A man in Los Angeles is suing an Internet service that lets him order prescription drugs without a prescription. When it comes to the drug he’s purchasing, the website has a few names on it.
The Food and Drug Administration has rejected several attempts to get Pfizer to change the labeling on the website to match its current label. A few days after the FDA approved Viagra, the website was shut down, and other sites continued to be unavailable, including the website for Viagra.
In response, the company sent a letter to the FDA seeking permission to remove the Viagra website from its website. The FDA refused. The company says it has no knowledge of any changes to the drug’s labeling.
The FDA also issued a warning letter to the site, saying the site’s content could contain harmful or dangerous information. The letter also says the site is operating illegally.
The FDA said it found no cases of counterfeit or ineffective drug products, and no cases of illegal online sale of prescription drugs.
“Consumers should be alert and instructed to ensure their online health care information is accurate and up-to-date,” the FDA said in a statement. “Any information on the internet that may be harmful or misleading should be thoroughly investigated and FDA issued enforcement actions can take.”
Originally Published: November 21, 2015 at 11:12 AM EST
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The U. S. Food and Drug Administration is warning consumers to avoid using a drug called sildenafil citrate, a Viagra that the company sells under the brand name Revatio, because the use of sildenafil can increase the risk of heart attack and stroke. The agency said that its warnings about the drug’s side effects were based on safety information and did not take into account how other ED drugs, like Cialis and Levitra, may interact with sildenafil.
The FDA issued a warning to the manufacturer on Thursday, calling the drug unsafe and adding that it does not meet current safety standards for any other drug.
“This is not a warning that the FDA is putting out to physicians and patients,” said FDA Commissioner Scott Gottlieb. “The only way to know that a drug, like Viagra, is safe is if it’s not approved by the FDA.”
In addition to the FDA warning, a spokeswoman for Pfizer said the company did not make the drug available to consumers until it received its approval for sale in the U. from the Food and Drug Administration in 1998.
Viagra is sold under the brand name Revatio because it is effective and well-tolerated.
The FDA’s warning comes two days before the second clinical trial to test the drug’s efficacy as well as safety in men with erectile dysfunction. The drug’s active ingredient, sildenafil citrate, is called vardenafil hydrochloride. The FDA added that the drug’s side effects, including impotence and vision loss, are rare, and that they are less common than those seen with other drugs that contain sildenafil.
The company said that its warning did not apply to patients taking nitrates for chest pain, according to its website. “We are aware of reports of patients experiencing heart attack, stroke, or heart failure related to the use of sildenafil, but we are not advising patients to use this drug, or any other nitrate drug, in order to reduce the likelihood of these effects,” said FDA officials.
The agency said it is reviewing safety information and other information submitted by manufacturers, and that it is working with regulators to update the labeling for sildenafil, and to provide more information about its safety and efficacy, and to address any concerns related to the drug’s use.
“Our warning is a good warning because it tells patients to avoid sildenafil and to seek medical advice if they experience any adverse reactions,” Gottlieb said.
Credit...: AlamyPhotograph: Alamy/ShutterstockThe FDA also said that it is reviewing the safety information and other information submitted by manufacturers.
The drug’s label includes warnings about heart risks, such as low blood pressure, sudden vision loss and low blood pressure in some patients.
“It’s important for patients to exercise caution and only use sildenafil in cases where there is a serious risk of heart attack or stroke and in the absence of such a serious risk,” said the agency’s statement.
A spokesperson for Pfizer said the company does not make any statement regarding the safety of the drug. But a spokesman for the company declined to discuss its decision to stop marketing the drug.
Originally Published: May 26, 2015 at 12:00 AM EDT
Image: Getty ImagesA man was arrested Thursday after allegedly having erectile dysfunction medication marketed by Revatio for sale without a prescription.
According to the FDA, the drug contains the active ingredient sildenafil citrate, which is used to treat erectile dysfunction.
The FDA said that the drug’s label has no warnings related to the drug’s effects on heart and blood pressure or that it does not meet current safety standards for any other drug. The drug has been prescribed to men who suffer from heart failure or who are at risk of having a heart attack or stroke.
The agency said it has received reports of heart attack, stroke, or heart failure, as well as some cases of chest pain, weakness and dizziness.
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