What’s it like to live with a transplant? The FDA wants to know

If you are a transplant patient, the federal government wants to hear from you.

The U.S. Food and Drug Administration (FDA) is the government agency that regulates the production of all medications in the United States. To determine whether a drug is placed on the market, the FDA measures whether the benefits of a drug outweigh the risks. In recent years, the FDA began including patient perspectives in the process of approving new drugs for transplant patients. To share their ideas and experiences, patients attended a public meeting on Sept. 28 and are also being encouraged to write in to the FDA. The FDA plans to use the information that patients share to approve new drugs and improve those that are already available.

At the public meeting, transplant patients shared informative and inspiring stories about living with a transplant. They also answered poll questions about their experiences, and the results were displayed live throughout the meeting for all to see.

The discussion revealed many areas of common ground. Most patients at the meeting (52 percent) had received kidney transplants, but lung, heart, liver, and pancreas transplant recipients were also present. Several themes emerged that transcended the type of organ transplant patients had received: side effects, new medical conditions, taking medicines as prescribed, and gratitude.

Side-effects of transplant medications
After receiving a transplant, patients must remain on anti-rejection drugs, also called immunosuppressants, for as long as they have their donated organs. These drugs weaken a person’s immune system, making it less likely that the immune system will try to reject the donor organ. These powerful drugs can cause serious side effects. Patients at the FDA meeting cited fatigue, tremors, gastrointestinal problems, and difficulty concentrating as some of the most common side effects. More than half (52 percent) considered difficulty concentrating to be the most troubling issue. Nearly half (46 percent) reported difficulty sleeping through the night, and more than a quarter (26 percent) said sexual intimacy issues bothered them most.

Other medical conditions post-transplant
Nearly 8 out of 10 patients had experienced depression or anxiety after their transplant. Patients said that mental health was one of the greatest consequences of organ transplant, while also one of the least talked-about. One patient had experienced post-traumatic stress disorder (PTSD) after having a transplant, and many others recalled similar experiences. Patients agreed that the medical community must increase its focus on improving procedures for diagnosing and treating depression and anxiety in transplant patients.

Infections and other health problems are also common post-transplant experiences. Because immunosuppressants weaken the immune system, transplant patients are at higher risk for diseases that might not happen in a person with a healthy immune system. More than 8 out of 10 patients at this meeting experienced bacterial infections post-transplant, nearly half had been diagnosed with cancer, and 3 out of 10 had developed a fungal infection.

Adherence to transplant medications
Adhering to the post-transplant drug regimen is critical for patients, as missing just one dose can increase the risk of organ rejection. But following the regimen isn’t easy; patients are required to take many different drugs in different doses, at different times of day, some with food and some without. As a result, patients at the meeting noted that taking their medicines consistently and correctly is a challenge. Many agreed that since immunosuppressant drugs do not produce an immediate and noticeable effect, they can be easy to forget.

Despite the notable challenges that come with having an organ transplant, an overarching theme was gratitude. Patients shared how lucky they felt to have received an organ. Those with transplanted kidneys expressed how fortunate they felt to no longer need dialysis. Patients who had received heart and liver transplants felt gratitude to be alive, as transplant is the only form of treatment for both heart and liver failure. There was a sense of camaraderie and shared understanding among audience members of both the fragility and value of a human life.

Get involved!
Do you have experiences of your own you’d like to share? The FDA wants the government, providers and patients to work together toward the goal of improving patients’ lives. As part of its Patient-Focused Drug Development initiative, the FDA encourages patients to be a part of its decision-making process by contributing a written comment through Nov. 27. Patients can share anything relating to life after transplant, but the FDA has also provided prompts for topics to write about. It isn’t every day that a federal organization requests patient input, so if you are a transplant patient, take advantage of the chance to contribute your voice to the conversation.

Another way you can get involved is by joining AKF's advocacy network, which works on behalf of patients at the federal and state levels to advocate for policies that support kidney and transplant patients.

Remember, your actions can forever shape the future of transplant recipients and those facing kidney disease. If there was anything to take away from the FDA meeting, it’s that you are never alone in your quest for health!


Ashley Ring is Manager of Public Education at the American Kidney Fund

Posted: | Author: Ashley Ring

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