Defective Pharmaceuticals

What is Arthritis?

Data from the Centers for Disease Control and Prevention (CDC) shows just how prevalent arthritis is as a medical condition, affecting the lives of over 50 million people all over the United States. According to their findings, almost half of adults aged 65 and older have reported being diagnosed with some kind of arthritis during the years 2010 to 2012.

While arthritis is popularly believed to be a specific disease affecting the joints, it’s actually a group of different types of related conditions differentiated by how they cause joint damaged in the body. The two main kinds of arthritis are osteoarthritis and rheumatoid arthritis. The first kind causes damage to the joint’s cartilage, while the second refers to arthritis caused by damage to the synovial membrane which protects and encloses the inner surfaces of a joint’s capsules.

Regardless of the specific kind, arthritis can be caused and worsened by several risk factors, the most significant of which is age. The CDC has found that around 62% if adults living with arthritis are 65 years and older. In some cases, arthritis can be caused by genetic predisposition, meaning that people with a family history of the disease are more likely to develop some form of the disease. Other factors that increase a person’s risk to developing arthritis are obesity and any previous joint injuries due to accidents.

Despite its commonality, arthritis can be a difficult condition to deal with. Patients with severe cases of arthritis suffer from extreme pain and difficulty moving. While most patients can experience relief and comfort from medication and physical therapy, some might have joint damage that is so severe it needs to be remedied through surgery. These patients get their damaged joint removed and replaced with implants through a procedure called joint replacement surgery. This surgery is typical for replacing damaged knees and hips, as well as defective shoulder replacement.

Joint replacement surgery has many advantages, but it also comes with certain risks. These risks can be particularly dangerous if the implants used during the procedure are found to be defective due to pharmaceutical errors. These defects can cause metal toxicity and bone and tissue damage. It can also cause the implants to degenerate faster than is typical, as well as cause them to dislodge suddenly. Considering these risks, patients are advised to take active part in their treatment plans and have honest conversations with their physicians regarding their specific concerns.

Read More

Internal Bleeding – A Common Deadly Effect of Modern Anticoagulants

In the US, Rivaroxaban, an anticoagulant or blood-thinning drug, is sold under the generic name Xarelto. Its manufacturers, Johnson & Johnson’s subsidiary Janssen Pharmaceuticals and Bayer Health Care, intended this prescription as an alternative to Warfarin, which has been in the market since 1954, and as a competitor to Pradaxa, which gained FDA approval in 2010.

Xarelto was approved by the US Food and Drug Administration in 2011 for patients recuperating from a surgery on the knee and hip replacement surgery, and for those suffering from atrial fibrillation, which is irregularity in heartbeat, pulmonary embolism, which is blood clotting in the lungs, and deep vein thrombosis or DVT, a condition wherein blood clots form in deep veins, typically in the legs.

To prevent blood from clotting, Xarelto slows down the production of Factor Xa, the necessary protein that enables thrombin to form (a thrombin is blood plasma enzyme that causes blood clotting). This capability makes Xarelto (and Pradaxa) the first types of direct thrombin inhibitor (DTI) drugs approved by the FDA.

New generation blood thinners, however, have been found to cause severe internal bleeding, their most dangerous, and often deadly, adverse effect. But in the case of Xarelto, bleeding is more serious, besides the fact that there is no available medication to reverse it (unlike the bleeding due to Warfarin, which can be altered by Vitamin K). Some of the other side-effects linked to Xarelto include the paralyzing spinal or epidural hematoma, stroke, heart-related illness, prolonged bleeding after a cut, frequent nosebleeds, brain hemorrhage, bleeding gums and heavy periods.

Millions of unsuspecting individuals in the US are prescribed with Xarelto every year, not even being informed of the risks they will be subjected to if they use the drug. Being made to suffer an injury that they do not deserve is too much injustice for them and their family.

Read More

Antidepressant Drug Zoloft

Zoloft (generic name Sertraline) is one of the many types of SSRI’s that are given to adults who suffer from major depressive disorders and for both adult and children with panic and anxiety disorders as well as OCD. It comes second among the most-prescribed antidepressants in the United States. Zoloft has pretty much the same contraindications and side effects as other SSRIs, namely insomnia, dry mouth, lower libido and poor sexual performance, nausea, dizziness, and headaches. It also poses the same risks of birth defects for babies whose mothers take Zoloft while pregnant or are breast feeding.

Zoloft dosage relies upon the condition that it is prescribed for: factors such as the age, extent of the condition, patient’s medical history, and other elements are to be looked at before being given a Zoloft prescription. In addition, doctors should know about their patients’ other medication since these can be adverse effects to the patient if there will be drug interactions. Zoloft should not be taken with MAO inhibitors, other antidepressant drugs, Warfarin, Pimozide, and Cimetidine because it can cause severe side effects and further health complications.

In order to get the best results from Sertraline (and to avoid complications) you should inform your doctors about issues such as kidney or liver disease, bleeding or blood clot disorders, epilepsy, seizures, bipolar disorder and family history of drug use and suicide. Doctors are required to make regular check-ups, especially to patients who are antidepressant for the the first time, since taking antidepressants can increase thoughts of suicide. Sudden mood changes, increasing degrees of anxiety or panic attacks, or worsening or addition of side effects or other mental conditions should immediately be reported to your doctor. This is particularly important if you are prescribed a new antidepressant or you had a change in dosage.

Read More

Failure to Warn of GranuFlo Dangers

Most of us take our kidneys for granted while their working normally. But because they act as a filter to remove toxins and waste materials from the blood, it can be fatal when it does not do what it is supposed to. In essence, the body is being poisoned from inside out. In order to clean the blood when renal failure occurs, the patient has to undergo dialysis regularly. A dialysis machine is designed to take the place of the kidneys with the use of a neutralizing substance.

GranuFlo (and its liquid counterpart NaturaLyte) is a product developed and marketed by Frenesius Medical Care (FMC) to help in the neutralization process. It increases the capacity of the bicarbonate agent to deactivate the acid that naturally accumulates in the blood. It makes the process more efficient and less bothersome for the patient.

It is expected that those administering the process of dialysis will have to be sufficiently trained and conscientious about the dosages of the cleaning agents as this will have a direct effect on the patient. An over-dosage of any pharmaceutical product is always undesirable, although there are typically margins for error. With GranuFlo, the margin for error was very narrow, especially for patients with a history of cardiac problems.

It seems strange then that FMC would emphasize potential GranuFlo dangers to dialysis centers in their network but neglect to issue the same warnings to other centers that use their product. It was an inexplicable failure, and one that is turning out to be a legal quagmire of liability for the company. Currently, in excess of 500 cases have been filed in multidistrict litigation (MDL No. 2428 In re Fresenius GranuFlo/Naturalyte Dialysate Litigation) after a Class 1 recall by  the Food and Drug Administration made public a suspected pharmaceutical defect in the product. It is alleged that personal injury caused stroke, cardiac problems, and death of patients.

If you or a family member has suffered injury from using Granuflo, you may be eligible for compensation. Contact a product liability lawyer in the area who is experienced in handling defective drug cases to assess your case and discuss legal options with you.

Read More