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Dangerous Drugs Injury Attorney
Fighting for those injured by dangerous / defective drugs in Alabama and Nationwide
Defective Drugs Legal Overview
People rely on medications to treat a wide variety of illnesses. Most of today’s medicine work as advertised and have manageable side effects. But occasionally we learn about drugs that are unreasonably dangerous.
The pharmaceutical industry is a booming business in the United States. Pharmaceutical companies spend approximately $30 billion a year advertising their drugs to physicians and to the public. This is nearly 3x as much as they spend on drug safety research.
The most stunning statistic, however, is that the total number of deaths caused by conventional medicine is an astounding 783,936 per year . It is now evident that the American medical system is the leading cause of death and injury in the US. (By contrast, the number of deaths attributable to heart disease in 2001 was 699,697, while the number of deaths attributable to cancer was 553,251).
What are the Dangers with Prescription Drugs?
Although medications must go through many tests and clinical trials before being approved for use, often serious health risks become apparent only after a drug has been aggressively marketed and prescribed to millions of patients. This may be true even if those risks may have been apparent to manufacturers in early clinical trials. Drug makers invest millions of dollars in developing these medications, which can make it tempting to turn a blind eye to early warning signs of trouble.
Some serious adverse events that have been associated with prescription drugs include blood clots, irregular heart rhythm and heart attack, stroke, liver failure, uncontrolled bleeding, and bladder cancer. Some prescription drugs have been linked to patient deaths.
Several pharmaceutical drugs that have come under recent scrutiny include:
Manufactured by GlaxoSmithKline, Zofran® (ondansetron) was approved to treat nausea during chemotherapy and following surgery. Zofran works by blocking serotonin in the areas of the brain that trigger nausea and vomiting. Between 2002 and 2004, GSK began promoting Zofran off-label for the treatment of morning sickness during pregnancy, despite the fact the drug has not been approved for pregnant women and there have been no well controlled studies in pregnant women.
The FDA has received over 500 reports of serious birth defects linked to Zofran. Birth defect risks include cleft palate and septal heart defects.
Approved in March 2013, Invokana® (canagliflozin) is an SGLT2 Inhibitor used to treat adults with Type 2 diabetes, manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. SGLT2 inhibitors work by preventing high blood sugar by helping the patient’s kidneys remove excess sugar through their urine.
In May 2015, the U.S. Food and Drug Administration (FDA) issued a warning the drug has been lined to cases of ketoacidosis, a serious condition where there is too much acid in the blood. Complications of diabetic ketoacidosis include difficulty breathing, nausea/vomiting, abdominal pain, confusion and unusual fatigue or sleepiness. The condition can lead to diabetic coma and/or death.
Xarelto has been linked to serious side effects including internal bleeding, gastrointestinal bleeding, brain bleed, and death.
Xarelto already carries a black box warning for an increased risk of blood clots with premature discontinuation of therapy, and a risk of epidural or spinal hematomas resulting in long-term or permanent paralysis in patients treated with Xarelto receiving neuraxial anesthesia or undergoing spinal puncture. Black box warnings are the most serious type of warning issued by the FDA, and indicate drugs that carry a significant risk of serious or life-threatening adverse effects.
A University of Massachusetts study found a potential link in postmenopausal women, particularly those who had a Body Mass Index (BMI) less than 25. Of the 153,840 women evaluated, more than 10,000 had developed Type 2 diabetes by the end of the study.
Within the first 14 months of its approval, Pradaxa was linked to more than 900 gastrointestinal bleeds and 500 bleeding deaths. Boehringer, in an official statement on November 2, 2011, linked about 50 bleeding deaths to Pradaxa, which Boehringer asserted is consistent with expectations from the Pradaxa clinical trials.
It is occasionally prescribed to treat attention deficit hyperactivity disorder (ADHD) in children, however this use is not approved by the FDA. Some doctors have also prescribed Risperdal for anxiety, anger management and dementia, which are also off-label uses.
Risperdal side effects include hyperglycemia, dyslipidemia, and weight gain, which can increase the risk of type-2 diabetes. In some cases, patients taking Risperdal have developed extremely high blood sugar that resulted in coma or death.
The latest Risperdal side effect in children is even more troubling. Researchers believe the drug may increase levels of prolactin, a hormone that enables women to produce milk after they give birth. In boys and young men, this can have detrimental effects. Symptoms of gynecomastia include tender and painful breasts, nipple discharge, and breast tissue development which is sometimes uneven. Not only are the symptoms uncomfortable, they can be embarrassing, causing emotional and psychological problems.
Johnson & Johnson’s Janssen Pharmaceuticals faces hundreds of Risperidal lawsuits alleging executives knew Risperdal could cause boys to grow female breasts but actively hid those risks from doctors and patients.
If you feel you have a claim involving a drug that caused serious, unexpected complications, you may be entitled to compensation. Contact us today for a free, no-obligation legal consultation.
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