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    Sildenafil black box warning


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    In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because the U. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text. The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued. For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people were given the drug. Later research indicated that after receiving an FDA advisory, there was a decrease in rosiglitazone use, due to a combined effect of media exposure, advisory, and scientific publications, whereas pioglitazone (with a similar advisory but less media exposure) did not similarly decrease in use. 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.

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