The U.S. Food and Drug Administration (FDA) believes the drug sildenafil citrate—sold under the brand name Revatio—might cause deadly heart-related side effects in users under the age of 17, an age group for which the drug was not indicated by the FDA.
What Is Revatio and What Is It Prescribed For?
Revatio is made and sold by Pfizer, Inc. It is prescribed to treat pulmonary arterial hypertension (PAH), a rare form of high blood pressure that affects the pulmonary artery, which carries blood from the heart to the lungs for oxygenation.
Sildenafil is more famously sold as Viagra, the drug that treats erectile dysfunction. Pfizer discovered that sildenafil can treat also treat PAH and in June 2005 received FDA approval to use the drug to treat the condition. To prevent patient confusion with Viagra, Pfizer chose to sell sildenafil under a different name and manufactures Revatio to look different from Viagra’s well-known blue diamond tablets.
Revatio is a “cGMP inhibitor” that prevents the breakdown of cGMP, a chemical that relaxes smooth muscles that are found inside the body and can’t be controlled voluntarily. When cGMP is present in the pulmonary artery, it widens the blood vessels (called “vasodilatation”) and allows more blood to flow through it. Taking Revatio supposedly vasodilates blood vessels and reduces blood pressure and PAH symptoms.
Revatio Might Cause Fatal Side Effects
The FDA believes Revatio causes the following side effects:
- Mortality in young people aged 1-17
- Low blood pressure (hypotension)
- Vision and Hearing Loss
Revatio Mortality Side Effects
On August 30, 2012, the FDA issued a Revatio drug safety communication concerning the drug’s tendency to cause fatal side effects in children aged 1-17. The agency recommended a change to the Revatio drug label to warn against prescribing the drug off-label to treat children with PAH. The FDA based its decision on a Revatio drug trial aimed at determining if it was safe for children. The trial determined that at high doses, Revatio increased the likelihood of mortality by 3.5 to one compared to low doses. The FDA also concluded that at low doses, Revatio had no beneficial effect on PAH, which is why the agency discourages the drug’s use in minors.
The two causes of Revatio mortality were pulmonary hypertension and heart failure, both consistent with PAH. The FDA’s Revatio warning does not give the number of fatalities associated with Revatio pediatric use.
On March 31, 2014, the FDA issued another drug safety communication clarifying its position on Revatio. The agency was concerned that health care professionals believed the FDA was contraindicating Revatio for minors, but this wasn’t the case. The FDA believes some people minors might benefit from Revatio treatment, but the drug isn’t indicated for them and might cause side effects.
Revatio Low Blood Pressure Side Effects
On the Revatio drug label, which was revised in August 2012, the FDA advises that Revatio can cause serious decreases in blood pressure due to its vasodilatory effects. Those who take other drugs that lower blood pressure should speak to a lawyer if any lasting side effects occurred due to blood pressure that fell below 90/50.
Revatio Vision and Hearing Loss Side Effects
Because PE5 also exists in smooth muscles found in the eyes and ears, Revatio’s PE5 inhibitory effects can also cause sensory loss in these organs. In the eyes, the resulting condition is called non-arteritic anterior ischemic optic neuropathy (NAION), which can result in decreased vision to a permanent loss of vision. Risk factors include:
- Low cup to disc ratio (“crowded disc”)
- Age over 50
- Coronary artery disease
Since October 2007, the FDA has warned that sildenafil can cause sudden hearing loss. At the time, 29 men reported suffering hearing impairment while taking the drug. Symptoms can include:
- Tinnitus (ringing)
- Temporary hearing loss
- Permanent hearing loss
RLG’s Revatio Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again.
The Revatio lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Revatio lawsuit on your behalf if necessary.
RLG will also keep you up to date on any Revatio class action lawsuits, FDA Revatio warnings, and Revatio FDA recall announcements. If you have taken Revatio and believe it harmed you, contact RLG today.