A Pfizer-sponsored investigation into the effects of a new pill to erectile dysfunction drug Viagra has found that the Food and Drug Administration (FDA) is warning patients that the drug has been found to cause dangerously high blood pressure. The warning is based on an analysis of more than 5,000 clinical trials with the drug.
Pfizer's research found that taking Viagra increased the risk of heart attack, stroke and death in those men who took the drug.
The study was conducted by researchers at the University of California, San Francisco and Pfizer in California. The FDA had warned the company about the risk of heart attack and stroke. The study was published online in the July 15 issue of the journalPharmaceuticals and Drug Design.
"Our findings demonstrate that taking Viagra, in combination with other drugs, could cause potentially life-threatening blood vessel damage and death," said Robert J. Zahn, professor of medicine at the University of California San Francisco and a researcher with the FDA's Center for Drug Evaluation and Research.
The study was led by the University of California San Francisco School of Medicine. Zahn said that he is also a member of the advisory committee on Viagra. The agency said its warnings were based on the findings of more than 5,000 clinical trials. "It is important to note that while some people may be more susceptible to heart attack and stroke, it is not an inevitable outcome of taking Viagra," he added.
Pfizer said in a statement: "We understand the potential for heart attack and stroke, and are committed to working with regulators to provide appropriate and safe treatment options for patients with heart disease."
Zahn said he is not sure why the drug has been found to cause these events. He said that he and his team believe it is due to a change in blood flow to the penis during sexual stimulation.
He said the study was designed to determine whether Viagra had a similar effect on the heart or other cardiovascular problems, but that its results were limited to a small number of participants.
"There are some limitations to this study," he said. "It was a retrospective analysis of more than 5,000 clinical trials. This study cannot prove causality because of the small number of men who took it."
The study was conducted by researchers at the University of California San Francisco and Pfizer in California. Zahn said that he and his team were excited about the potential of Viagra to treat erectile dysfunction. "I really want to feel better before I go to bed," he said.
In an editorial, Dr. Janssen Kavoussi, M. D., chair of the Department of Endocrinology and Metabolism, said that while the use of Viagra can lead to serious side effects, the safety of Viagra has not been established.
"There is no evidence that Viagra is associated with a greater risk of cardiovascular events," she said.
Pfizer also said it is not certain whether Viagra caused more serious side effects than nitrates and may not be able to be used safely, or whether Viagra could cause more serious side effects.
Pfizer did not immediately respond to an email seeking comment on the study's contents. The FDA did not return an messages phone call for comment.
Pfizer spokesman David Korsman said that Viagra was a brand name for sildenafil. It is sold under the brand name Revatio.
Zahn said he was concerned about the increased risk of serious side effects with Viagra. "In clinical trials, the incidence of serious adverse events increased from 0.3% to 1.2%, with a greater occurrence of cardiovascular events and stroke."
The FDA did not provide specific information about Viagra or other drugs that may interact with Viagra. Zahn said he is not aware of any drug that may interact with Viagra or other drugs.
The company also noted that the study was sponsored by Pfizer, and was conducted by a group of pharmaceutical companies and not by the FDA.
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Keep medicine in original packagingProduct informationThis product is a Prescription Only Medicine (S4) and is sold by Healthylife Pharmacy. The S4 tablet is a prescription product, and the S4 should only be taken by those who have a history of severe or ongoing serum and breast cancers. It is not recommended for use in women. Please consult your doctor for personalized advice regarding your patients needs.
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Priceongevity>H2-blockersdisease conditionsMedications interacting with this product may interact with similar medications such as:
Nitrates may interact with alkyl nitrites (often prescribed for chest pain) such as glycerone, Nencers, or Nippostrathe. In addition to nitrates, alkyl nitrites can also increase the risk of developing a life-threatening condition called angina, which is characterized by chest pain, nausea, sweating, and irregular heartbeat. If you are taking these medications, it is strongly recommended that you consult your doctor before use.
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H2-blockers may decrease the effectiveness of oral contraceptives. If you are using these medications regularly, it is recommended that you consult your doctor before use.
Men in the UK will soon be able to buy Viagra over the counter for the first time after the erectile dysfunction drug was reclassified.
Those aged 18 and over will no longer need to see a GP for a prescription after the Medicines and Healthcare products Regulatory Agency (MHRA) announced that it is changing the status of Viagra Connect tablets so they can be sold in pharmacies following a conversation with a pharmacist.
US pharmaceutical company Pfizer said it is working on plans to launch the non-prescription version of the medicine in the UK in the spring of 2018. A four-pack of the sildenafil tablets will cost around £19.99 and an eight-pack £34.99. Men who buy it will be advised that they can take a 50 mg tablet an hour before having sex, but should not use more than one pill a day. Sildenafil is already available on NHS prescription free of charge.
The decision to reclassify the drug follows a public consultation, the MHRA said. Pharmacists will be able to determine whether treatment is appropriate for the patient and can give advice on erectile dysfunction, usage of the medicine, potential side effects and assess if further consultation with a general practitioner is required.
“The move to make Viagra Connect more widely accessible will encourage men to seek help within the healthcare system and increase awareness of erectile dysfunction.”
Mick Foy, Medicines and Healthcare products Regulatory Agency
But some men, including those with severe heart problems, those at high risk of heart problems, liver failure, kidney failure or those taking certain “interacting medicines”, will still need to be prescribed the drug under the supervision of a doctor.
It is hoped that making the drug more widely available will mean than men who may have not previously sought help will be more likely to do so. Health officials also hope the move will also help steer people away from buying drugs websites operating illegally.
The MHRA said that erectile dysfunction medicines are a “popular target” for criminals selling unlicensed and counterfeit medicines, over the past five years the Agency has seized more than £50m of unlicensed and counterfeit erectile dysfunction medicines.
“This decision is good news for men’s health,” said Mick Foy, MHRA’s group manager in vigilance and risk management of medicines. “The move to make Viagra Connect more widely accessible will encourage men to seek help within the healthcare system and increase awareness of erectile dysfunction.
“Erectile dysfunction can be a debilitating condition, so it’s important men feel they have fast access to quality and legitimate care, and do not feel they need to turn to counterfeit online supplies which could have potentially serious side effects.”
Dr Berkeley Phillips, UK medical director at Pfizer, said: “The availability of Viagra Connect in pharmacies from next year will offer men who are eligible for the product a new and convenient way to access sildenafil, a commonly prescribed treatment for erectile dysfunction.
“We understand some men may avoid seeking support and treatment for this condition, so we believe giving them the option to talk to a pharmacist and buy Viagra Connect could be a real step forward in encouraging more men into the healthcare system.
“As erectile dysfunction may be a sign of an underlying condition such as diabetes, high blood pressure, or heart disease, there could also be a wider benefit to public health in the long term. We hope that this forthcoming new opportunity to purchase a genuine treatment via pharmacy will also reduce the likelihood of men turning to potentially ineffective and dangerous counterfeits from illicit sources.”
About "popular target"Quinine, which is also in a re-classification, is a well-known prescription erectile dysfunction medication. But will it help high street pharmacies get ED? Dr Berkeley Phillips, Pfizer's UK medical director,ocrinology and sexual and renal medicine, and Dr Michael Curtissen, the UK anti-dyskinesal medical director at The North American Association of Anti-Dysphoric itch healing or urinary care specialist, say. “Viagra Connect is an effective option for those who are finding it difficult to swallow traditional herbal therapies,”‘s second treatment “is still a popular and popular target.” “A legitimate option could be to try pill identical pills with sildenafil and ultimately get the benefit ofBride.
This product is manufactured by:
Apotex
Apotex (manufactured by: Pfizer) and Sandoz (manufactured by: Sandoz) are manufacturing and producing this brand product.
The specific product is sold under the brand name VIAGRA Tablets, which is indicated for treating erectile dysfunction in adult males. The active ingredient is Sildenafil Citrate, which is the same in both tablets. The tablets contain the same active ingredients as the brand name Viagra Tablets.
The price for a pack of 6 tablets of VIAGRA Tablets is approximately €2,900. This product can be obtained from:
Apotex (manufactured by Pfizer) and Sandoz (manufactured by: Sandoz) are manufacturing and producing this product. The specific product is sold under the brand name VIAGRA Tablets.
The price for a pack of 4 tablets of VIAGRA Tablets is approximately €1,500.
The prices for a pack of 2 tablets of VIAGRA Tablets are approximately €1,000.
The FDA says,
This is not the first time the FDA has issued a warning about the use of Viagra.
In a recent issue of the Journal of Sexual Medicine, Dr. John Leucht of the University of Missouri, Kansas City, wrote
This is the first time the FDA has issued a warning about Viagra.
In fact, the FDA has issued a warning about the sexual dysfunction associated with the use of Viagra.
The drug has been known to cause sexual dysfunction.
It’s important to note that the FDA does not recommend Viagra for the treatment of erectile dysfunction.
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