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® is approved by the U.S. Food and Drug Administration (FDA) for six indications including reducing the risk of stroke in patients with non-valvular atrial fibrillation; treating deep vein thrombosis and pulmonary embolism, and reducing the reoccurrence of these conditions; and preventing blood clots in patients following knee or hip replacement surgery.

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.

Byetta® and Januvia® are two drugs used to treat Type 2 diabetes. The FDA approved Byetta in 2005 and Januvia in 2006. These drugs have been prescribed to millions of people in the United States. Since approving the medications, the FDA has issued several warnings about links between Byetta and Januvia to complications related to pancreatic diseases. Recent studies have linked these two drugs to acute pancreatitis and pancreatic cancer. We are currently investigating claims of pancreatic cancer.

Lipitor®, a statin drug to treat high cholesterol, was approved by the FDA in 1996 and is one the best-selling prescription medications in the world. Recent studies have found a possible link between Lipitor and the risk of developing Type 2 diabetes.

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.

Approved by the FDA in October 2010, Pradaxa® (dabigatran) is marketed by Boehringer Ingelheim Pharmaceuticals, Inc., to reduce the risk of strokes and blood clots in people who have atrial fibrillation, a common heart rhythm abnormality. Pradaxa is in a class of anticoagulant medications known as “blood thinners.”

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.

Risperdal®, also known by its generic name risperidone, and Invega®, also called paliperidone, are atypical anti-psychotics that change the effect of brain chemicals. They are approved by the Food and Drug Administration (FDA) to treat adults, adolescents and children with schizophrenia, bipolar disorder, and irritability in people with autism.

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.

Testosterone Replacement Therapy (TRT) products for men have been linked to an increased risk of death, heart attack, and stroke. Researchers found men who used testosterone therapy were 30 percent more likely to have a heart attack, stroke, or die after three years of use.