A new blood-thinning drug may have put around 30,000 Australians at risk of internal bleeding because the drug’s makers withheld safety information, the ABC reports.
Figures obtained by the broadcaster show Pradaxa has been associated with 280 deaths in Australia and 1,400 adverse drug reactions in the past five years.
Abdominal bleeding, brain haemorrhages, strokes and heart attacks were some of the reactions.
By comparison, according to the ABC, the older blood-thinning drug Warfarin has been linked to 30 deaths and 270 reactions over the same period.
The ABC article noted medical experts say the side effects and death figures are disparate because Pradaxa is a new medication and there has been more reporting of adverse events from it compared to Warfarin.
A British Medical Journal investigation released on July 23 found the makers of Pradaxa withheld some of their internal analysis of the new drug because they were worried it would affect sales.
"An investigation by The BMJ shows how the manufacturers of a blockbuster anticoagulant stroke drug withheld from the regulators important analyses regarding how to use the drug as safely and effectively as possible."
The article suggested the medication could be made safer if patients using Pradaxa had their blood levels monitored.
The makers of Pradaxa, Boehringer Ingelheim, issued a statement saying it did not purposely suppress data, and said it had provided expert responses on it's website to the issues raised.
"Ethical behaviour and patient safety are at the core of everything we do," regional medical director for Boehringer-Ingelheim John Smith says in the online statement.
The infomation was unearthed during US court cases over the drug. According to the ABC, Pradaxa's maker, Boehringer Ingelheim, has announced it will pay out $650 million to settle 4,000 lawsuits across the United States.
In Australia, the Therapeutic Goods Administration said while it was aware of the article, there was no new information that would change the risks and benefits of the medication.
Quoted by the ABC, Boehringer Ingelheim said the analysis in question was based on a hypothesis they later found did not stack up, so the information was never released.
In a statement, the company said age and kidney function were the biggest factors in terms of bleeding prevention, not monitoring.
SBS is looking for people that have used the blood-thinning drug Pradaxa and may have concerns after a British Medical Journal investigation released last week found the manufacturer withheld parts of its internal analysis.
If that's you, or you know somebody who has used the drug, email alyshia.gates@sbs.com.au
