Since the U.S. Food and Drug Administration (FDA) approved the use of the little blue pill – better known by its brand name, Viagra – in the 1960s, the drug has been advertised and marketed as a panacea for erectile dysfunction. While some people have reportedly been able to benefit from the treatment, others have complained about severe adverse effects. Now, as the FDA considers whether or not to approve a new study comparing the safety and efficacy of different dosages of Viagra, a class action lawsuit has been filed on behalf of those who have allegedly been harmed by the drug.
What Is Viagra?
Viagra is a medication approved by the FDA in the 1960s for the treatment of erectile dysfunction. The drug is a serotonin-norepinephrine reuptake inhibitor (SNRI), which indicates that it inhibits the reabsorption of both serotonin and norepinephrine, substances that are important for maintaining healthy mental and physical states. The FDA approval label for the drug indicates that it can be used along with a nitroglycerin spray – a drug designed to relieve chest pain caused by angina pectoris – for the treatment of erectile dysfunction. It is also useful in the treatment of depression and pre-menstrual syndrome (PMS).
Viagra’s Adverse Effects
Despite the drug’s initial success, Viagra has been dogged by complaints about adverse effects. One of the most common reported side effects is headache. According to the manufacturer, as many as 2 out of 3 people taking the drug experience headaches, which typically last for a few hours or less. Other side effects include photophobia, dizziness, flushing, and nausea. In rare cases, people taking Viagra have reported experiencing syncope (fainting), chest pain, and vision problems. In most cases, the side effects from the medication resolve once the individual stops taking the drug. However, in some instances, the side effects are so severe that they are life-threatening. As a result, the drug is reported to be associated with about 1 in 100 hospital admissions. Although the actual rates of adverse effects are unknown, it is likely that many people are not even aware that they exist because many side effects are experienced on a subconscious level and may therefore go unnoticed.
Is It Worth It?
Because of the risks that come with taking Viagra, many people are wondering if it is actually worth it. After all, if the side effects are so severe, why take the risk? While it is generally not advisable to question the value of medication without first consulting your physician, in some cases, the benefits of a medication may outweigh the risks. When this occurs, it is usually because the benefits of the medication are more significant than the risks. Another factor that determines the ‘worth’ of medication is the quality of the medication. When a medication is prescribed by a physician, it is usually because the physician believes that it is the safest and most effective treatment option available. As a result, when you choose to forgo the medication, you are essentially saying that you don’t trust the physician’s opinion or you think that there are safer and more effective medication options available. In these cases, it is usually not a wise decision to forgo the medication because too many people have experienced positive effects from it. In almost all cases, once you start taking the medication, you cannot stop because it will cause you to go into sudden and dangerous cardiac arrhythmia. As a result, the risk of heart attack or stroke is very high. In some cases, this risk is greater than the risk of becoming ill from the disease that the medication is designed to treat. In light of this, it is usually best to maintain treatment with the medication even though the risks may be higher than you are comfortable with.
New Study on Comparative Safety and Efficacy of Different Dosages
In light of the risks associated with taking Viagra, a new study conducted by the FDA was commissioned to “determine whether there are differences in the incidence, type, or severity of adverse drug reactions associated with different doses of Viagra.” In order to do this, the agency performed a pharmacovigilance analysis of all reports of adverse effects associated with different dosages of the medication from January 1, 2004, to December 31, 2016. The results of the study were recently published in the American Journal of Medicine and are summarized as follows:
- The incidence of serious adverse effects (defined as those that were life-threatening or required hospitalization) was 3.2% with low doses of Viagra (less than or equal to 100 mg), 2.5% with mid-range doses (101-250 mg), and 4.9% with high doses (greater than or equal to 250 mg).
- The difference in serious adverse effect rates between the low- and high-dose groups was not statistically significant.
- The rates of adverse effects were similar across dosage groups, with the exception of dizziness, which was more common with low doses than with higher doses of the medication.
- People who experienced adverse effects were more likely to discontinue use of the medication than those who did not. In particular, people who took either low or mid-range doses of the drug were twice as likely to discontinue treatment as those who took high doses.
While the study did not directly compare the efficacy of different dosages of Viagra, its findings do provide some insight regarding the varying levels of effectiveness of the drug. First off, it is clear that adverse effects are dose-dependent, as more people in the higher-dose group experienced adverse effects compared to those in the lower-dose group. As a result, the study does not provide much encouragement that people should continue taking higher doses of the drug even though these may be more effective. In fact, according to the study, taking a higher dose may be more likely to cause severe adverse effects than to provide any therapeutic benefit.
What Does This Mean for You?
If you’re concerned about the risks associated with taking Viagra, it might be a good idea to talk to your physician about alternatives. In some cases, a different treatment may be prescribed or suggested. If this is the case, you may be asked to try a different medication or a combination of medications. Alternatively, the risks and benefits of the medication may be reviewed and it may be decided that continuing treatment is not worth it in light of what you are already experiencing or the risks that you are willing to take. In these situations, it is usually best to stop taking the medication and try something else instead.
In general, the decision to take or reject a medication is a personal one and should not be made without medical advice. However, in some cases, the risks associated with a medication may outweigh the benefits and in these situations, it may not be a good idea to skip out on the medication. This will always depend on your personal situation and what other treatment options are available. In almost all cases, it is advised against taking a medication without discussing the risks and benefits with your physician first. Even then, it is usually not a wise decision to forgo a medication without first trying other treatment options.