Levitra Recent News

Levitra was the brand name for Vardenafil. It was an erectile dysfunction (ED) drug that helped men achieve and sustain an erection. Levitra was similar to other ED drugs, such as Cialis (tadalafil) and Viagra (sildenafil). Bayer Pharmaceuticals, the original manufacturer of Levitra, submitted the drug to the U.S. Food and Drug Administration (FDA) for approval in 2003. The FDA officially approved the medication on August 19, 2003.

Levitra is a PDE-5 inhibitor (Phosphodiesterase type 5 inhibitor). This class of drugs works to increase blood flow to the penis. Like other drugs that help with erectile function, Levitra blocks an enzyme that inhibits the brain's creation of nitric oxide.

Nitric oxide increases blood flow within the blood vessels of the penis. For men who have a problem gaining an erection, Levitra significantly helped them enjoy sexual activity.

Many patients took Levitra for years. The drug was on the market from 2003 until 2018, when Bayer discontinued it. The company said they did this for business reasons. However, there is evidence that Levitra had severe side effects, including deafness and heart attack.

Here, we'll offer a brief history of Levitra, from when it hit the market until Bayer discontinued the drug in 2018. Generic versions of this medication are still available. We'll explain what to do if you suffer harm after taking one of these drugs.

Side Effects and Risks of Levitra

Shortly after the FDA approved Levitra, the agency began to issue safety alerts about the drug. Specifically, the FDA ordered Bayer and other manufacturers of Vardenafil, such as GlaxoSmithKline, to add black box warnings to their products' labels.

The FDA has concerns over some of the adverse side effects of Levitra. Clinical trials found the following side effects:

• Low blood pressure (hypotension)
• Sudden hearing loss
• Dizziness and fainting
• Heart attack and stroke

The agency also warned people taking Levitra for the treatment of erectile dysfunction to be careful of specific drug interactions. For example, people with heart disease or high blood pressure (hypertension) should avoid taking Levitra and other ED medications.

The same is true for patients taking nitrates. Nitrates already work to lower blood pressure. When a patient takes them with Levitra, there is an increased risk of hypotension.

August 29, 2022: Citizen Petition to FDA Regarding the Reason Bayer Discontinued Levitra

In 2022, the FDA received a letter from Respira Therapeutics, Inc. The company lodged a citizen petition with the FDA demanding to know why Bayer discontinued the ED drug Levitra. The petition alleged that the drugmaker stopped selling Levitra because it was dangerous and ineffective.

Bayer Pharmaceuticals had already told the Food and Drug Administration that they discontinued their ED medication for business reasons. The drug manufacturer said it had nothing to do with its safety or effectiveness on three occasions. However, the FDA conducted an independent investigation.

The FDA confirmed that Bayer removed Levitra from the market for business reasons. It was not due to the drug's safety or effectiveness.

March 22, 2018: Bayer Pharmaceuticals, Inc. Discontinues Levitra

Bayer's patent on Levitra would expire on July 3, 2023. However, the drugmaker discontinued the drug on March 22, 2018. The company notified the FDA that it was discontinuing the drug for business reasons.

Many suspected that Bayer stopped selling Levitra for safety reasons. There was evidence showing that Levitra may cause adverse side effects, such as:

• Heart attack
• Hypotension
• Sudden hearing loss

The drugmaker and the FDA confirmed that the discontinuation had nothing to do with safety concerns. The FDA would later confirm this in its response to a citizen petition in 2022.

October 18, 2007: Levitra Labeling Changes

The FDA announced that the manufacturers of the erectile dysfunction (ED) drugs Cialis, Levitra, and Viagra must change their labeling. The FDA instructed the drugmakers to display information on their drugs' potential risk of sudden hearing loss more prominently. The agency also ordered the drug companies to guide consumers on what to do if they experienced sudden problems with their hearing.

The labeling changes resulted from several cases where patients taking Levitra reported sudden hearing loss, sometimes with dizziness and ringing in the ears. The FDA advised patients taking these ED drugs to immediately stop taking the drug and seek prompt medical attention if they experienced these severe side effects in an official FDA Announcement.

July 12, 2006: FDA Warns Consumers About "Dietary Supplements" Promoted for Sexual Enhancement

The FDA warns consumers about supplements sold on Amazon.com and others, promoting them as dietary supplements to treat erectile dysfunction and enhance sexual performance.

The FDA stated that the supplements were illegal. They contained harmful, undeclared ingredients. These ingredients were similar to the active ingredients in Levitra.

The supplement manufacturers and Amazon failed to list these ingredients on their products. Therefore, consumers were unaware of the dangerous interactions these products could have with other medications.

The FDA would later send another warning letter to Amazon regarding the marketing and sale of these products on July 26, 2021.

February 14, 2006: Study Shows Levitra May Help Protect Against Heart Attack and Stroke

In the years after Levitra hit the market, some people claimed that the drug could cause a heart attack or stroke. Levitra can cause a sudden drop in blood pressure. This was especially true when patients took the drug with other prescription medications.

However, a study by researchers at Virginia Commonwealth University showed that the opposite may be true. The study indicated that Levitra and other ED drugs may protect a man from suffering a stroke or heart attack.

October 20, 2005: Public Citizen Calls on FDA to Require New Warnings for Erectile Dysfunction Drugs

Public Citizen, a national non-profit, petitioned the FDA to require black box warnings on Levitra. The group asked that Bayer warn doctors and patients about the drug's risks. They were concerned with possible vision loss from erectile dysfunction drugs, including Levitra.

The group asked that Bayer add this warning to the drug's package insert. It also asked that the warning be a black box warning.

What To Do if You Get Sick After Taking an ED Drug

If you or your partner took Levitra or another ED medication and got sick, you have options. First, see your healthcare provider. Once you visit your doctor, contact a personal injury lawyer. You may have a claim against the drug manufacturer, pharmacy, or your doctor.

If you become sick due to Bayer's failure to warn of certain risks, you can file a product liability lawsuit against them. If, however, you believe your doctor was negligent in not telling you about the drug's risks, you may need to pursue a medical malpractice claim.

Either way, contacting a product liability attorney to discuss your case is best. Visit FindLaw.com's attorney directory to find a lawyer near you.