor in the initial report to the coroner. It seems that there is a fierce battle in the cause of death inquiry. Other death.

With Maddock’s death, his partner Nadia Jost left a big hole in their lives with their little son Lucas.

“One day it was okay, but the day Lucas really needed that example, his father’s figure, it hit me a little more, and it’s the whole of how unfair the death of a loved one is. It brings a lot of emotions, “said Jooste.

More than 10,000 people with epilepsy have been forced to switch the lamotrigine brand from the Dynamictal and Arrow brands, where 90% of it was used, to a generic drug called Logom.

Pharmac, a drug purchasing agency, sought to save $ 30 million over five years and free up money spent on other drugs, but advised MedSafe that brand switching poses a safety risk. On the contrary, I switched to lamotrigin.

“I’m angry because it’s like a choice robbed from everyone switched. They seem to have given cheaper generics because someone wanted to save money. I did, “said Jooste.

Neurologist Elizabeth Walker reported that brand switching could not be ruled out as a factor in Maddock’s death.

However, she said the most likely cause was an increase in drug dose in line with the brand change.

RNZ has seen neurologist reports on two of the other five deaths, both of which are unlikely to be due to brand changes.

The study focuses on the safety risks of changing between epilepsy drug brands, rather than suggesting that either drug is inferior.

Documents prepared for the study include a report from Natalie Medicot, an academic pharmacist at the University of Otago, who said there was a risk of diminished control of epilepsy when patients switched brands of lamotrigin. It was.

This is because lamotridin was a drug known as a narrow therapeutic range. That is, even the slightest difference in dose can have a significant impact.

The submission prepared by Medsafe for the Inquest of the Chief Coroner showed similar points, outlining why the Pharmac objected to the Pharmac brand change.

Most generics are free to replace, but the range of treatment is narrow and some antiepileptic drugs fall into this category, requiring a small number of drugs to be prescribed by brand.

“Several patients experience clinical differences in the amount of active ingredient that reaches the blood,” said the Medsafe submission.

“In the case of antiepileptic drugs, changes in blood levels of the active ingredient can cause serious adverse events in the patient.”

Pediatric neurologist Cynthia Sharpe has vowed to be seriously concerned that brand switching may be involved in death.

Arabella Guvey, an advocate for patients with epilepsy in her daughter, said the number of reported adverse side effects had increased 30-fold and the number of deaths had doubled after the brand switch.

“Coroners hold 10-year data showing that this group of epilepsy patients taking lamotrigine had an average of 3 deaths per year for about 10 years before the switch. At least 7 people have been confirmed dead. 1st year. “

Pharmac emphasized that the Lamotrigin Logom brand is widely used around the world, is completely safe and should not be stopped if people are using this drug today.

However, despite the controversy, RNZ can reveal that Pharmac has considered another brand switch for epilepsy drugs in August this year.

“The fact that Pharmac had put epilepsy drugs on the table for further switching was angry, and the Ministry of Health urgently intervened to implement international brand switching guidelines, claiming that Pharmac would follow them. It shows that we need to do it, “Gubey said.

In response to opposition from New Zealand epilepsy, Pharmac quietly shelved the proposal.

“I’m very happy because they said they weren’t happy with the inclusion of these epilepsy drugs and Pharmac’s removal of them,” said Ross Smith, CEO of Epilepsy, New Zealand. Said.

Nadia Jost said she was happy to spend at least a day in court as she faced Andre’s second Christmas.

Like other relatives, she still didn’t know what role the brand switch played in the death of her partner, but she felt she couldn’t make informed choices.

“If they’re going to change drugs, make sure they sign with a dotted line that they understand the side effects,” she said. “It’s just giving someone a choice. The choice was robbed of these deceased loved ones.”

The inquest begins this morning in the Auckland District Court.