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Following in the Footsteps: The Saga of the Xarelto Lawsuit

It should not come as a surprise that the first Xarelto lawsuit has been filed barely three years after the anticoagulant drug was approved in July 2011 by the Food and Drug Administration (FDA) initially as prophylactic treatment for patients that had recently undergone hip or knee replacement surgery and later for atrial fibrillation, pulmonary embolism, and deep vein thrombosis. After all, its predecessor though not class-mate Pradaxa (dabigatran) from Boehringer Ingelheim got FDA approval in 2010 is already knee-deep in lawsuits for bleeding side effects. Why should manufacturer Bayer Corp. and US distributor Janssen Ortho LLC (a division of Johnson & Johnson) expect anything different? Both Xarelto and Pradaxa are alternatives to the standard anticoagulant medication warfarin, which proved its efficacy in reducing the incidence of blood clots as far back as 1950. The problem with warfarin was that it was difficult to administer; it required regular monitoring and frequent dosage adjustments to account for interactions with certain foods. Xarelto and Pradaxa, on the other hand, were taken once a day and did not require regular monitoring for safe use. On the downside, both Xarelto and Pradaxa have no known reversal agent unlike warfarin which could be effectively and immediately counteracted with a dose of Vitamin K, so when a patient starts bleeding in reaction to a dose of either Xarelto or Pradaxa, they’ll continue bleeding until the drug flushes out of the system. Not good. Xarelto is a direct factor Xa (10-a) inhibitor, also known as a xaban, a class of anticoagulants that acts directly on factor Xa of the coagulation cascade. Pradaxa, on the other hand, is a direct thrombin inhibitor. This difference makes no difference, so to speak; both classes of anticoagulants share the same problem of uncontrollable bleeding with no way of reversing it. Warfarin also had this issue, but it could be reversed....
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The Pros and Cons of Taking Risperdal

The benefits manifested by the anti-psychotic drug Risperdal during the years immediately following its release plus the claim that is causes lesser side effects compared to other drugs intended to treat brain-related illnesses, enabled it to gain immediate popularity in the medical field. This acceptance led to the issuance of more than 10 million prescriptions by the end of October 2011. The use of Risperdal was approved by the US Food and Drug Administration in 1994; it is prescribed to patients to treat mixed or manic episodes of bipolar disorder, long-term treatment of bipolar disorder, irritability due to autistic disorder and schizophrenia. By altering the effects of chemicals (called neurotransmitters) in the brain, Risperdal is able to affect abnormal brain communication, which is the cause of psychotic illness, and improve the condition of the patient. Besides the FDA-approved use of Risperdal, doctors also prescribe the drug for off-label use, such as in treatment of obsessive-compulsive disorders, Tourette syndrome and stuttering. The year 2003 was marked with reports of severe side-effects and fatalities that, allegedly, were caused by Risperdal. Incidences of strokes, deaths and the development of Neuroleptic Malignant Syndrome or NMS (a deadly condition caused by the rigidity of the muscles and irregularities in blood pressure) and Tardive Dyskinesia (uncontrolled twitching of the face and/or tongue and uncontrolled movement of the limbs caused by a disorder in the central nervous system). A 2010 study on Risperdal, however, found that the drug makes no improvement on the social skills and conversational ability of children with autism and that the obsessive behavior of many autistics has not been reduced. The study also showed that, though, Risperdal may have provided some benefits to people suffering from dementia, the incidences of stroke and death were still higher. Some of the other reported side effects and complications from Risperdal include heart failure, diabetes, bone...
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Defective Pharmaceutical Products

Modern medicine has undoubtedly been a boon to mankind in incalculable ways. The life span has more than doubled from the early 20th Century of 31 years to the 67.2 years of today worldwide as medical knowledge, technology, and practice significantly improved by leaps and bounds in the last 100 years or so. Sometimes, however, there are defective pharmaceutical products that cuts life short, or considerably impair a patient’s health for no reason other than a breach of the duty of care. Pharmaceutical companies have been the brunt of numerous personal injury lawsuits in the last two decades, and in most cases for good reason. An article on the website of Williams Kherkher discusses the health complications associated with the transvaginal mesh, illustrating how an otherwise good product can go so very wrong when not enough research is made for certain uses. While surgical mesh is effective for temporary support during surgical procedures and to repair hernias, its application for age-related medical conditions such as incontinence and pelvic organ prolapse in women has been far from efficacious. This is why numerous drug companies are being sued for failing to do the necessary clinical testing prior to widespread sale to the public. Another example of a good thing going wrong because of a lack of adequate clinical trials is Topamax (topamirate), a drug used in the treatment of epilepsy developed and marketed Johnson & Johnson divisions Ortho-McNeil Neurologics and Noramco, Inc. When administered to pregnant women, Topamax caused birth defects such as cleft lip, cleft palate, and hypospadias. The breach of duty occurred when the drug was touted as safe for pregnant women when later developments proved it definitely posed considerable risks for the unborn child. While drugs and medical devices have saved countless lives, it is important that pharmaceutical companies test their products thoroughly to ensure its safe use....
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