Viagra

  • Viagra Medical Record Review & Outsourcing Services

Viagra (Sildenafil) is a phosphodiesterase inhibitor manufactured by Pfizer and approved by the Food and Drug Administration (FDA) in 1988. It is a drug widely used to treat erectile dysfunctions in men and pulmonary hypertension. Pfizer has two patents for Sildenafil, one is indicated to treat cardiovascular disease and marketed as Revatio which expired in 2012 and another is indicated to treat erectile dysfunction and marketed as Viagra The Viagra patent is expected to expire in 2019 in the US.

A study conducted in 2014 stated that there is an 84% increased risk of melanoma (skin cancer) associated with Viagra while other studies also suggest that it may increase the risk of vision problems like blindness. It is been said that men who use Viagra tend to double the risk of developing Melanoma, the most dangerous form of skin cancer. Some studies have put out the estimates as people dying of Melanoma do have the majority of the male population.

Serious Alleged Injuries may include:

  • Melanoma skin cancer
  • NAION (Non-arteritic Anterior Ischemic Optic Neuropathy)
  • Heart Attacks
  • Strokes
  • Hearing Loss

FDA SAFETY WARNINGS:

  • The FDA ordered a warning to be added to drug's label about vision loss in 2005 and in October 2007, requesting changes in the label to include warnings about sudden hearing loss associated with the drug, when they received 29 reports of patients who experienced sudden hearing loss within hours to two days of taking Viagra.
  • In October 2005, a petition required a black box warning for erectile dysfunction drugs Sildenafil (Viagra), Tadalafil (Cialis) and Vardenafil (Levitra).
  • In 2012, the FDA advised that Revatio (sildenafil) should not be prescribed to children ages 1 through 17 for pulmonary arterial hypertension (PAH), or high blood pressure in the blood vessels leading to the lungs. In 2014, the FDA issued an update and clarification of its earlier recommendation suggesting that it was up to the health care professionals to consider whether the benefits of treatment are likely to outweigh the potential risks to their patients.

Lawsuit Allegations:

The manufacturer of Viagra, Pfizer, failed to adequately warn the consumers about the dangers of NAION and about studies connecting the highly sold drug to increased melanoma risk leading to various defective drug lawsuits.

All federal Viagra lawsuits have been centralized into a Multi-District Litigation (MDL No. 2691) in the U.S. District Court for the Northern District of California under Judge Richard Seeborg, in April 2016, by federal judges which involves melanoma (skin cancer) cases.

By August 2017, more than 500 lawsuits were pending in the MDL.

Evidences:

  • Indication of usage in Medical Records
  • Indication of Usage in Pharmacy Records
  • Duration of Usage
  • Complications and their treatment after intake

Medical Record Review and claim validation of Viagra case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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