Dodgy meds linked to deaths, blisters, chest pain and breathing problems

Australian patients are being dispensed a dodgy generic medication found to be causing alarming side effects.

Australian patients are being dispensed a dodgy generic medication found to be causing alarming side effects including chest pain, breathing difficulties and blisters.

Faulty batches of generic lamotrigine tablets – an anticonvulsant drug commonly used for treating bipolar disorder and epilepsy – were discovered by a University of NSW study.

The same type of medication has also been associated with four deaths in Australia since 2018.

Three formal notifications about problems with the medication have been made to the Therapeutic Goods Administration (TGA) in recent years but the expert who raised the alarm has had no response from the agency.

Study author Professor Gordon Parker – founder of the Black Dog Institute and the Scientia Professor of Psychiatry at UNSW – is calling for the TGA to urgently investigate the quality of the medications.

“There is obviously a concern I have about TGA seemingly not following up on substantive concerns and I know this sounds a little bit grandiose, but I’ve been a professor for a long period of time, I think I’m reasonably well respected,” Prof Parker said.

Professor Gordon Parker, Founder of the Black Dog Institute. Picture: John Appleyard

His research published in the journal Australasian Psychiatry concludes the compromised product is likely a result of poor quality controls during the overseas manufacturing process.

Professor Parker did his own detective work on the drug after the TGA ignored his concerns and two of his patients experienced alarming side effects.

One patient developed spots, lumps and blisters following the switch to a low dose generic brand of the drug.

The side effects ceased when the patient switched back to the non-generic version of the drug, even at an increased dosage, he said.

Another patient – who was not previously prescribed lamotrigine – developed breathing issues, chest pain, hot flushes, nausea and a worsening depression on a low dosage.

Professor Parker paid for scientific mass spectrometry testing of six lamotrigine preparations distributed in Australia and two generic versions of the drug used by two patients reporting side effects.

The drugs taken by the two patients who suffered adverse side effects were found to contain higher amounts of lamotrigine concentration, Professor Parker said.

“It’s not that one particular product is bad, but the generics they were taking seem to be associated with some reasonably toxic side effects, and the irregularities we found from the assays support a faulty batch explanation,” he said.

Some manufacturers don’t do temperature checks on drugs. Picture istock

When he rang the different companies and asked whether they had temperature checks on the containers that shipped drugs to Australia not all of them did.

“One company independently told me that they have to get rid of that 20 per cent of products they bring from overseas because it’s been heat dysregulated and I think usually because containers are being left out on tarmacs at airports,” he said.

“So reputable companies have checks and balances. And it makes us wonder what the generic manufacturers are doing.”

Australia is not the only country experiencing problems with the drug; there have been issues in the US and the UK.

In 2019 a coronial inquiry was held into six deaths associated with the generic medication in New Zealand.

The deaths occurred after that country’s medicines body Pharmac advised there would be only one funded brand of the anti-epilepsy drug lamotrigine, Logem,

However, when the inquiry reported in 2021 it found “no clear evidence” to link the brand switch to the seizures that led to the six deaths.