By: Sarah Anderson
WASHINGTON (CBS News) — The Food and Drug Administration (FDA) approved a herbal supplement for treating erectile dysfunction in men with high blood pressure (ED).
The supplement, which is called “Eldestine,” is an herb known to treat erectile dysfunction in men with high blood pressure.
Eldestine is found in the blood vessel walls of the penis, which are called the corpus cavernosum, and is a key factor in erectile dysfunction.
The supplement, which is sold under the brand name of Viagra, is designed to boost blood flow to the penis to help men with high blood pressure.
“Eldestine is a natural product, but it can have adverse effects on the body,” said Dr. Michael K. Greenblatt, director of the FDA’s Center for Drug Evaluation and Research.
“The FDA has a duty to determine the safety and efficacy of any supplement,” he said.
The FDA also evaluated whether supplements containing natural, high-sodium foods such as spinach, beetroot, or guarana could help with ED. Greenblatt said that a supplement containing the herb, which can be found in most herbal teas, may help to improve blood flow to the penis.
Eldestine has been available for use in men since the early 1960s. It is sold under various brand names including Viagra, Sildenafil, and Revatio.
Greenblatt said that the FDA’s review of supplements that contain the herb has been negative. He said that more than a dozen supplements have been rejected by the agency.
The supplement is marketed as a treatment for hypertension, a condition in which blood pressure levels are raised too high, causing blood pressure to stay high and causing symptoms to improve.
Dr. Greenblatt, a professor of medical and biological sciences at UCLA who is treating the condition, said the FDA does not approve the use of herbal supplements in the treatment of ED.
“The FDA is aware of the potential side effects of this supplement, but it would be difficult to know what the benefits are,” he said. “The FDA is also aware of the risk for certain medications, and its approval may mean that these medications could interact with other medications.”
The FDA’s review of supplements to treat ED has been negative. Greenblatt said that the supplement’s safety and efficacy have not been confirmed by the FDA.
In a statement, FDA said that it has not received approval for the supplement, as well as the product’s label, to treat ED. Greenblatt said that the agency has given the supplement a “black-box” warning.
“The supplement does not appear to be safe or effective in the treatment of ED,” he said.
The supplement’s label also states that it is “not indicated for use in women.” The supplement also does not say how it might interact with other medications or supplements.
Greenblatt said the supplement is “very important” for the FDA to make sure that it is safe, safe, effective, and not overuse, as well as for the public. “We don’t want to overuse these products,” he said.
According to a statement, the supplement should not be used for any reason other than the FDA has approved it.
The supplement’s label states that it is not indicated for use in women. Greenblatt said the FDA has not received approval from the agency for the supplement.
Greenblatt said that the supplement’s label is clear and includes no mention of the herb.
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