Viagra lawsuitViagra

Viagra, the first medication produced to treat erectile dysfunction (ED) was approved in 1998. It quickly gained notoriety and is still the top selling prescription medication produced by the pharmaceutical giant Pfizer.  In Viagra’s peak sales year of 2012, revenue from Viagra has been reported at over $2 billion with about 8 million prescriptions written.  As many as 45 million men have used Viagra in its decade and a half lifespan.

Viagra is the brand name of the generic medication sildenafil.  It was first patented as a heart medication for angina but early clinical studies showed that it was not effective for that use.  The studies also showed that it had a side effect – increased numbers of erections in men.

Within the first weeks after approval, more than 40 thousand prescriptions had already been filled.  It was featured the same year in both Time and Newsweek magazines and discussed on Larry King Live.

Pfizer hired Bob Dole, former US Senator and Presidential nominee as a spokesperson and coined the term “ED” to address the reason for using the medication.  Viagra became so popular that it was featured in the hit television show “Sex and the City” .

In 2000, reports began to surface that hundreds of patients may have died while taking Viagra in the first year that it was on the market.  Despite cardiology concerns, the Food and Drug Administration (FDA) approved Levitra and Cialis for the same indication by 2003.

In 2005, a consumer advocacy group requested that the FDA require a black-box warning be added to Viagra and other impotence medications regarding an increase in incidenses of blindness after 48 patients had reported cases of non-arteritic ischemic optic neuropathy (NAION) between 1998 and 2004.  Less severe warnings had already been added but a black box was not added.

In October of 2007, Viagra labeling was modified to include warnings about sudden hearing loss after the FDA had received 29 reports regarding patients who had sudden hearing loss within a short period of time of taking the medication.  In 2008, Viagra and other ED medications had warnings regarding amnesia or temporary memory loss added to labeling.

In April of 2014, a study published in the Journal of the American Medical Association (JAMA) showed that data from over 25 thousand men taking Viagra indicated that men taking Viagra had an 84% increased risk of developing melanoma, one of the deadliest forms of cancer.  Men who had previously taken Viagra continued to be at risk even when the drug was discontinued.

Viagra was set to go off patent in 2009 but received a patent extension to prohibit generic medication from entering the market.  Pfizer is currently in litigation with generic manufacturers that are challenging the patent extension.

What is Viagra

Viagra (sildenafil citrate) is “the little blue” pill that is used as a treatment for erectile dysfunction.  Erectile dysfunction is a fairly common occurrence in aging men and may be related to prostate enlargement or falling testosterone levels.

Viagra is one member of a class of medications known as PDE5 inhibitors.  It and other members of the class work to help create erection in men by acting as a vasodilator to increase blood flow to the penis.  Blood engorgement of the penis is necessary for the development of an erection.

Viagra is taken on an “as needed” basis when the patient wants to have sexual activity.  It is available as a 25 mg, 50 mg and 100 mg tablet to be taken by mouth.

Drug Interactions and Side Effects of Viagra

Like most medications, Viagra may interact with certain medications.  Most of the drug interactions are not severe.  Viagra also has a number of side effects.  Many of the side effects of Viagra are mild, but some are more severe and can become life-threatening.

Viagra drug interactions may include:
  • Medications that are metabolized by the liver such as Tagamet, Erythromycin, HIV medications (increases Viagra concentrations)
  • Prostate medications such as Cardura or Flomax (decreased blood pressure)
  • Blood pressure medications such as Minipres, Vasoflex or Hytrin (decreased blood pressure)

Mild Viagra Side Effects

Viagra has a number of side effects which occur because of its vasodilation effects.  Common side effects may include:
  • Headache
  • Flushing
  • Indigestion
  • Nasal congestion
  • Urinary Tract Infection
  • Dizziness
  • Back Pain
  • Changes in heart rate and blood pressure
  • Priapism (extended erection which may cause permanent damage to penile tissue)

Some side effects of Viagra may be severe and in some cases are permanent or life-threatening.

Viagra and the Heart

Viagra has been suspected of causing heart complications in patients who have taken the medication, even if for a short period of time.  Viagra is a vasodilator and was initially investigated for the treatment of angina, a heart condition causing chest pain.

Side effects of Viagra that are related to the heart may include:
  • Angina
  • EKG changes
  • Rapid heart rate
  • Drop in blood pressure causing dizziness
  • Heart failure
  • Heart attack

It was reported as early as 2000 that Viagra may have contributed to the deaths of nearly 500 men in the first year that it was on the market.  These reports have not been linked directly to Viagra but any heart symptoms should be reported to a physician immediately.

Viagra and Hearing

Viagra has been known to cause a sudden loss of hearing, shortly after taking the medication or within a few days.  It may cause hearing loss due to its vasodilation effects.  It may also cause changes in blood supply in certain areas of the brain that may contribute to tinnitus, hearing loss and migraine headaches.  Most of these types of effects are temporary but should be reported to a medical professional.

Viagra and Vision

Viagra has been known to cause a number of side effects related to the eyes and vision.  Less severe side effects may include:

  • Irritation
  • Dilation of the pupils
  • Photophobia or light sensitivity
  • Dry eyes
  • Eye pain

More severe effects include multiple reports of non-arteritic ischemic optic neuropathy (NAION) which may cause blindness.  This is a permanent change to the optic nerve due to swelling of the tissue surrounding the eye.  The condition does not go away after discontinuing the medication in most cases.

Viagra and Cancer

A study published in the April 2014 edition of the Journal of the American Medical Association (JAMA) reported that data examined from nearly 26 thousand men showed that those who were taking Viagra and those who had previously taken the medication were nearly twice as likely to get the skin cancer, melanoma.

Melanoma is the deadliest form of skin cancer.  Each year, approximately 9,700 people in the US die from Melanoma.  According the American Cancer Society, about two-thirds of those are men.

Viagra may use the same genetic pathways that allow Melanoma to develop but it does not increase the risk of other, less harmful skin cancers such as basal cell or squamous cell carcinoma.  Melanoma has an overall 90% survival rate but the survival rate drops to about 16% if not caught in the early stages.

Viagra Lawsuits

A number of lawsuits have been filed against Pfizer, the manufacturer of Viagra due to the serious side effects of the medication.  Complaints about the medication have included:
  • Sudden loss of vision or significant visual impairment
  • Sudden loss of hearing or occurrence of tinnitus (ringing of the ears)
  • Heart complications that may cause fainting, heart attack or stroke
  • Skin cancer development leading to severe illness or death

Attorneys for the plaintiffs may argue that the manufacturer failed to adequately warn the medical community and the public regarding the risks of Viagra and that the company was irresponsible in its widespread promotion of Viagra leading to severe illness, permanent injury or death.

View Sources
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  2. Food and Drug Administration. (October 2007) Questions and Answers about Viagra, Levitra, Cialis, and Revatio: Possible Sudden Hearing Loss. US FDA Postmarket Drug Safety Information for Patients and Providers. Accessed on 01 July 2014. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106525.htm
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  9. Statistica. Worldwide revenue of Pfizer's Viagra from 2003 to 2013 (in million U.S. dollars). The Statistics Portal. Accessed on 01 July 2014. http://www.statista.com/statistics/264827/pfizers-worldwide-viagra-revenue-since-2003/
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