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Dangerous Drugs

Each year, thousands of serious injuries, including deaths, linked to dangerous drugs are reported to the FDA. When a drug manufacturer's negligence caused these injuries, we have a proven track record of standing up for the people victimized by these dangerous drugs.

Invokana

Invokana® and SGLT2 Inhibitors »

We are currently investigating and evaluating amputation and/or Fournier’s Gangrene associated with the use of Sodium Glucose co-transporter 2 (SGLT2) drugs Invokana®, Farxiga®, and Jardiance® prescribed to treat Type 2 diabetes. SGLT2 Inhibitors are designed to treat diabetes by targeting the kidneys and promoting the excretion of glucose through urine. This mechanism of action works independently of the body’s supply of insulin. By blocking (inhibiting) a key transport protein that is active in renal filtration, SGLT2 Inhibitors cause glucose to be excreted in the urine rather than allowing it to re-circulate throughout the body. In 2017 the FDA issued a Drug Safety Communication confirming that patients taking Invokana®, as well as Invokamet® and Invokamet® XR, are at an increased risk of leg and foot amputations and that the manufacturers (Johnson & Johnson and its subsidiary Janssen Pharmaceuticals) must include a “Black Box Warning” on the drugs’ labeling. The Drug Safety Communication was issued after the FDA reviewed data from two different clinical trials – the CANVAS and CANVAS-R studies. These data demonstrated that diabetes patients treated with Invokana®, Invokamet® and Invokamet® XR were twice as likely to require leg and foot amputations than those diabetes patients who were taking placebo (a non-drug).

On August 29, 2018 the FDA issued an urgent Safety Announcement to health care professionals and their patients. The Alert warned about the association between Invokana®/Invokamet®/Invokamet® XR, Jardiance, Farxiga and other SGLT2 diabetes medications and Fournier’s Gangrene, a life-threatening genital infection that can affect both men and women.

Valsartan Box

Valsartan »

We are currently investigating and evaluating acute liver injury and/or liver or other types of cancer associated with the use of valsartan-containing drugs. Valsartan belongs to a class of drug identified as angiotensin receptor blockers (ARBs) which are designed to prevent the constriction of blood vessels – a process that increases blood pressure. Angiotensin is produced by the body and, when it attaches to angiostenin receptors, the result is a narrowing (constricting) of the blood vessels. Valsaratan, because it blocks angiotensin from attaching to the receptors, prevents the blood vessels from narrowing. By this action, valsartan acts as a vasodialator which reduces blood pressure. In 2018 the FDA announced a voluntary recall of several medications that contain valsartan. The recall was initiated after the discovery of the presence of a contaminant N-nitrosodimethylamine(NDMA) in the recalled drugs. NDMA is classified as a probable human carcinogen which means that it is more likely than not to cause cancer in humans. The studies have raised the specter of an association between NDMA and liver toxicity which can lead to the development of liver cancer and other related conditions brought about by an NDMA-induced “insult” to the liver. NDMA is also believed to be associated with intestinal, colon, rectal, stomach, renal, pancreatic, and bladder cancer.

Pradaxa

Pradaxa® »

We are currently investigating and evaluating bleeding injuries associated with the use of Pradaxa®, an anti-clotting medication initially approved by the FDA to prevent the formation of blood clots that can lead to stroke and systemic embolism in patients with atrial fibrillation not caused by cardiac valve deficiencies. Atrial fibrillation, or A-Fib, as it is commonly known, occurs when the atrial chambers of the heart (the smaller, upper chambers) beat in an irregular fashion so that they are rhythmically out of sync with the lower, larger chambers of the heart – the ventricles. A-Fib can be caused by numerous conditions. Pradaxa® has also been approved to prevent the development of blood clots, deep vein thrombosis (DVT) and pulmonary embolisms (PE) in patients who have undergone hip replacement surgery and to reduce the risk of recurrence of DVT and PE in patients who were previously treated.

Xarelto

Xarelto® »

We are currently investigating and evaluating bleeding injuries associated with the use of Xarelto®, an anti-clotting medication approved to: (1) prevent the formation of blood clots in patients with atrial fibrillation not caused by cardiac valve deficiencies; (2) prevent deep vein thrombosis in patients having knee or hip replacement surgery; and (3) to prevent pulmonary embolism. We are currently investigating and evaluating bleeding injuries associated with the use of Pradaxa®, an anti-clotting medication approved to prevent the formation of blood clots in patients with atrial fibrillation not caused by cardiac valve deficiencies. Atrial fibrillation, or A-Fib, as it is commonly known, occurs when the atrial chambers of the heart (the smaller, upper chambers) beat in an irregular fashion so that they are rhythmically out of sync with the lower, larger chambers of the heart – the ventricles. A-Fib can be caused by numerous conditions.

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