What is Onglyza?

Onglyza (saxagliptin) is a diabetes drug sold by AstraZeneca and Bristol-Myers Squibb, and commonly prescribed with diet and exercise to help control high blood sugar in adults with Type 2 diabetes. Onglyza was approved by the U.S. Food and Drug Administration (FDA) in 2009, and in 2014 alone, the medication brought in $820 million in sales for AstraZeneca and Bristol-Myers Squibb. The diabetes medication belongs to a class of drugs called DPP-4 (dipeptidyl peptidase-4) inhibitors, which are designed to help the pancreas secrete more insulin and inhibit the liver from making excess sugar.

Alleged Onglyza Side Effects

Since they first entered the market, DPP-4 inhibitors like Onglyza have been widely prescribed in the United States, and touted as the “new darlings of diabetes treatment.” However, serious concerns have emerged recently about the potential for Onglyza to cause severe side effects in users, including possibly increasing the risk of the following:

• Pancreatitis
• Pancreatic cancer
• Heart failure
• Severe joint pain
• Wrongful death

Studies Linking Onglyza to Side Effects

It wasn’t until 2011 that information about the risk of pancreatitis was added to the Onglyza warning label, after the FDA received post-market reports of patients suffering acute pancreatitis after taking the diabetes medication. Unfortunately, during the two years that Onglyza was on the market before that FDA warning was issued, Type 2 diabetes patients continued taking the DPP-4 inhibitor, unaware of the potential for the prescription drug to cause pancreatitis, a serious condition characterized by inflammation of the pancreas that can lead to hospitalization, pancreatic cancer and death.

In one study published in 2013, researchers found pre-cancerous cells in the autopsied pancreases of individuals taking incretin-based medications like Onglyza, and indicated that the use of DPP-4 inhibitors may be linked to the production of abnormal beta cells in the pancreas, as well as the development of small, benign tumors called adenomas that can become malignant. In another 2013 study, researchers found a possible connection between Onglyza treatment and an increased risk of heart failure, occurring when the heart pumps blood at a slower-than-normal rate, depriving the body of the oxygen it needs to survive.

In April 2015, an FDA panel recommended that new warnings be added to the Onglyza label regarding the potential increased risk of heart failure, citing data from the SAVOR clinical trial, which involved 16,492 patients and found that those taking Onglyza faced a 27% higher risk of heart failure hospitalizations, compared to the control group. Later that same year, the FDA issued a safety announcement warning that “the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling.”

Contact our experienced Onglyza legal team today

Hundreds of lawsuits have already been brought against the makers of Type 2 diabetes drugs like Onglyza, in connection with pancreatitis, pancreatic cancer, heart failure and other side effects, and more complaints are expected to be brought in the future, as more and more consumers become aware of the potential for Onglyza to cause devastating complications in users. If you have suffered pancreatitis, pancreatic cancer or another major medical complication, and you believe Onglyza to be the cause contact the Monroe Law Group today.

Alert: Due to statute of limitations, the time you have to pursue a claim is limited. Call us right away at 866-308-1092, email us at intake@monroelawgroup.com, or complete the form on this page now.

• Testosterone lawsuits are being filed due to dangerously high links to complications including heart attacks, strokes, pulmonary embolism, blood clots and death
• Attorneys believe that the manufacturers were aware of these links but continued to aggressively marketing these products in a case of profits over lives.
• Financial compensation may be available if you or a loved on has used one of these drugs and suffered an injury.

Otherwise healthy men who use testosterone therapies like AndroGel and Testim may be at risk for serious and potentially life-threatening medical consequences, like heart attack, stroke, blood clots and pulmonary embolism.

Unfortunately, because the makers of these medications have allegedly failed to provide adequate warnings about the risk of side effects from low-T treatments, men across the country with no medical need for testosterone therapy are putting themselves at an unnecessary risk for major complications by taking the drugs.

If you used a low-T treatment in the past, and you have since suffered a heart attack, stroke, or another serious medical condition, consult an experienced testosterone therapy attorney today to explore your possible compensation options.

Monroe Law Group – NO FEES UNLESS YOU WIN. You pay nothing until you win your case. Monroe Law Group pays for all costs of the lawsuit up front, and if don’t win, you pay nothing! If we win, you pay a percentage of the awarded settlement. Call 866-308-1092 now to speak with our team at no cost and no obligation.

What is Testosterone Replacement Therapy

Testosterone replacement therapy (TRT), also sometimes called testosterone therapy or “low-T’ treatment, is a type of medical treatment designed to help maintain a more uniform level of blood testosterone. Testosterone products like AndroGel, Testim and Fortesta are only approved to treat low testosterone levels in men diagnosed with hypogonadism, a condition occurring when the male gonads fail to function properly, but many healthy men have started testosterone replacement therapy in an effort to reverse the signs of the natural aging process, like erectile dysfunction, fatigue, decreased sex drive and loss of muscle mass. Low-T treatments can be administered in the form of a topical gel, a transdermal patch, an injection or the buccal system (applied to the inner cheek or upper gum).

Possible Side Effects of Low-T Treatment

Because there is limited data available regarding the safety and effectiveness of TRT for men who lack an associated medical condition, testosterone treatment has not been approved for this use, yet healthy men who have never had their testosterone levels properly tested continue to be prescribed low-T treatments like AndroGel and Testim. What many of these men don’t know, is that testosterone therapy has been linked to a potential increased risk of serious side effects in users, including:

• Heart attack
• Stroke
• Blood clots
• Pulmonary embolism
• Irregular heartbeat
• Deep vein thrombosis
• Decreased sperm production
• Wrongful death

Research Linking TRT to Serious Complications

In one study conducted by the National Cancer Institute in January 2014, researchers found that men over the age of 65, and men younger than 65 with a history of heart disease, had double the risk of suffering a heart attack within three months of starting testosterone replacement therapy. Another study published in the Journal of the American Medical Association in November 2013, found that older men faced a 29% increased risk of heart attack, stroke and death while using low-T treatments, further supporting the alleged link between testosterone therapy and potentially life-threatening side effects in men. It wasn’t until March 2015, that the FDA announced updated warning labels for all testosterone therapy products, highlighting the potential connection between low-T treatments and problems with heart attack and stroke. In the updated safety announcement, the FDA warned that “the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”

Our Experienced Testosterone Therapy Legal Team Can Help

Alert: Due to statute of limitations, the time you have to pursue a Testosterone Therapy claim is limited. Call us right away at 866-308-1092, email us at intake@monroelawgroup.com, or complete the form on this page now.

How Does Xarelto Work?

Xarelto (rivaroxaban) is an anticoagulant medication sold by Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, and used to prevent blood clots from forming in patients with atrial fibrillation or those undergoing knee or hip replacement surgery. Approved by the U.S. Food and Drug Administration (FDA) in 2011, Xarelto has been marketed by its manufacturers as a safer and more convenient alternative to warfarin, a blood thinner that has been on the market for decades. According to Bayer and Janssen, Xarelto is easier to take than warfarin and other older anticoagulant drugs, because it doesn’t require regular checkups or changes in diet and lifestyle during treatment.

What are the Possible Side Effects of Xarelto

Although Xarelto may require less patient monitoring than warfarin, the fact that the new-generation anticoagulant drug does not have an approved antidote makes it considerably more dangerous. Unlike warfarin, whose blood thinning effects can be reversed with a dose of vitamin K, there is no reversal agent for Xarelto, which means doctors may be unable to control internal bleeding complications in patients taking Xarelto, thereby increasing the risk of hospitalization or death. Among the possible side effects associated with Xarelto treatment are:

• Abdominal bleeding
• Internal bleeding
• Brain hemorrhage
• Abnormal liver function
• Gastrointestinal bleeding
• Hemorrhagic stroke
• Wrongful death

Studies Linking Xarelto to Complications

Although Xarelto is designed to prevent blood clots and blood clot-related injuries, adverse event reports submitted to the FDA in connection with Xarelto treatment indicate that patients taking the blood thinner may actually be at an increased risk for blood clots that may trigger heart attacks or strokes if they travel to the brain. In a Phase III study intended to analyze the safety of Xarelto, 73% of the 16,000 patients who took at least one dose of the blood thinner experienced serious side effects, including anemia and bleeding complications. The Xarelto drug label also currently carries a black box warning highlighting the risk of dangerous spinal bleeds called spinal hematomas, which can lead to permanent paralysis.

Researchers have been examining the possible safety risks of Xarelto for years. In 2011, the New England Journal of Medicine published the results of the ROCKET AF study, which compared Xarelto to warfarin in patients with atrial fibrillation. According to the FDA, the study failed to provide adequate evidence that Xarelto is a more effective treatment than warfarin, and the new-generation blood thinner is also known to cause more internal bleeding than its predecessor. In light of the potential for Xarelto cause serious bleeding complications, former Xarelto users across the country are pursuing legal claims against Bayer and Janssen, alleging that the drug makers manufactured a defective drug and failed to adequately warn consumers and doctors about its risks.

Contact our expert Xarelto legal team today for help

Alert: Due to statute of limitations, the time you have to pursue a Xarelto claim is limited. Call us right away at 866-308-1092, email us at intake@monroelawgroup.com, or complete the form on this page now.

How Does Zofran Work?

Zofran (ondansetron) is a prescription anti-emetic medication approved by the U.S. Food and Drug Administration (FDA) in 1991, to relieve nausea and vomiting in patients undergoing chemotherapy or radiation treatment, and the drug is currently manufactured by GlaxoSmithKline. Zofran belongs to a class of drugs called 5HT3 receptor antagonists, and works by blocking a neurotransmitter in the brain called serotonin, which triggers nausea and vomiting. Despite the fact that Zofran has never been approved for use in pregnant women, the anti-nausea drug is commonly prescribed off-label as a treatment for a severe form of morning sickness called hyperemesis gravidarum, which can lead to malnutrition and dehydration. Unfortunately, morning sickness is most common during the early stages of pregnancy, and research shows that pregnant women who take Zofran to relieve nausea and vomiting may have an increased risk of giving birth to babies with severe birth defects.

Alleged Zofran Birth Defects

Due to the increasing popularity of Zofran and similar anti-nausea drugs like Zuplenz, approved in 2010 based on its similarity to Zofran, a number of studies published in recent years have sought to examine the potential adverse effects of Zofran on a developing baby. According to these studies, babies born to women who take Zofran during pregnancy may have a greater risk of suffering debilitating congenital malformations like:

• Heart defects
• Atrial/ventricular septal defects
• Kidney malformations
• Cleft lip
• Cleft palate
• Mouth deformities
• Fetal growth restriction
• Musculoskeletal malformations
• Fetal death

Zofran Birth Defect Lawsuits

A number of recent studies have explored the alleged connections between maternal use of Zofran and devastating birth defects, including one notable study published in the journal Reproductive Toxicology in December 2014, which found double the risk of “hole in the heart” birth defects in babies exposed to Zofran during the first trimester of pregnancy, and a 62% increased risk of birth defects overall. In 2011, a large study conducted by the U.S. Centers of Disease Control and Prevention (CDC) and the Slone Epidemiology Center in Massachusetts, reported a two-times increased risk of cleft palate birth defects among children exposed to Zofran during the early stages of pregnancy, when a developing fetus is most susceptible to harm.

As parents across the country become aware of the potential for Zofran use in pregnancy to interrupt fetal development and cause birth defects in babies, a growing number of Zofran birth defect lawsuits are being filed against GlaxoSmithKline. All of the product liability lawsuits involve similar allegations that GSK failed to adequately warn consumers and medical professionals about the potential for Zofran to cause serious birth defects in babies when used off-label as a treatment for morning sickness in pregnant women. In August 2012, the U.S. Department of Justice filed a complaint against GSK for allegedly marketing Zofran as an off-label treatment for pregnant women, which is illegal, and the drug maker was ordered to pay $3 billion to resolve the claims.

Contact our experienced Zofran legal team today for Help

Alert: Due to statute of limitations, the time you have to pursue a Zofran claim is limited. Call us right away at 866-308-1092, email us at intake@monroelawgroup.com, or complete the form on this page now.