Ms. Pamela Snow
Arthritis Foundation Representative
Member, Osteoarthritis Alliance
Food and Drug Administration Joint Meeting — June 30, 2009:
Drug Safety and Risk Management, Nonprescription Drugs and Anesthetic Advisory Committee
and Life Support Drugs Advisory Committee
Statement:
Good morning, and thank you for inviting me and the Arthritis Foundation here today to give voice to the 46 million Americans with some form of arthritis. We are grateful for the increased public input into the FDA’s evaluation and assessment of drugs used for the treatment of arthritis. We believe it is important for you to hear directly from people who use these drugs to relieve the often debilitating pain and inflammation of arthritis and related diseases.
My name is Pam Snow and I am one of the 27 million Americans with osteoarthritis. I consider myself an active wife, mother and grandmother that refuses to allow the pain associated with arthritis to control my life. Seven years ago at the age of 41, I was diagnosed with osteoarthritis in both knees. I have endured two knee surgeries, lots of physical therapy and many hours of pure pain and discomfort. Today, I control my arthritis and my arthritis pain through a combination of a positive outlook, regular physical activity, weight control, and the occasional use of over-the-counter pain relievers, including acetaminophen. I know from experience the important role of acetaminophen in relieving the pain of arthritis. I, for one, take it so I can engage in the physical activity that has been proven to alleviate my arthritis pain and prevent disability.
The Arthritis Foundation serves as a resource for people with arthritis and provides them with knowledge to make better decisions. Acetaminophen is an important drug that helps many people manage their pain. However, we are well aware that some patients with arthritis frequently take acetaminophen in doses near the upper limit for safety to manage their pain. If they then use another over-the-counter medication which contains acetaminophen for cold symptoms, for example, they can easily and unknowingly exceed a safe dose level and suffer liver damage. Although we all hoped the clarified labeling regulations that went into place a few years ago would help limit or prevent this complication, it has not.
All medications have side effects, and these side effects are often related to dose. The Arthritis Foundation recognizes the importance of minimizing the risks of adverse effects from acetaminophen, but also wants the greatest number of treatment alternatives available to people with arthritis – from existing medications, to new drugs, to exercise and education programs, and access to health professionals. We believe that people with arthritis should have access to all beneficial medications as well as knowledge about their potential side effects so they can make a personal choice about the level of risk they are willing to accept to alleviate the daily impact and pain of arthritis. The continued concern over safety of arthritis pain relievers underscores the tremendous impact of arthritis on the nation, and the need for ongoing research for development of new medications, treatment and understanding of the disease.
We applaud the FDA’s plans to expand educational programs for the public and health professionals regarding risks of overdose from acetaminophen and liver damage. We hope the public education will provide appropriate instructions to patients regarding the need for careful attention of how drugs, alcohol, and even some foods interact with each other to affect the way the body metabolizes acetaminophen.
It is important to all people with arthritis that any changes the FDA makes with regard to acetaminophen will not limit the availability of this important and generally safe drug or increase its cost to consumers. The challenge for people, like myself, with chronic arthritis pain is to assess the risks and benefits and costs of any treatment accurately. I want to play an active role in decisions made about my treatment and want to be given the opportunity to be fully informed about the potential benefits and risks of all available treatment options to relieve my pain and reduce my risk of disability.
As the voice of 46 million Americans with doctor-diagnosed arthritis, I hope the FDA carefully considers the impact of your decisions on the very people it is striving to protect.
In summary, the Arthritis Foundation believes:
- People with arthritis should have access to all beneficial medications such as acetaminophen.
- The FDA and the pharmaceutical industry need to significantly increase patient education materials and appropriate warnings about side effects related to acetaminophen. It is all too apparent that this knowledge regarding serious side effects is lacking within the general population. Consumers need to be made aware of the potential side effects so they can make a personal choice about the level of risk they are willing to accept to alleviate the daily impact and pain of arthritis. The Arthritis Foundation is fully committed to working with the FDA and private industry to help communicate important information regarding the risks associated with acetaminophen. We look forward to working together to better inform the public about the appropriate uses and doses regarding this important ‘tool in the tool box’ to treat arthritis pain.
- The Arthritis Foundation strongly urges the FDA to include a consumer representative from the Arthritis Foundation on future deliberations on this topic. Arthritis pain is one of the major reasons people use acetaminophen and we bring that voice to the table.
Thank you for your time and consideration.
