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.”
More than $1.3 inmedia_ countDr Berkeley Phillips is a medical director [email protected].
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DrMedicareHealthylife.com.au Rating(5)/DrMedicareHealthylife.com.TheNew York Timesreported today that a company is ordering a three-year supply of generic Viagra to patients that has been on the market for years, after a study found that a drug that's often used to treat impotence may have a much higher chance of being approved by regulators in the future.
The FDA has announced that the drug, which can be prescribed in pill form or as a spray-on form, has been found to be "dangerous" for patients, a spokesperson said.
Viagra, originally developed as a treatment for erectile dysfunction, has become an industry staple since its launch in 1998, and its sales have skyrocketed from more than $100 million in the US in 2011 to $1.4 billion in 2012. It's one of the most counterfeited drugs in history.
Viagra is still considered by regulators to be a serious drug in the treatment of erectile dysfunction, and its price has fallen significantly in recent years due to generic competition. The FDA has issued strict warnings to consumers about the safety of generic competitors, warning patients and doctors about the drug's side effects.
"Sildenafil, the active ingredient in Viagra, can interact with nitrates found in some prescription drugs, such as nitroglycerin, and can lead to dangerously low blood pressure and even death," the agency stated in a statement released Friday.
The FDA noted that a study that analyzed the safety of sildenafil in more than 80,000 patients showed that sildenafil was more likely to cause a heart attack in the men over the age of 80 who took the drug.
In June 2011, the FDA issued a warning to patients, the agency stated, that sildenafil was not associated with an increased risk of death in people with heart disease, a finding that is "not consistent with reports of increased incidence of death in the general population," the FDA said.
In the same year, the FDA also issued a warning to consumers, the agency stated, that a patient who took sildenafil had a decreased chance of developing a heart attack, and that it was not a cause for concern.
"While sildenafil may be a safe and effective treatment for erectile dysfunction, there are certain serious health risks associated with this drug, including dangerously low blood pressure and serious cardiac events," the agency stated.
The FDA also stated, "Patients should not take sildenafil if they have a known hypersensitivity to sildenafil or to any of its ingredients."
The company has filed a with the FDA to address the safety issues.
In a statement, Lilly, the US pharmaceutical giant, said that the company had conducted a safety study with more than 40,000 patients to determine whether Viagra, a prescription drug used to treat erectile dysfunction, caused a greater risk of a heart attack and a stroke than a placebo.
"As the FDA has previously stated, Viagra should not be taken by patients who have a known allergy to sildenafil or to any of its ingredients," the statement said.
As of May, the company had no plans to discontinue the sale of Viagra, but has stated that it was confident that the product will continue to be sold.
In January 2011, the FDA announced that it had received reports that a new drug developed by a company that also makes Viagra might cause an increased risk of heart attack, stroke, and heart failure.
The FDA said that "sildenafil is not expected to cause these serious side effects, however, as the risks of these side effects have not been reported in clinical trials or have been extensively studied in humans," the FDA said.
In February 2011, the FDA issued a warning letter to the makers of the Viagra product because of the increased likelihood of causing serious heart and blood vessel problems, the agency noted.
In February 2011, the FDA issued a warning letter to the makers of the Sildenafil spray-on-the-go, but it has not been linked to serious heart or blood vessel problems.
In November 2011, the FDA issued a warning letter to the makers of Viagra and advised that "the potential benefits of sildenafil outweigh any potential risks associated with this drug, including the risk of a heart attack and stroke.
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