A new study has questioned the Food and Drug Adminstration’s (FDA) process for approving new prescription drugs, especially after the agency allowed a trio of products to reach the market without serious questions about their safety being answered, including the blood thinner Pradaxa. Pradaxa side effects have been blamed for more than 250 deaths since it was first introduced, mostly from incidents of Pradaxa traumatic bleeding, including bleeding in the brain and gastrointestinal bleeding.
According to a Wall Street Journal report on a study appearing in the latest edition of the Journal of the American Medical Association, approval of the drugs Caprelsa, Gilenya, and Pradaxa should raise the level of concern on whether the FDA has the public’s safety in mind when it allows new drugs onto the market.
Most notably among those drugs is Pradaxa, a blood thinner prescribed to patients suffering from a form of atrial fibrillation. Pradaxa was designed be a warfarin replacement. Warfarin, also known by the brand name Coumadin, as the leading blood thinner in the prevention of blood clots that could lead to heart attack, stroke, and death. During its short time on the market, Pradaxa has been linked to numerous reports of serious side effects, chief among them the risk patients face of suffering a serious Pradaxa bleeding or Pradaxa hemorrhaging episode.
Unlike its predecessor, Pradaxa has no antidote and a patient taking the drug who suffers even a minor cut is at risk of experiencing one of these Pradaxa bleeding episodes. The bleeding spreads quickly and because there is no antidote, doctors are basically helpless in stopping it. This often results in death for a patient. And since it was first introduced in 2010, Pradaxa has been linked to more than 250 deaths.
That alone has raised alarms on the safety of the drug and the new study from researchers with the drug safety advocacy publication QuarterWatch and Wake Forest University believe the FDA’s flawed approval process could be letting this and other newly-approved drugs onto the market without being properly tested for safety.
According to the study, which cited FDA statistics, the agency approved 35 new drugs in 2011, nearly the high mark for the last 10 years. Of them, 16 were approved through some expedited manner.
Of the other drugs included in the study, Caprelsa – a drug used to prevent the spread of thyroid cancer – had the most dangerous profile. The study found that when it was compared to a placebo, patients taking it were no more likely to prevent the spread of cancer.
Gilenya, a drug approved to be given to patients suffering from multiple sclerosis (MS), had seven major issues with it that put people taking it at greater risk of suffering a serious side effect, including causing a dangerous heart rate that could lead to death. The drug did show signs that it was slightly more effective than previous drugs.
Drug companies petition the FDA to have drugs approved through expedited means on the argument that requiring more extensive pre-market testing could be preventing people who could really use the drug as a life-saving measure from receiving it.
Pre-market testing is also very expensive, costing a manufacturer millions of dollars all in the hope that the agency will give its approval.