Viagra Legal Information

Viagra (sildenafil citrate) is a phosphodiesterase type 5 (PDE5) inhibitor prescribed to treat erectile dysfunction (ED) in men. ED is a condition where the penis does not harden and expand when a man is sexually excited or when he cannot keep an erection.

The U.S. Food and Drug Administration (FDA) approved Viagra in 1998. It was one of the first oral pills to treat impotence, a dysfunction that affects millions of men in the United States.

Pfizer was the first company to manufacture Viagra. Today, there are dozens of ED drugs available, such as Cialis and Levitra. Still, millions of Americans take Viagra every year.

Clinical studies have shown that Viagra carries dangerous side effects, including:

• Vision loss
• Hearing loss
• Cardiovascular disease
• Persistent erections

This article discusses the health risks associated with Viagra. You’ll also find news, research, and legal updates on this sexual function medication.

If you’ve been harmed by Viagra or another erectile dysfunction drug, you may have a valid claim. Contact a product liability attorney near you to review your legal options and learn how to pursue compensation for your injuries. You don’t have to navigate the legal process alone—an attorney may be your fiercest advocate.

Viagra’s Limited Uses

While Viagra is effective at treating sexual dysfunction issues in men, there is little evidence that it helps women. Some doctors also prescribe Viagra for pulmonary arterial hypertension. The drug also has an off-label use for Raynaud’s phenomenon.

Viagra can help a man sustain an erection. It can even help men who typically have trouble achieving an erect penis, even with sufficient sexual stimulation. But there are certain things Viagra does not do.

Specifically, Viagra does not:

• Cure ED
• Increase sexual desire
• Protect you or your partner from sexually transmitted diseases (STDs), including HIV
• Serve as a form of birth control

Who Should Avoid Taking Viagra?

Viagra is beneficial for many men suffering from ED. But some people should avoid taking this medication.

You should not take Viagra if:

• You take nitrates such as nitroglycerin
• You use recreational drugs called poppers, like amyl nitrate and butyl nitrate
• Your healthcare professional told you to avoid sexual activity due to health problems

Always talk to your healthcare provider before taking any new medications. This applies to both prescription and over-the-counter drugs. This is especially true if you suffer from any of the following health conditions:

• Angina (chest pain)
• Heart failure
• Cardiovascular conditions
• Pulmonary arterial hypertension
• Irregular heartbeat

People with these conditions are at an increased risk of developing serious side effects from taking Viagra.

Viagra can cause a sudden drop in blood pressure to an unsafe level if taken with certain other medicines, such as nitrites, recreational drugs that contain nitrates, and alpha-blockers.

Sudden drops in blood pressure can cause dizziness, fainting, heart attack, or stroke. Even a small dose of Viagra can have a devastating impact on your health if you aren’t careful.

Tell Your Healthcare Professional You Take Viagra

Tell all your healthcare providers that you take Viagra. If you need emergency medical care for a heart problem, it will be necessary for your healthcare professionals to know when you last took Viagra.

Before using Viagra, tell your healthcare professional if you have any of the following conditions:

• Heart problems
• Uncontrolled low blood pressure or high blood pressure
• Stroke
• Liver problems
• Severe vision loss
• Kidney problems (or if you require dialysis)
• Retinitis pigmentosa, a rare genetic (runs in families) eye disease
• Stomach ulcers
• Bleeding problem
• Deformed penis shape or Peyronie’s disease
• Erection that lasted more than four hours
• Sickle cell anemia, multiple myeloma, or leukemia
• Taken a protease inhibitor for the treatment of HIV
• Taken alpha-blockers

Any of these things can cause adverse reactions in people taking Viagra. It’s also not advised to take Viagra at the same time as certain antibiotic and antifungal medications, like ketoconazole, erythromycin, or itraconazole.

Adverse Side Effects of Viagra

Men who use Viagra are at risk of developing unpleasant and sometimes dangerous side effects.

The adverse health risks of Viagra include:

• Headache
• Flushing
• Indigestion, upset stomach, and diarrhea
• Sudden vision loss
• Hearing loss
• Stuffy or runny nose
• Urinary tract infection
• Cardiovascular issues

One of the most serious side effects of Viagra is the risk of heart disease. Some men who take Viagra suffer heart attacks or heart failure. This is true for most PDE5 inhibitors.

Rarer side effects of Viagra include:

• An erection that will not go away (priapism)
• Vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green

If these side effects persist, contact your doctor immediately. You may need to stop taking Viagra and find an alternate solution.

Dangerous Drugs and Product Liability

While all medications have specific anticipated side effects, drug manufacturers must ensure their products are safe. They must also inform the medical community and the public of a drug’s known risks.

If a manufacturer fails to do these things, the courts can hold them legally responsible if patients get hurt. Under product liability law, manufacturers are liable for inadequate warnings or the unreasonably dangerous nature of a drug.

Viagra FDA Alert

In 2005, the FDA issued an alert for men using Viagra, Cialis, or Levitra. A small number of men taking the drug lost eyesight in one eye sometime after taking these drugs. This type of vision loss is non-arteritic anterior ischemic optic neuropathy (NAION).

The FDA still does not know if these drugs cause NAION since this condition also occurs in men who don’t take these medicines.

Other Vision Issues for Viagra Patients

According to the American Academy of Ophthalmology, people taking high doses of Viagra can experience other vision problems as well. The way Viagra works is by increasing blood flow to the penis. The drug turns off an enzyme called phosphodiesterase-5.

The problem is that this change interferes with an enzyme in the retina. The damage Viagra causes to these retina cells can be permanent. Men taking high doses of Viagra reported the following issues:

• Blurred vision
• Colorblindness
• Blue-tinted vision
• Light sensitivity

These symptoms lasted for up to three weeks for some patients.

Age and certain medical conditions can make you more prone to serious side effects. People who have a higher chance of vision damage include those who:

• Have heart disease
• Are over 50 years old
• Have diabetes
• Have high blood pressure
• Have high cholesterol
• Smoke
• Have certain eye problems

The FDA has approved new labels for Viagra, Cialis, and Levitra to include information on possible eyesight loss (like NAION). If you experience a loss in your eyesight, stop using these medicines and get medical help immediately.

Viagra Lawsuits and Litigation

Since the FDA approved Viagra, Pfizer has faced its share of lawsuits. Many of the claims against Pfizer involved allegations that Viagra caused:

• Heart problems
• Vision loss
• Skin cancer

The drug company has resolved most of the heart and vision loss lawsuits. But, there are still hundreds of lawsuits pending in federal court alleging that Pfizer’s ED drug causes an increased risk of melanoma (skin cancer). Plaintiffs have argued that Pfizer knew their drug caused skin cancer and failed to warn health care providers and the public.

In 2016, courts consolidated the Viagra melanoma cases into one multi-district litigation (MDL) in California. The plaintiffs in the California MDL named Pfizer and Eli Lilly in their lawsuits. In April 2020, the federal judge granted summary judgment in favor of the defendants.

The judge excluded the plaintiffs’ expert witness. Without their expert testimony, there wasn’t enough evidence to prove that Viagra caused skin cancer.

Pfizer Settles Patent Lawsuit Against TEVA Pharmaceuticals

In December 2013, Pfizer settled a long-running lawsuit against rival drug manufacturer Teva. Teva tried to submit a generic version of Viagra to the FDA for approval. Pfizer’s patent on the drug wasn’t set to expire until April 2020.

The two pharmaceutical companies arrived at a settlement on Dec. 17, 2013. According to the settlement, Teva could start marketing its generic version of the ED drug starting Dec. 11, 2017. The drug company has to pay Pfizer royalties on all sales of the generic medication.

Viagra May Help Infants with Neonatal Encephalopathy

A study in the Journal of Pediatrics found that Viagra may help infants suffering from lack of oxygen at birth. Most doctors attempt to treat this condition (neonatal encephalopathy) with therapeutic hypothermia. Only 29% of infants respond to this treatment.

Clinical trials at Montreal Children’s Hospital seem promising. This is in the first phase of research. But, researchers reported that using Viagra to help repair signs of brain damage in newborns appears to be safe and effective.

Researchers Suggest ED Drugs May Improve Men’s Heart Health

A January 2023 study shows that Viagra and other ED medications may help reduce the risk of type-2 diabetes and cardiovascular disease in men. The study looked at how various ED drugs, including sildenafil, tadalafil, and vardenafil, impact heart health in men.

All these drugs are PDE-5 inhibitors. They increase the production of cyclic guanosine monophosphate in the body, which helps relax smooth muscles. ED medications help relax artery walls, improving blood flow to the heart and circulation.

The study found that men who took Viagra and other ED prescription medications may improve their cardiovascular health. This is in direct opposition to early reports that Viagra may cause heart disease.

New Studies Show Viagra May Reduce the Risk of Alzheimer’s Disease

In February 2024, the American Academy of Neurology published a study on the use of Viagra to prevent or delay Alzheimer’s disease. The study found that men who took ED drugs, such as Viagra, were 18% less likely to develop Alzheimer’s.

The study followed participants for five years. The average age of the men in the study was 59 years old. Since Viagra increases blood flow to the brain, it cuts down on the energy neurons use in the brain. This helps prevent cognitive decline.

This study confirmed findings in a National Institute on Aging study that found that men who took Viagra reduced their risk of Alzheimer’s by 69%.

Injured by Viagra Use? Learn Your Legal Options

If you or a loved one suffered harm after taking Viagra, you may have a valid legal claim. Depending on the nature and extent of your injuries, you may be able to sue Pfizer or other ED drug manufacturers. An experienced attorney can review your case and provide valuable legal advice.

FindLaw’s directory of product liability attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with personal injury and Viagra litigation. Many law offices offer free case evaluations.