How A Little Blue Pill Changed The World

Viagra Makes History

Viagra is one of the most widely-known prescription drug names on the U.S. market. Often dubbed "the little blue pill", Viagra (sildenafil) was the first phosphodiesterase 5 (PDE5) inhibitor approved to treat erectile dysfunction (ED). ED is a common sexual problem for men and its frequency increases with age.

It is estimated roughly 30 million men in the U.S. and over 100 million men worldwide suffer from ED. A large U.S. survey determined about 50 percent of men 40 to 70 years of age experience some degree of ED.

The Unexpected Discovery of Viagra

The discovery that sildenafil could lead to an erection was an unplanned event. The sildenafil compound was originally developed by Pfizer for the treatment of hypertension (high blood pressure) and angina pectoris (chest pain due to heart disease). During the heart clinical trials, researchers discovered that the drug was more effective at inducing erections than treating angina. Pfizer realized ED was an unmet medical need and a major opportunity for financial gain.

In 1998, the FDA approved Viagra, the first oral treatment for erectile dysfunction, under a priority review.

Quick Success: The FDA-Approval of Viagra

At the time of its approval, Viagra had the fastest initial sales growth following its launch of any prescription product, reaching 2008 sales of close to $2 billion. Pfizer promoted Viagra and ED awareness via direct-to-consumer (DTC) advertising, which prompted men to seek medical advice and a prescription from their doctors.

For many men, the stigma and embarrassment of talking to their doctor about ED has declined since the introduction of Viagra and other PDE5 inhibitors.

The Impact of Erectile Dysfunction (ED)

ED, or the inability to achieve and maintain an erect penis for sexual function, can lead to performance anxiety, a negative impact on self-esteem and personal relationships, and even clinical depression.

In a survey published in BMJ, 62 percent of men reported a decline in self esteem, 29 percent reported a negative effect on a relationship, and 21 percent reported that their relationship had ceased due to ED. For many men, the inability to perform adequately during sex directly affects their feelings of masculinity.

What Causes ED?

Age alone is not a risk factor for ED, but underlying health issues such as diabetes, high blood pressure, obesity, high cholesterol, chronic alcohol or drug abuse, certain medications, and injuries can lead to impotence. Any condition that may restrict blood flow to veins over time, like smoking, can lead to ED.

Medical conditions like Parkinson's disease or Peyronie's disease (scar tissue build-up in the penis) may cause ED. Mental health issues can take their toll, too--depression or stress can result in loss of libido. Erection failures may occur repeatedly in men who experience performance anxiety due to ED.

Which Medications Cause ED?

Many medications have impotence or sexual dysfunction listed as a side effect. A medication review should be performed by a health care provider to determine if any prescription drug treatment may be contributing to symptoms. Medications such as antidepressants, blood pressure drugs, certain antihistamines, antipsychotics, drugs used for benign prostatic hypertrophy (BPH), and anti-HIV drugs may lead to ED.

If you regularly experience sexual function or ED problems, contact your doctor for evaluation and treatment.

Just the Basic Facts: How Viagra Works

Viagra works in response to sexual stimulation to increase the blood flow to the penis leading to an erection. Viagra does not result in an erection without sexual stimulation. When a man is aroused, muscles in the penis relax to allow this greater blood flow. Viagra helps to elevate the levels of a substance that causes the tissues to relax.

Viagra and other PDE5 inhibitors treat ED, but do not directly increase a man's sexual desire. However, knowing that one can perform better in bed may indirectly boost libido.

What's the Safest Way to Take Viagra?

Viagra (sildenafil) is taken by mouth usually as a 25 or 50 milligram (mg) tablet one hour before sexual activity. However, Viagra may be taken within a range of one-half hour to four hours before sex. The dose may be adjusted based on doctor recommendations, but it should not exceed 100 mg per dose or be taken more than once per day. Have your pharmacist check for drug interactions, too.

A physician will prescribe your specific dose. Men who use nitrates should never use Viagra or other PDE5 inhibitors (Cialis, Levitra, or Staxyn) due to severe, possibly fatal hypotension (low blood pressure).

Does Viagra Have Side Effects?

In general, the most common side effects with PDE5 inhibitors are mild and short-lived. Headache, flushing, heartburn, vision problems, nausea, and dizziness may occur. Report a sudden hearing or vision loss to your healthcare provider immediately. An erection lasting more then 4 hours (priapism) is a rare event, but if it occurs get emergency treatment.

Be sure to review Viagra drug interactions and precautions with your healthcare provider prior to use. Your dose of Viagra may need to be adjusted based on other drugs you may be taking.

Other Options for Erectile Dysfunction

The simplicity of taking an oral tablet for ED has revolutionized ED treatment. However, PDE5 inhibitors may not work in about 30 percent of men. It is important for men to know that there are other options are available for ED. Penile self-injection (Caverject), transurethral suppositories (MUSE), vacuum-assisted erection devices, and surgical penile prostheses are solutions that were used prior to Viagra, and are still available today.

These options may be useful for some; however, for many men they can be complicated, painful, and more expensive. Be sure to talk to your doctor.

Can Viagra Treat "Low T"?

Media advertising has dramatically increased the awareness of "Low-T" or low blood testosterone. Typically, a man's testosterone level is considered low if it's below 300 nanograms/deciliter. Men with low blood testosterone levels may show a lower sex drive, erectile dysfunction, brittle bones (osteoporosis), low muscle mass and higher fat accumulation.

Testosterone therapy, whether it be by injection, gel, skin patch or lozenge is the usual treatment to raise testosterone levels. However, at least one study has shown that sildenafil (Viagra) treatment can be useful for treatment of ED in men with "Low-T".

Viagra: Medical Necessity or Lifestyle Enhancer?

Some insurance companies will not pay for Viagra, citing the fine line between lifestyle enhancement and medical necessity. According to Pfizer, roughly 35 percent of insurance plans will not pay for Viagra or require a higher copay from the patient. This may be one reason why consumers turn to Internet purchase.

According to Pfizer, to help combat the counterfeit market, they now offer online Viagra prescription orders and home delivery through CVS Pharmacy. However, be sure to talk to your local pharmacist about Viagra safety and drug interactions if you have questions.

Counterfeit Viagra: A Dangerous Practice

Viagra has become the victim of Internet fraud due to its rapid success and famous name. According to Pfizer, 80 percent of the top 22 Internet sites that came up in search results for the phrase "buy Viagra" were selling counterfeit pills.

Products sold as "natural" or "herbal" Viagra claim to enhance performance; however, these illegal products have not undergone FDA review or approval. Fraudulent Viagra products contain unknown chemical ingredients that may pose a serious health risk.

Will Viagra Be Approved For Women?

More than 50 million women experience some type of sexual dysfunction. Studies looking at Viagra in women have theorized that sildenafil could increase genital blood flow and boost arousal. However, most studies have found a limited beneficial effect of Viagra for women. Lack of sex drive in a woman is a complicated process, often magnified by stress, hormonal changes, or lack of intimacy. Currently, there are no FDA-approved medications for treating low female sex drive. Osphena (ospemifene) has been approved for the treatment of vaginal dryness and dyspareunia (painful intercourse) in menopause that can interfere with intercourse.

Is There A Generic Viagra?

The manufacturer of Viagra, Pfizer Pharmaceuticals, has a patent on Viagra until 2020. Teva Pharmaceuticals, a generics manufacturer, gained tentative FDA approval for sildenafil, the generic version of Viagra, but in 2010 Pfizer sued Teva for patent infringement and won. A generic PDE5 inhibitor may not be available for sale until 2017 or 2018 when Levitra or Cialis are projected to lose patent.

Online advertisers offering "generic" Viagra are not selling an FDA-approved version of generic Viagra. In fact, online "generic Viagra" may be a counterfeit drug so consumers should beware of online purchases.

Finished: How A Little Blue Pill Changed The World

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Sources

  1. Urology Care Foundation. ED. Non-surgical management. Accessed online May 28, 2013 at http://www.urologyhealth.org/urology/index.cfm?article=60
  2. J. Tomlinson, Wright D. Impact of erectile dysfunction and its subsequent treatment with sildenafil: qualitative study. BMJ. 2004;328:1037. Accessed 5/25/2013.
  3. Keith A. The Economics of Viagra. Health Affairs 200;19:147-57. Accessed 5/25/2013. doi: 10.1377/hlthaff.19.2.147
  4. CNN Money. Isidore C. Pfizer to start selling Viagra online. Accessed online May 30, 2013. http://money.cnn.com/2013/05/06/news/companies/pfizer-viagra-online/index.html
  5. Up To Date. Patient Information. Sexual Problems in men. (Beyond the Basics). Accessed 5/31/2013 at http://www.uptodate.com/contents/sexual-problems-in-men-beyond-the-basics?source=related_link
  6. Pfizer Pharmaceuticals. Viagra. Accessed online May 31, 2013. http://www.viagra.com/viagra-prescription.aspx
  7. Mayo Clinic. Sexual Health. Accessed online May 28, 2013 at http://www.mayoclinic.com/health/viagra-for-women/AN01987
  8. Berman J, Berman L, Toler S, et al. Safety and efficacy of sildenafil citrate for the treatment of female sexual arousal disorder. The Journal of Urology. 2003;170:2333-38. http://www.ncbi.nlm.nih.gov/pubmed/14634409
  9. Spitzer M, Basaria S, Travison TG, et al. Effect of testosterone replacement on response to sildenafil citrate in men with erectile dysfunction: a parallel, randomized trial. Ann Intern Med 2012;157:681-91. Accessed June 6, 2013 online at http://www.ncbi.nlm.nih.gov/pubmed/23165659
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