Australia (Commonwealth Union) – Researchers from the University of New South Wales (UNSW) have warned that certain adverse reactions to bipolar and epilepsy drugs may be due to compromised products.
Unusable batches of generic lamotrigine tablets, which is a drug generally used for treating epilepsy and to stabilize bipolar disorder have been given to patients in Australia. The compromised product is possibly due to poor quality controls in the overseas manufacturing process, according to researchers.
The study, published in the medical journal Australasian Psychiatry, was carried out with mass spectrometry evaluating 6 lamotrigine preparations distributed across Australia and 2 generic versions of the drug taken by 2 patients reporting side effects. Even though evaluations of the 6 preparations were comparable and indicated no signs of compromising, the assays of the drugs taken by the 2 patients indicated deviations in the lamotrigine levels.
Scientia Professor of Psychiatry at the School of Clinical Medicine, UNSW Medicine & Health, Gordon Parker, who was the lead author of the study, stated that the findings do not indicate that all generics were universally compromised, however their evaluations show certain compromised lamotrigine drugs being distributed across the country.
The evaluations of the 2 individual generics demonstrated higher lamotrigine concentrations contrasted to the non-generic brands. Although it isn’t certain whether the compromised product alone could explain the patients’ side effects, Prof. Parker says it’s unlikely they were just experiencing regular side effects.
Researchers also looked into the products’ manufacturing origin and transporting conditions. When contacted 5 companies indicated that their product was manufactured in India, which was sent to Australia by ship or plane. Just 3 companies verified the products temperature was controlled and checked following transit.
“It’s possible that being transported to Australia, they might be exposed to excessive heat or cold and may break down. But we suspect there are some manufacturing sites where the product is being compromised or contaminated after receiving TGA approval,” said Professor Parker.
