Prescribing a high dose of the drug Revatio to treat children with pulmonary arterial hypertension (PAH) increases the risk of death, according to a recent pediatric clinical trial. After the Food and Drug Administration (FDA) received the results of the clinical trial it released a statement recommending that children not use Revatio. Even though the FDA never approved the drug as a treatment for children with PAH, it was still being used in that capacity for some patients.
People with PAH suffer from hypertension due to difficulties with pumping blood through the lungs. The pulmonary artery transports blood into the lungs. The arteries in the lungs of PAH patients are constricted. As the heart and pulmonary artery work harder to push blood through the narrow arteries in the lungs it creates hypertension. The amount of blood and oxygen circulating throughout the body becomes insufficient if the pulmonary artery cannot effectively push enough blood through the lungs. PAH is a disorder that can get progressively worse over time. Visit our Maryland personal injury attorney page.
Symptoms of PAH include shortness of breath and fainting during physical activities such as exercise. These symptoms occur when the body isn't getting all of the oxygen it needs because enough blood isn't passing through the narrow arteries in the lungs. Other symptoms are a rapid heartbeat, fatigue, dizziness, chest pain as well as swollen legs and ankles. There is no cure for PAH but patients receive treatment to help alleviate some of the symptoms.
Adults and children from 1 to 17 years old use Revatio to treat PAH. Revatio is a drug that improves the ability for people with PAH to exercise and slows down the rate at which the disorder progresses. Revatio decreases the amount of pressure used by the pulmonary artery. A substance in Revatio known as sildenafil enlarges the blood vessels in the lungs which makes it easier for the pulmonary artery to carry blood into the lungs. When the blood vessels widen the body gets more of the oxygen it needs and this lessens the severity of other symptoms associated with PAH.
The initial treatment phase of the clinical pediatric trial lasted for 16 weeks. Two hundred thirty-four patients from the ages of 1 to 17 years old received a range of low, medium and high doses of Revatio three times per day. The purpose of the clinical trial was to measure the extent to which Revatio affected the children's ability to exercise.
After the initial treatment finished the patients continued to take the same dose of Revatio for an additional 16 weeks. The doses of Revatio were adjusted as deemed necessary for each patient as researchers continued to track the progress of patients for 3 years. There was no improvement in exercise ability for children who took low doses of Revatio. The patients who received high doses of Revatio were at greatest risk of dying from PAH-related causes. If you or a loved one has been harmed as a result of using a prescribed drug in Virginia, please visit our Virginia personal injury attorney page for more information.
Pfizer, the manufacturer of Revatio, will include a new warning label for the drug. The warning label will recommend Revatio not be prescribed to children and will list the risks the drug poses to children. The FDA recommends that children stop using Revatio while under the supervision of a physician. The FDA has also told Pfizer that it needs to evaluate the drug's effect on adults with PAH.
