A drug company is warning patients not to take Viagra, the little blue pill that treats erectile dysfunction, because it causes a potentially deadly side effect.
The Food and Drug Administration said it’s concerned about the side effects of the drug, which treats erectile dysfunction in men, and about the potential for dangerous drug interactions.
A spokesman for Pfizer, which manufactures Viagra, declined to provide more details about the safety issues, but said it has taken Viagra’s risks seriously. The company has not given up hope that it will reduce the risk of Viagra’s side effects.
The drug maker, Pfizer Inc., has been forced to revise the label to include information about Viagra’s effects on men’s sexual function and erectile dysfunction.
The FDA’s latest warning, in its most recent warning about the drug, said the drug can cause dangerous side effects in men who use nitroglycerin or other nitrates, such as isosorbide dinitrate, a drug used to treat angina and other heart problems.
But the agency also said that Viagra’s side effects are very rare in men who take it.
The agency added that it had not given any warning about the risk of serious side effects of Viagra.
The drugmaker said it is making the drug available to patients only as a generic product.
The FDA has also issued a “black box warning” warning about the drug’s side effects in a recent warning about sexual dysfunction and an article in the Wall Street Journal that said “a significant number of men have reported experiencing erectile dysfunction while taking the medication.”
“Viagra has been on the market for years and is well known for its ability to treat erectile dysfunction,” said Dr. Steven Nissen, the FDA’s deputy director for cardiovascular and cardiovascular disease. “Viagra has been on the market for years and is well known for its ability to treat erectile dysfunction.”
An FDA spokeswoman did not immediately respond to a request for comment.
Viagra, sold by Pfizer as the little blue pill, is the brand-name drug that Pfizer is making available to patients who have been diagnosed with erectile dysfunction. Viagra comes as a generic version to a brand-name version.
Originally Published: December 16, 2013 at 3:00 AM EST
Viagra, the little blue pill that treats erectile dysfunction, is the brand-name drug that Pfizer is making available to patients who have been diagnosed with erectile dysfunction. (AP) -- Pfizer and its sister company, Bayer AG, said Wednesday that they have received a letter from the FDA seeking information about the side effects of the drug.Viagra has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.
Common side effects reported from Viagra use include:
More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Viagra. Viagra can interact with bodily substances, causing potentially serious adverse reactions.
Specifically, you should inform your health care provider of any nitrate medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.
In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.
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The most common side effects of this medication are:
As with all prescription medications, inform your doctor if you:
This may not come as a complete side effect, but if you experience any changes in your vision, ringing in the ears, pain in the muscles, blurred vision, sensitivity to light, difficulty urinating, or any other side effects, contact your doctor immediately. You will be reviewed for prescription conditions if you wish to continue taking this medication.
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MANUFACTURER: A team of scientists at the Centre for Rare Disease (CRD) of the University of Southampton in Southampton, UK, has found the highest doses of the drug Viagra of the active substance were found in a sample of men in the western world.
The team reported in the journal PLOS ONE reported results from an independent trial which used the drug to treat erectile dysfunction in men over the age of 18.
Viagra, the active substance in the drug, is a phosphodiesterase-5 inhibitor. It was originally developed as a treatment for hypertension and high blood pressure. It has been used for a number of conditions and is thought to work in the penis.
But in 2013, researchers from the CRD announced the results of the ongoing trial in a single, low-dose study.
The study, known as the ‘Clinical Pharmacology for ED Trial’, examined whether a single dose of sildenafil citrate improved erections in men with erectile dysfunction.
Sildenafil was administered to eight men with erectile dysfunction, aged 18 to 41. The men had a mean age of 62 years, a mean blood pressure of 90/25 mmHg and a mean left ventricular mass index (LVMI) of 0.8. They were given a single 50mg dose of the drug for four weeks.
Sildenafil was statistically effective in the group with a mean duration of action of -11.1 minutes and average dose, which was higher than the dose used in previous trials, was -5.1mg.
However, the study found that sildenafil was not effective in men with a history of sexual activity and, as such, was not associated with an increased risk of cardiovascular events.
Researchers also found that the drug did not affect other aspects of erectile function.
In addition, the study showed that there was no difference in blood pressure between the two treatment groups and, although sildenafil had a better effect on erections, it was less effective on sexual activity.
The results are part of the large trial of sildenafil that has been conducted at the Centre for Rare Disease since the drug was first licensed for use in the UK in February 2013.
The researchers said: “Sildenafil was shown to be an effective treatment for erectile dysfunction in men who had not been treated previously.
"Because of the small number of men who were treated, this is a potentially serious side effect and could increase the risk of serious health problems.”
The trial was stopped early because of the following problems:
The men in the trial had a history of high blood pressure, heart problems and diabetes. Sildenafil had a very low incidence of this side effect.
A separate small, double-blind, placebo-controlled trial was also conducted in the UK to see if a single dose of sildenafil improved the symptoms of erectile dysfunction in men with diabetes.
The men had a history of high blood pressure and hypertension. It is unlikely that sildenafil would be an effective treatment for these conditions and their side effects are thought to be very low.
A separate double-blind, placebo-controlled trial was also conducted in the UK to see if a single dose of sildenafil improved the symptoms of erectile dysfunction in men with diabetes.
The study was stopped early because of the following problems:
The treatment was stopped early because of the following problems:
A British pharmaceutical firm is developing an innovative drug for the treatment of erectile dysfunction.
Dr. Marc E. Chiesa, a Pfizer-headquartered biopharmaceutical company based in Montreal, Canada, is launching a clinical trial to evaluate its Viagra (sildenafil) pill.
The company is set to start the clinical trial in early spring.
In a Phase III study involving nearly 2,000 men, Chiesa is able to successfully address the psychological and physiological barriers that contribute to the inability to get and keep an erection.
This will be the first of two clinical trials for Viagra to be launched in the UK and in the US.
The first clinical trial to be completed in the US is expected to begin in early spring.
It will examine how Viagra works to enhance erection, the psychological effects of erectile dysfunction, and the effectiveness of the medication.
The trial, which will be conducted by a team of clinical scientists from Pfizer and Dr. Chiesa, will assess the effects of Viagra on men who have erectile dysfunction and the psychological and physical barriers that contribute to it.
The results will be published in the British Medical Journal in Spring 2014.
The research is being conducted by the University of Montreal researchersChiesa, who is based in Montreal, Canada, is the first pharmaceutical company to launch a trial for Viagra, with the drug now available in the U. K.
A Pfizer-headquartered biopharmaceutical company in Montreal, Canada, is a biotechnology company that has developed a drug for the treatment of erectile dysfunction. The drug is called Viagra. The drug, developed by Pfizer, is known as Sildenafil.
The company is working to develop an effective drug for erectile dysfunction and other sexual disorders, such as low libido and impotence.
Viagra is the first oral medication approved for the treatment of erectile dysfunction. The drug will be sold by Pfizer and Dr. Chiesa, who also is based in Montreal, Canada.
A clinical trial, which will be conducted by the company, is expected to begin in early spring.
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