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IS NOT AN   
ACCEPTABLE  
SIDE AFFECT
 
Speech given before the FDA Advisory Committee on  9/19/2002

On April 18th, 1995, my son Marcus said to me, "Oh Ma, I think I'm going to die." I told him I would never let that happen. I had no idea at that time how serious his medical condition was, or that it would continue to get worse. 
A few weeks before our son had injured his wrist. He had a severe sprain and was prescribed acetaminophen with codeine by our family physician. He took the medication for the prescribed time. When the prescription was finished, he continued to have some pain and purchased an OTC acetaminophen product. 

During this time period we spoke to Marcus frequently. These calls were to ask "How's your wrist," "How do you feel," "Are you eating?" He said his wrist didn't hurt as much but he wasn't feeling well and wasn't very hungry .When we spoke to him on the Friday before Easter, Marcus said he thought he was getting the flu. He said he was nauseous, had body aches and a temperature. We found out later that these are also symptoms of acetaminophen toxicity. At this point he purchased an OTC liquid flu remedy. On Easter Sunday he felt bad enough to go to a local hospital. After being in the first hospital for two days, Marcus was transferred to another hospital and put on the organ donor list. 
 

 mrk
On April 24th, 8 days after entering the hospital, and with no donor liver available, we stood next to our 23 year old son's hospital bed and watched and listened as he slowly slipped from our lives. I, my husband and our other two sons, watched as Marc's face drained of color when his heart stopped. Our previously healthy, happy son was gone. 

When we found out that the cause of death was liver failure due to acetaminophen toxicity , we didn't know what to think. Our search for an answer started. We found out that acetaminophen is a leading cause of drug overdose and death in the United States and the United Kingdom. We learned that the number of deaths per year are in the hundreds and the adverse events are over 100,000 per year. We also found out that fasting  was as much a factor as alcohol when  combined with  acetaminophen to cause liver failure. 

If our son or my husband and I had even an inkling that acetaminophen toxicity existed, I feel that the outcome of our story would be totally different. Perhaps no story to tell at all. 

My husband and I have made contact with other families across the country who have had family members die due to acetaminophen toxicity. They thought they were alone. This panel knows the statistics. You know they are not alone. To this day we meet people, tell them our story and still get the response "I didn't know that." We continue to meet doctors who are not aware of the frequency of 
acetaminophen toxicity .My husband has educated our local EMS to the signs of toxicity .Most people know about stomach problems and bleeding associated with NSAIDS. Why aren't they aware of acetaminophen and liver problems? 

We've taken on the project of trying to educate as many people as we can,  but it should be the responsibility of the manufacturers to educate consumers.  With yearly profits in the billions from acetaminophen products alone, I feel that the funds are available for consumer education. 

Commercials for prescription drugs warn of possible side effects and to consult your physician. You have the guidance of your doctor. With OTC products you are on your own. If companies are permitted to advertise their products, they should be required to inform people that fasting, alcohol and pre-existing liver problems can lead to liver damage, liver failure and death. It's their responsibility. There's a phrase that makes me sick. The phrase is "Risk, benefit ratio." It seems that it is acceptable that a number of people will die if you sell a certain amount of medication. Death is not an acceptable side effect. There's no acceptable ratio when one of those people is your loved one and important information was withheld. Information that has been known for 20 years. 

I know this panel will do what's right. You have to. You can't allow more innocent men, women and children to suffer from the adverse effects caused by acetaminophen. Seven years have passed since Marcus' death. Don't let another year pass and more families go through the unbelievable pain and sorrow that our family has had to endure. 

Something positive has to result from such an unnecessary death as our sons. In his  memory we have given out seven scholarships in his name at his high school. Another tribute would be to stop additional suffering due to the greed and indifference to consumers by the manufacturers of acetaminophen products. 

 
 
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