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Diabetic Med Actos® Faces Malpractice and Product Liability Lawsuits

July 23, 2014

Diabetes is one of the most common debilitating diseases in the U.S. today, and according to the National Diabetes Education Program (NDEP), an estimated 25.8 million Americans suffer from either Type 1 or Type 2 diabetes.  However common, the disease is one of the least discussed conditions to affect so many people.  In fact, the NDEP reports that an estimated 7 million people with the disease are not aware that they have it.  Nearly 2 million people are diagnosed with the disease annually.

The two most common types of diabetes are Type 1 and 2.  Type 1 was previously identified as early-onset or juvenile diabetes.  Type 2 is by far the most common, and accounts for approximately 90 to 95 percent of all diagnoses.  There is no cure for either type of diabetes, though studies have proven that regular exercise and weight loss can help prevent or delay the onset of the disease for many people.  Despite these easy ways to help mitigate the effects of diabetes, the disease still costs the nation an estimated $116 billion in direct medical costs (such as hospitalizations, medical care, and treatments) every year. 

A flood of recent lawsuits have been filed regarding injuries sustained from Actos, a popular drug prescribed to millions of Americans with Type 2 diabetes that is meant to control blood sugar.  The drug, reported by DrugWatch, is linked “to serious, life-threatening side effects, including heart failure and bladder cancer.”  Lawsuits brought against the manufacturers of the drug allege that they failed to warn both patients and healthcare providers of the dangerous side effects, failed to properly test the drug before marketing it to the public, and “concealed testing and research data from the public,” according to DrugWatch.com.

SSRI Drugs Linked to Septal Heart Defects

July 22, 2014

Several years ago reports were released regarding antidepressant medications and the link to birth defects.  Studies have shown that women who take antidepressants during pregnancy may risk that their baby will have a heart defect.  And the risk of the baby being born with a defect is greater when the used antidepressant is a selective serotonin reuptake inhibitor (SSRI).  The same goes for moms who switch to an SSRI antidepressant medication early in the pregnancy.  Many women experience hormonal changes during pregnancy are prescribed antidepressants as a result.  However, it was not clear in past studies if all SSRI medications led to the increased risk of heart defect.

In 2005, the U.S. Food and Drug Administration (FDA) issued warnings about Paxil, an antidepressant similar to the more widely used Zoloft, Celexa, or Prozac.  The study found no link between heart defects in babies whose mothers were taking Prozac or Paxil.  But, it did find a connection in mothers taking Celexa or Zoloft.  That study, which examined more than 400,000 babies between 1996 and 2003, found that “septal heart defects occurred in 0.5 percent of children born to mothers who did not take antidepressants and 0.9 percent of children born to mothers who did.”

Septal heart disease is when a hole occurs between the heart’s chambers.  According to the National Heart, Lung, and Blood Institute (NIH), the hole changes the normal flow of blood through the heart, which can result in several complications throughout life.  While it used to be a life-threatening condition (and it is still considered severe), children who now have a hole in their heart tend to live on to adulthood. Some, according to the NIH, can “live normal, active lives because their heart defects close on their own or have been repaired.”

Currently, the FDA “states that effects on unborn humans remain unproven.”  As a result, the FDA has issued a safety grade “C” to the practice of taking SSRIs while pregnant, but has not banned the practice or made it more difficult for doctors to prescribe to pregnant women. Only Paxil carries a grade “D,” which means that it has been proven to cause harm to a human fetus.

Investigations Into Wrongful Deaths After Using Xarelto®

July 18, 2014

Xarelto® (rivaroxaban) is in a class of drugs called "New" Oral Anticoagulants (NOACs).  These "new" class of drugs were created to be the next generation of blood-thinning drugs and replace Coumadin (warfarin) which has been used for more than 50 years by the healthcare industry.  Coumadin must be monitored by medical doctors to ensure the patients blood levels are balanced.  In the event the patients blood levels are not balanced the doctor can prescribe an antidote to balance the blood levels out.  If the blood level are not balanced appropriately the patient can experience internal bleeding and suffer a stroke.

More and more patients are claiming to have been injured by the controversial blood thinning drug Xarelto.  Bayer and Johnson & Johnson are the manufacturers of Xarelto which has been linked to patients bleeding to death or having other major side effects.  Not only has it been alleged that patients weren't warned about the ongoing FDA safety concerns, but doctors were left in the dark as well.   Xarelto manufacturers Bayer and Johnson & Johnson are being accused of withholding vital information concerning its safety.

Drug manufacturers Bayer and Johnson & Johnson, claim minimal to no monitoring is necessary with Xarelto; although, expert investigations have shown the opposite to be true.  Patients benefit from having their blood levels measured to ensure the medication is working properly.  Patients with too high of a concentration level of Xarelto in their system are up to five times more likely to suffer a deadly internal bleed than those with low blood concentration levels.  Therefore, it's safe to simply have the patient's blood tested during the course of treatment.  The major problem is if the blood levels are not balanced, there is no anticoagulant or antidote to balance out the blood.  This leads to more internal bleeding and even death.


Internal Bleeding Caused by the New Blood Thinner, Xarelto®

July 16, 2014

Xarelto® (rivaroxaban) is an anticoagulant or a blood thinner given to patients whose blood is at a risk of clotting.  Xarelto blood thinner is manufactured by Bayer and Johnson & Johnson.  Both companies have been accused of misleading consumers and marketing Xarelto as a safe drug; yet, not being forward about the lack of an antidote.  It is necessary for blood in the body to stay at a certain thickness and this is determined by measuring the blood levels in the patient.  When something interferes with the bloods ability to clot, such as using Xarelto, the patient runs the risk of the drug working too well.  In this worst case scenario, the body can then experience excessive internal bleeding and may cause death, if not controlled immediately.  Bleeding can be either external or internal.  In the case of Xarelto, some of the biggest concerns are the risks of serious internal bleeding.  These include:

●       Uncontrolled internal bleeding

●       Bleeding in the intestines

●       Hemorrhaging of blood in the brain

●       Bleeding from the rectum

In May 2012, an FDA panel recommended against expanding use of the anticoagulant Xarelto because "concerns over dangerous bleeding outweighed evidence that the drug helped reduce the risk of blood clots in patients with serious heart problems."  Direct recommendations were made such as the drug not be used in patients with acute coronary syndrome.  This condition occurs in patients when a blood clot blocks a vessel leading to the heart, depriving the heart muscle of the oxygen it needs.

A major concern is the fact that Xarelto can cause severe, life threatening internal bleeding; yet, there is no anticoagulant to help those that have such a side effect.  Patients were not previously warned about this prior to taking the medication and some have bleed to death.  Doctors are still looking for a way to stop the bleeding once it starts.  The potential for uncontrollable bleeding makes XArelto a dangerous drug.  Some healthcare providers are expressing concern over the safety of the drug, but it continues to be one of the most commonly prescribed anticoagulants on the market.


What are Negative Side Effects of Xarelto® (Rivaroxaban)?

July 14, 2014

Xarelto® (rivaroxaban) is one of the newest anticoagulants on the market.  Since it received FDA approval in July 2011, it has quickly become one of the most popular drugs in its class, mainly because it requires far less restrictions than its competitor ‘Warfarin’.  Xarelto was first approved to reduce the risk of blood clots, deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip or knee replacement surgery. Then in November 2011, it was also approved to reduce the risk of stroke in patients with atrial fibrillation and for the general treatment of DVT and PE.

The most serious and dangerous side effects of the anticoagulant medication Xarelto is internal bleeding that cannot be controlled.  As with all blood thinners, Xarelto has the potential to increase a patient's risk for internal bleeding.  The danger with this specific medication; however, is that there is no cure or treatment to stop internal bleeding once it starts.  The intense internal bleeding significantly increases the risk of death by uncontrollable bleeding.

If you or a family member are taking Xarelto, tell your doctor immediately if you experience any of the following symptoms of internal bleeding:

●       Frequent nosebleeds

●       Unusual bleeding from the gums

●       Heavy vaginal bleeding

●       Red, pink or brown urine

●       Bright red or black stools

●       Vomiting blood

●       Coughing up blood

●       Dizziness, headaches

Other very serious side effect and even fatal side effects associated with Xarelto usage include:

●       Abnormal liver function

●       Abdominal bleeding

●       Brain hemorrhage

●       Reduced platelet levels

Hughes and Coleman represent injury victims who have been prescribed Xarelto, and suffered severe side effects from Xarelto, including severe bleeding.  Our medical malpractice and product injury lawyers represent injury victims in the Bowling Green, KY and Nashville, TN areas.