As a geriatric social worker I have had the opportunity to observe and help many seniors. I have seen medications on top of medications prescribed. Although physicians are acting in the best interest of their patients, they very rarely are aware of FDA warnings and adverse incident reports of approved medications. Pradaxa ia one of some concern to me in relation to seniors based on their debilitated state, living circumstances and the potential for falls.
In December of last year, the United States Food and Drug Administration published an official "Drug Safety Communication" regarding dabigatran etexilate mesylate, more commonly known by its brand name Pradaxa. According to the FDA release, they have decided to conduct an official investigation regarding the safety of the medication in response to a large number of reports of the deaths of patients prescribed Pradaxa. One month prior to this FDA statement, a European regulatory agency requested that doctors use caution and discretion in their use of the drug as well.
Pradaxa is an anticoagulant. Anticoagulants effect the clotting time of the blood. Pradaxa is described as a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. Pradaxa lowers the chance of blood clots forming in your body.
However while serving as an anticoagulant it has effects on other potentially dangerous situations. Seniors have poor balance and are prone to falling. The thickness of the skin is dramatically reduced which results in tears and bleeding easily. While on Pradaxa extensive bleeding has been noted and some of this extensive bleeding has resulted in serious injury and death. Many seniors live home alone and while on this, should bleeding occur, may not be able to get emergency help fast enough. Seniors are on many medications and many are not eating well and have malnutrition. Such extensive bleeding could be very serious. Should a senior fall and hit his or her head a brain bleed can occur due to the fragile brain vessels in the head. These vessels become more fragile with age. A brain bleed undetected may become fatal. Trauma from a bad fall can cause internal bleeding in the brain or other parts of the body. This bleeding tends to be much worse in people on anticoagulants and falls are more prevalent in senior populations
Gastrointestinal bleeding may also become a problem. Bleeding and ulcers should be monitored on a regular basis by a physician.
Many seniors living alone and do not keep an adequate list of their medications in a place where a paramedic can easily find it. They may be unaware of the Pradaxa. A senor may be found on the floor, and be unable to communicate due to the bleeding and weakened state. I have concerns about the elderly, especially the elderly living alone on these anticoagulants.
Perhaps seniors on Pradaxa should have a nurse or home health aide with them at all times. But, many seniors do not want to lose their independance. Many may not have a loved one near by they can rely on. Unfortunately medicare will not always authorize home heath services on a regular basis for a medication. These periods tend to be time limited and certainly not for a full time live in home health aide.
The Most Common side effects reported for Pradax include: Bruising, major serious bleeding, Bleeding of the brain, gastrointestinal bleeding, rectal bleeding, bleeding from the nose and other extensive bleeding.
My biggest concern with seniors is the potential of a sudden onset of bleeding and an inability to get medical emergency care quickly. I am also concerned about brain bleeds from falls. Should a senior fall and need emergency surgery for a hip fracture we must hope they are able to tell the EMS what meds they are taking. Blood thinners reduce the chance of having a stroke due to a blood clot, but, they have a risk of bleeding. Anticoagulants have been medications causing emergency room visits and hospitalizations.
Pradaxa has been the center of lawsuits and many attorneys are reviewing Pradaxa cases for extensive bleeding and death. Should you or your loved one taking Pradaxa have extensive bleeding resulting in severe complications or death you should contact an attorney to discuss the potential for a Pradaxa lawsuit. Call the Pradaxa Helpline and Speak to A Medical Social Worker and a Pradaxa lawyer.