Ocella Venous Thromboembolism Lawsuit

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In April 2012, the U.S. Food & Drug Administration (FDA) ordered that warning labels of Ocella and other drospirenone-based contraceptive products be updated to include information about an increased risk of blood clots. The term ‘venous thromboembolism’ (VTE) refers to a clot that develops in the deep veins (usually the legs) which breaks away and migrates through the circulatory system into the lungs. Signs and symptoms of an Ocella-induced venous thromboembolism may include shortness of breath, pleuritic chest pain, increased breathing rate, and coughing up blood.

What’s the Problem with Ocella?

Ocella, a generic version of Bayer’s blockbuster birth control pill Yasmin, is a synthetic analogue known in the medical world as drospirenone. Because of Ocella’s ability to manipulate hormones in the body, many users have have reported severe side effects and long-term health complications after taking the drug. One of the most serious side effects to be linked to Ocella is a type of blood clot known as a venous thromboembolism (VTE).

Venous Thromboembolism Overview

Venous thromboembolism is a common medical condition caused by the formation of a blood clot (thrombus) within a vein that may lead to partially or completely blocked circulation. A classical VTE consists of a deep vein thrombosis (DVT) that breaks off (embolizes) and becomes a life-threatening pulmonary embolism (PE). The conditions of DVT and PE are collectively referred to as venous thromboembolism.

Signs & Symptoms

Although most nurses are trained to look for swelling in the arms or legs, many cases of venous thromboembolism do not present this way. Telltale symptoms of VTE may include:

  • pain upon quick dorsiflexion of the foot (Homan’s sign)
  • shortness of breath
  • pleuritic chest pain
  • increased breathing rate
  • coughing up blood

However, some VTEs may have no signs or symptoms at all, and the patient may just go into cardiac arrest. This is why prevention is the most important step in treating venous thromboembolisms.

Treatment & Prevention

Fortunately, there are a number of interventions that can be performed to prevent venous thromboembolisms. Early ambulation following surgery is critical in mobilizing blood in the legs to prevent clots. Turning and positioning immobilized patients regularly can also help avoid a VTE event. Additionally, elastic compression hoses and sequential stockings can help massage the legs and keep blood flowing to prevent VTEs from forming.

Once venous thromboembolism has been diagnosed, the main course of treatment typically involves intravenous heparin or subcutaneous low-molecular-weight heparin, followed by an oral anticoagulant such as Coumadin (generic: warfarin) to prevent embolization and recurrences. The optimum dosage and duration of therapy is largely dictated by underlying risk factors.

Ocella Side Effects

Unfortunately, venous thromboembolisms are not the only serious side effect reported by Ocella users. The following complications have also increasingly been associated with Ocella and other drospirenone-containing birth control pills:

  • Heart Attack
  • Cardiac Arrhythmia
  • Stroke
  • Kidney Failure
  • Seizures
  • Blood Clots
  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Gallbladder Disease
  • Hepatic Adenoma
  • Sudden Death
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