The Food and Drug Administration approved sildenafil (Viagra) for the treatment of erectile dysfunction in men under 18 years old in 1998. (A study in 2015 found that over half of all men taking sildenafil had erectile dysfunction, a condition in which men cannot get or keep an erection firm enough for sexual activity.)
According to an article published on Monday in, a British medical journal, the drug works by relaxing the smooth muscle in the penis. This allows men to have more erections, which is why Viagra is also called the "little blue pill."
The FDA has not approved sildenafil for the treatment of erectile dysfunction, however, and it is not clear whether it is safe and effective for such use. It is not known if sildenafil is as effective as Viagra.
According to the, the FDA will review the data from the three separate studies and will decide whether the use of sildenafil for erectile dysfunction should be withdrawn from the market. That will include a comparison of Viagra, a popular medication used to treat erectile dysfunction. The FDA also will review studies that compared sildenafil with other similar drugs, such as, which are also used to treat erectile dysfunction.
Sildenafil has been available for some time now. But the FDA has stopped approving sildenafil for other uses.
The FDA issued a black-box warning last year about the risks of taking sildenafil and other drugs that contain nitrates (such as nitroglycerin) or nitrite (such as isosorbide dinitrate) because of the risk of a dangerous drop in blood pressure. The FDA said that it was aware of the side effects and that sildenafil was not associated with a cardiovascular event.
This week, the FDA updated its warning about the risk of side effects and is issuing a letter to consumers advising them to stop taking sildenafil, saying that it is not safe for use in children, and that there is not enough data to recommend it for use in adults.
A note in theJournal of the American Medical Associationon Monday reads: "The FDA has not approved sildenafil for use in children, but the drug was approved for use in adults as of December 1, 1998."According to the, there is no evidence that sildenafil has an increased risk of serious cardiovascular events. Viagra has been linked to a very serious heart attack in some people.
The FDA issued a warning about the risk of serious side effects from taking sildenafil, but not for the other drugs containing nitrates. It noted that there is no evidence that sildenafil has a higher risk of causing a heart attack or another type of cardiovascular event than is found with isosorbide dinitrate.
A spokesman for Pfizer, the maker of Viagra, said in a statement the company is reviewing the data from the three studies.
A spokesman for the FDA said, "The FDA is aware of the safety and efficacy of sildenafil. There is insufficient evidence that sildenafil is safe and effective for this use. Patients taking sildenafil may be at a greater risk for developing certain adverse events, such as a serious heart attack, and those taking sildenafil may be at a greater risk for a serious event."
The drug was not approved for use in children.
on Tuesday stated: "The safety and efficacy of sildenafil have not been studied in children. However, sildenafil is not approved for use in children in the United States."The FDA issued a warning about the risks of taking sildenafil and other drugs that contain nitrates (such as nitroglycerin) because of the risk of a dangerous drop in blood pressure.
on Tuesday stated: "The safety and efficacy of sildenafil has not been studied in children. However, sildenafil is not approved for use in children in the United States.Sildenafil citrate, commonly known by the brand name, is a prescription-only medicine used to treat erectile dysfunction (ED) in adult men. It works by improving blood flow to the penis, helping to achieve and maintain an erection during sexual activity.
Sildenafil is available in 25mg, 50mg, and 100mg strengths.
Sildenafil has been shown to be effective in up to 80% of men with ED, with effects typically noticeable within 30 to 60 minutes, and lasting for up to 4–5 hours.
Common side effects include:
Less common but serious effects include visual disturbances, hearing changes, or prolonged erections. Seek medical attention if severe or persistent side effects occur.
Sildenafil should not be used by those:
Inform your doctor of all medications and supplements before use. Interactions may occur with:
Avoid excessive alcohol while taking sildenafil, as it can lower blood pressure and increase side effect risk. Use with caution if you have any heart-related conditions.
Sildenafil is available by prescription only in the UK.
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2023-08-16
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PronunciationUSA alternativesBrand:Viagra
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