Is Viagra/Sildenafil Safe?

sildenafil-actavis-100mg-4-tablets_1“Is it safe?” the question asked by so many before taking a new medication.

Unfortunately, there is no straight yes or no answer to this sort of question. Whilst the manufacturing process of all drugs is tightly regulated and controlled in order to control risks, there is little that the industry can do to predict how each individual will respond to a medicine. For this reason, there is always some degree of risk when taking a medication and Viagra is no exception. Add to this improper use of the medication by a patient either intentionally or by mistake and the risk for detrimental side-effects from Viagra use rises yet further.

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Within manufacturing, quality control measures are in place to ensure that the drug is what it says it is, that the correct amount of drug is present in each individual capsule and that both the active pharmaceutical ingredient (drug) and the excipients (other compounds used in production of a tablet, other than the drug) have limited contamination with potentially harmful impurities or micro-organisms. All of these standards that must be met are set out in the British Pharmacopoeia and should be followed by law. All legitimate drug companies will produce medications to these standards in an attempt to reduce the risk of harm to the patients. In addition to this, the pharma companies are also required by law to produce an in-depth patient information leaflet to inform patients on how to use the medication, when to avoid taking the medication and usual and unusual side effects associated with the medication.

It is important to note that these standards are only enforced on legally operating pharmaceutical companies, this, therefore, means that safety of all medications, not just Viagra, depends on how the patient uses the medication including compliance with instructions for use, only taking the medicine when required and other medications that the patient is taking. Safety of medicines is also dependent on the genetic disposition of the patient which can affect things such as allergic responses and metabolism and excretion of drug substances.

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Genetic Disposition:

  1. Allergies:

Allergic reaction to viagraSome patients may possess a particular genetic makeup which causes them to be sensitive to Sildenafil which is the drug found in branded Viagra. This causes an allergic reaction caused by the immune system over-reacting to the presence of the Viagra.

Generally, in these people, Viagra is taken in and is detected in the body by an immune system antibody known as Immunoglobin E. This antibody acts on other immune system cells stimulating the release of inflammatory mediators. It is these mediators that bring about the classic symptoms of an allergic reaction. In some individuals, the resulting symptoms may be mild, and little more than uncomfortable for the patient, however in other cases the response can be extremely severe and even life-threatening. The inflammatory mediators released can act on tissues in the body causing them to swell in an attempt to contain the foreign particle, in this case, Viagra. This inflammation and swelling can lead to shortness of breath, difficulty breathing, changes in heart rate and many more effects. If severe enough this reaction may be fatal.

Whilst severe allergic reactions to this drug are rare, it is for obvious reasons that those individuals with a known sensitivity to Viagra or any of the other ingredients present in the medication should not be given it.

  1. Genes controlling metabolism and excretion of the drug:

GenesWithin the body, a group of enzymes known as Cytochrome P450 enzymes are responsible for the breakdown of most drugs that enter the body. Viagra is no exception to this. It is broken down by the enzyme CYP3A4. The proportion of this enzyme in an individual can also affect the safety of Viagra in the body. In the majority of the population, two copies of the gene responsible for the production of CY3A4 are present. This is the standard on which recommended doses of Viagra are based. However, in some members of the population, only one copy of this gene may be present. This means that the breakdown of the drug is much slower than in those with full CYP3A4 function. This can lead to the build-up of Viagra in the blood which may lead to an overdose. This can be unsafe for the patient as it can lead to irregular heartbeat, chest pains, painful prolonged erections etc. Immediate medical help should be sought if an overdose is suspected in order to reduce the risk of permanent effects. Due to the potentially serious results of an overdose, those who are slow to break down Viagra should be monitored carefully or prescribed an alternative. Again, in the majority of people this will not be an issue but due to the seriousness of the potential outcome, it should be noted.

Patient Compliance:

Viagra is a medication which is subject to some level of abuse. In recent years, it has been reported that more and more men not suffering from erectile dysfunction are using Viagra. This is due to the fact that the medication in healthy individuals can bring about a larger and more prolonged erection. This is not safe & can lead to the individual developing erectile dysfunction as a result. The safety of Viagra in healthy individuals is not known and therefore the use of the medicine when not necessary should be discouraged.

assured-pharmacy-logoFor those men who genuinely are suffering from erectile dysfunction and therefore do require the medication, there are a few things which you can avoid in order to make the use of the medicine as safe as possible. Firstly, it is important to ensure that you purchase Viagra from a reliable source ( such as Assured Pharmacy!) as this ensures that the products have been subjected to rigorous quality control procedures before reaching the market. Buying from a less reliable source may increase risk as these quality control measures will not have been in place and there is a possibility that it might not even be Viagra in the medicine you have purchased! In addition to this, men suffering from ED can reduce the risk of adverse effects from the medicine by ensuring that you take the medicine in accordance with the instructions provided by either a GP or pharmacist or if all else fails, on the patient information leaflet included in the box. This will ensure that you aren’t taking an underdose, in which case the drug may not do its job, or an overdose, whereby unpleasant and potentially dangerous side effects may present.

The final potential safety issue with Viagra that I will be looking at is the potential for it to interact with other drugs. Viagra has been shown to interact with some antibiotics such as Cimetidine and Erythromycin. This is because these drugs are broken down by the same device responsible for the breakdown of Viagra. The two drugs then effectively compete to be broken down. This results in less Viagra being broken down in a given time, which leads to its concentration rising and therefore the effects, both positive and negative, will increase in intensity and duration. Care should be taken when using Viagra and the above medications together and should any side effects present, the Viagra should be stopped immediately. In addition to this, because Viagra causes vasodilation of blood vessels and therefore decreases blood pressure, if this drug is administered alongside a blood pressure lowering medicine then there is the potential for the effects to be additive. This may mean that blood pressure falls too much and the patient becomes hypotensive – leading to dizziness, lightheadedness, fainting, nausea etc. As with any drug, there are many drug interactions possible, care should, therefore, be taken by the prescriber, and the patient in watching out for adverse effects.

In conclusion, as with all drugs there is the potential for safety issues with Viagra, however so long as you as the patient are compliant with the instructions provided, and that care is taken to monitor adverse effects etc, then the safety of Viagra is no less than any of the other hundreds of thousands of medicines on the UK market.

 

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References:

http://www.rxlist.com/viagra-drug/side-effects-interactions.htm

http://en.wikipedia.org/wiki/Allergy

Professor Tracy Robson, QUB, 2014 Lecture on Pharmacogenomic influences on drug metabolism

 

Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected].

2 thoughts on “Is Viagra/Sildenafil Safe?

  1. can I take Viagra with blood pressure reducing tablets

    1. It will be perfectly safe to take medication to treat erectile dysfunction (ED) if you are taking anti-hypertensives.

      In order to prescribe safely our doctor would need to have a complete record of your medication.

      Best Wishes

      Angela Lillie
      Pharmacist
      Assured Pharmacy
      01625 460 621
      http://www.assuredpharmacy.co.uk

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