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.

The U.S. Food and Drug Administration (FDA) recently announced that AndroGel manufacturers would be required to add heart attack and stroke risks to the drug’s warning label, but AndroGel lawsuits are already underway.

Lawyers began filing testosterone lawsuits last year on behalf of men who suffered a heart attack or stroke while taking prescription testosterone. There are 14 manufacturers in the two-billion-dollar market. In June 2014, a centralized Testosterone multidistrict litigation (MDL) was established in Chicago so that testosterone lawsuits involving all 14 manufactures could be filed in one place. Continue Reading

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.

A U.S. Food and Drug Administration (FDA) advisory panel voted overwhelmingly to impose new restrictions on testosterone drugs. The Panelists recommended on September 14th that the agency tighten labels and limit testosterone drugs to men with serious health conditions, such as pituitary gland problems.

More than 2.3 million men are taking testosterone drugs, but only a small percentage is treating a serious medical condition, according to the FDA. The majority of men taking testosterone drugs to treat low testosterone (Low-T) are treating symptoms brought on by aging, such as low energy and libido. Medical experts believe this alarming pattern is due to vague labeling, reported the New York Times.

If the FDA adopts the panels recommendations, the agency would not only tighten the criteria for Low-T prescriptions but would also clamp down on what panelists believe to be inappropriate marketing.

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.

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