Articles Posted in Unsafe Drugs

On May 16, 2017, the FDA concluded that the Type 2 diabetes medication Canagliflozin (Invokana, Invokamet and Invokamet XR) causes an increased risk of leg and foot amputations. The FDA will now require the most prominent black box warning to be added to the Canagliflozin drug labels. This new warning came at the conclusion of two large clinical trials, one of which showed that leg and foot amputations occurred about twice as often in patients treated with Canagliflozin versus a placebo.

The Unsafe Drug and Medical Device Team at Anapol Weiss is investigating Canagliflozin cases on behalf of patients who have suffered an amputation. In the event you receive any calls regarding these products, we welcome the opportunity to work with you and your clients.

Xarelto is a blood thinner medication prescribed for patients with atrial fibrillation and those prone to life-threatening blood clots such as pulmonary embolism. But if a person sustains an injury that causes serious internal bleeding, there is no antidote to reverse Xarelto’s effects. Some patients have bled to death as a result.

Xarelto users were not advised to monitor their blood levels while taking the drug, and it only takes one dose to cause significant and irreversible internal bleeding after an injury. Victims and their families have begun to file Xarelto lawsuits to make manufacturers Bayer HealthCare Pharmaceuticals, Janssen Pharmaceuticals and Johnson & Johnson take responsibility for a traumatic and deadly complication they didn’t know could happen.

In January 2014, the U.S. Food and Drug Administration (FDA) announced that it would investigate the side effects of testosterone drugs. The FDA’s announcement came on the heels of a study that suggested that men who take testosterone drugs have an increased risk of adverse cardiovascular events such as a heart attack or stroke.

Men taking testosterone should talk to their doctor about the risk of suffering a stroke while using testosterone and should be aware of the following signs of a testosterone stroke:

• Numbness or weakness in your face, arm, or leg, especially on one side • Confusion or trouble understanding other people • Trouble speaking • Trouble seeing with one or both eyes • Trouble walking or staying balanced or coordinated • Dizziness • Severe headache that comes on for no known reason

One unfortunate side effect for some men and boys who took Risperdal is male breast growth called gynecomastia. Risperdal gynecomastia victims are left bear the burden of Risperdal side effects physically, emotionally and financially.

There is no easy way to treat gynecomastia. The only way to completely fix the problem is by undergoing gynecomastia surgery, which can be expensive. In fact, the average cost of gynecomastia surgery is more than $3,000, according to the American Society of Plastic Surgeons.

Patients and their families are often left to bear the financial burden of gynecomastia surgery costs, because the procedure isn’t often covered by insurance.

Boys and young men who use the antipsychotic drug Risperdal may be at an increased risk of developing gynecomastia, a condition that involves abnormally large breast growth in males.

Gynecomastia usually requires a mastectomy or liposuction to remove unwanted breast tissue. But until that can happen, victims are left to suffer with this visible and embarrassing Risperdal side effect. The situation can leave a young person with permanent physical and emotional scars, and that isn’t right.

Families are now filing Risperdal lawsuits to make the drug manufacturer take responsibility for its failure to warn them about Risperdal gynecomastia. Each state limits the amount of a time a person has to file suit, so victims are urged to contact the Anapol Weiss law firm to protect their legal rights.

Acetaminophen taken during pregnancy may be linked to the development of attention deficit hyperactivity disorder (ADHD) in children, according to a preliminary study from Denmark.

Experts say the study does not prove a cause-and-effect relationship and more research is needed. It is likely to prompt concerns among women who were told Tylenol and other acetaminophen-based drugs are safe during pregnancy.

The study examined the medical records of more than 64,000 Danish children born from 1996 to 2002. The researchers looked for a possible link between acetaminophen and ADHD because they believe the drug may be a hormone disruptor capable of affecting fetal brain development. Researchers tracked children through questionnaires parents completed when children were 7 years old as well as diagnoses of “high-end” ADHD called hyperkinetic disorder, and ADHD medication prescriptions.

The U.S. Food and Drug Administration (FDA) is investigating the risk of cardiovascular events including death, stroke and heart attack in men who use prescription testosterone drugs.

An observational study published in November 2013 prompted the FDA to investigate the connection between testosterone drugs and heart problems. The research suggested a 30 percent increased risk of death, stroke and heart attack in men prescribed a testosterone therapy drug.

Another study published in January 2014 reported a two-fold increased risk of heart attack during the first 90 days of use by men over 65 and younger men with a history of heart disease.

Some people — especially people needing certain drugs to prolong their lives or end severe pain – think that the FDA drug approval process is slow and tiresome. According to a recent study, the FDA approves drugs faster than either Canada or Europe. Does this surprise you?

Is that good news or bad news?

The Prescription Drug User Fee Act (PDUFA) of 1992 was passed to expand the FDA resources devoted to reviewing applications for novel therapeutics for humans and to ensure drug safety. The FDA is able to collect user fees for each new drug application in order to support what is needed as part of the review process. Nevertheless, performance standards have been associated with higher rates of black box warnings and drug withdrawals.

In December 2007, New Jersey mother of two, Jackie Bozicev collapsed one morning on her way to the shower. Her husband called 911, and the EMT’s did whatever they could to revive her based upon what little information they had about the problem, but Jackie, just 32 years old was dead before they reached the hospital.

To unravel the mystery of her death, and autopsy was performed, and the M.E. determined that Mrs. Bozicev died of a blood clot that started in her pelvic area and migrated up to her lungs.

Prior to her sudden death, Jackie had been perfectly healthy. Her husband, Rob, did what any of us would do after losing a loved one to a sudden illness. He conducted research. As stated in a 2009 article “Is NuvaRing Dangerous” Rob believes that his wife’s death was caused by her birth control method, the NuvaRing. Rob retained an attorney to file a complaint against the ring’s manufacturers, Organon, and Schering-Plough, who are now a part of Merck.

Rob’s Story was published on in 2009. At that time there were about 100 Federal Lawsuits pending against the manufacturers of NuvaRing. As of June 2011, there were about 900 lawsuits. The amount of clams increased by 9 times in two years. These lawsuits were filed by people who, like Rob, did some research. What about all of the people out there who did not think to research their medical mysteries? After all, aren’t blood clots a known risk of birth control. Are many victims simply believing that are within the small percentage of cases that these injuries do occur? Is there something special in NuvaRing that makes them more likely to suffer these potentially fatal side effects? If so, why isn’t there a warning?
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Earlier this month, major media outlets reported that researchers at George Washington University found problems with the use of Propecia for male pattern baldness. Of the 54 men under 40 years old, a whopping 96% of the men experienced sexual dysfunction after months of stopping the Propecia.

The reason men took Propecia was to look and feel sexier and more desirable. Now Propecia has played a cruel joke on them. Men reported a variety of sexual problems including diminished libido, trouble achieving orgasm, erectile dysfunction, and painful and shrinking genitals. Some men also reported anxiety, cognitive haziness, and depression.

On April 11, 2012, the FDA announced changes to the professional labels for Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) to expand the list of sexual side effects reported as some of side effects had been reported to continue after the drug was discontinued.

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