Once again, drug manufacturer, AstraZeneca finds itself in the hot seat for manipulating trial data. This time prescription blood thinner medication, Brilinta is at the center of the controversy. The U.S. Justice Department even investigated the company for allegedly downplaying and even downright hiding information about the problems linked to Brilinta in a late-stage clinical trial.
Brilinta is a medication that keeps blood platelets from clotting to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions. It is supposed to lower the risk of stroke or serious heart problems after a patient has had a heart attack.
In 2009, AstraZeneca presented data from a clinical trial that compared the drug to its main competitor, Plavix. The study of 18,000 patients claimed that Brilinta was more effective than Plavix. The FDA approved the drug in 2011 based on these results.
Now, there is a suspicion that data from Brilinta’s clinical trial regarding adverse events such as uncontrollable bleeding were omitted from the initial submission made to the FDA. It was discovered that at least 23 instances of people experiencing side effects were left out of the results, and the manufacturer downgraded many adverse events to a lesser side effect.
Other suspicious data from the trial includes 21% of the subject pool is from Poland and Hungry vs the US or Canada, half of those patients from Poland or Hungry had successful results while on Brilinta, and patients could tell if they were receiving Plavix or not by breaking open the tablet.
These very serious trial flaws granted a dangerous medication market approval. There isn’t even an antidote for the uncontrollable bleeding. Emergency personnel doesn’t have any option to swiftly reverse the effects of Brilinta. They have to wait for the effects of it to wear off, while their patients continue to bleed.
Moreover, this drug has over 455 known drug interactions. This includes a total of 1,791 brand and generic names. That number is staggering enough, but if trial data was tampered with, how many more medications are out there that could interact with dangerous Brilinta?
This news is quite unsettling, but we are here to help. If you or a loved one have experienced uncontrollable bleeding from Brilinta, please call us at 877-513-9517.