FDA Initiates Special Investigation of Pradaxa Safety

FDA looks into reports that Pradaxa side effects cause uncontrollable bleeding in patients, leading to hundreds of deaths.

The U.S. Food & Drug Administration (FDA) has announced a special mini-investigation of the blood thinning medication Pradaxa. This investigation comes in response to concerns related to uncontrollable bleeding in Pradaxa patients.

Pradaxa Bleeding Concerns

Blood thinners like Pradaxa are designed to impair the body’s ability to form blood clots, decreasing the risk of certain medical emergencies, like stroke and some types of heart attacks. Unfortunately, blood thinners in general increase the risk of having uncontrollable bleeding, since the body’s ability to form blood clots to stop bleeding has been impaired. However, allegations have surfaced that Pradaxa might be even more dangerous in this respect that regular blood thinning medication. Additionally, older blood thinners like Warfarin can be reversed with high-doses of vitamin K. This means that if uncontrollable bleeding occurs, the blood thinner can be effectively “turned off” by physicians. However, Pradaxa has no such agent. Lawsuits have asserted that this makes Pradaxa more dangerous than older blood thinners like Warfarin.

FDA’s Mini-Sentinel Program

In December 2013, the FDA announced that it would form a mini-sentinel assessment protocol for Pradaxa. This is a type of increased regulatory surveillance to watch for signs that the drug has an increased risk of bleeding. All drugs are subject to postmarket surveillance, a process in which the FDA collects information about potential adverse risks. However, in the case of Pradaxa, the FDA created this program to streamline the process of assessing the risk of uncontrollable bleeding.

The FDA’s public release regarding the mini-sentinel program asserts that FDA scrutiny does not necessarily mean that there is something wrong with a product, and advises patient to not discontinue taking their medication without consulting a physician. In particular, some drugs like Pradaxa can cause problems when discontinued suddenly.

Legal Action

Even as the FDA moves forward with its investigations, former Pradaxa patients and their surviving family members have filed lawsuits against the drug’s manufacturers. These Pradaxa lawsuits allege that drug manufacturers failed to adequately warn patients of the risk of serious health problems, and promoted the drug in spite of the fact that safer alternatives allegedly exist. These lawsuits seek to recoup medical costs and other expenses associated with alleged Pradaxa complications. The lawsuit against the Pradaxa manufacturers has taken the form of multidistrict litigation or MDL.

The Pradaxa MDL is In Re: Pradaxa (Dabigatran Etexilate) Product Liability Litigation, MDL No. 2385, in the U.S. District Court for the Southern District of Illinois.

Seek Help Today

If you or a loved one suffered from uncontrollable bleeding after using Pradaxa, you’ve almost certainly been through a trying ordeal. Uncontrolled bleeding is a medical emergency and requires emergency medical care. In addition to the emotional strain of such a situation, a medical crisis like this can carry substantial financial burdens, like hospital bills, final expenses and lost wages. When facing such challenges, many people feel overwhelmed, or even depressed.

Regardless of the challenges you are facing, it is important to remember that you still have rights, and there are steps that you can take to regain a measure of control over your situation. You can start by visiting the Pradaxa Internal Bleeding Class Action Lawsuit Investigation. Here, you can enter information about your situation for a legal review by a trained expert with a background in this type of litigation.