Dear Dr. Rowe,

Thank you for bringing this important issue to our attention. I agree that there should be an extensive education and public awareness program to inform the public about how Acetaminophen is used in conjunction with their other medications, what amount they are ingesting, and why they need to be careful.  I believe it is counter-productive, however, to begin removing Acetaminophen from the shelves or banning or severely limiting its use together with another medication, specifically pain medication, before taking other steps.  You correctly state that many people believe that because something can be bought "over the counter," or OTC, there is little to no danger associated with it, which is completely wrong.  

There are several effective pain medications on the market today that contain Acetaminophen and to remove these would be a disservice to those of us who live our lives with pain.  Many non-pain medications can have a negative impact on a person's liver, in fact there are some medications that require periodic blood tests to assess a person's liver function before a new prescription can be written.  These medicines have not appeared on any list that I have seen of medicines that are in danger of being removed from use.  Is this another effort to increase the barriers that people in pain already face in their efforts to receive effective   pain medications?  If not, then why isn't the first approach one of education and awareness building?

For the past several years pharmaceutical companies market an every increasing variety of medicines and medical procedures, such as joint replacements and surgery for  weight loss, through television commercials.  I am personally appalled by these commercials as I believe medical professionals should be the target of medical marketing efforts, with a strong education element included, instead of the consumer who many times does not even hear what illness or condition the medicine on the commercial is for.  What these commercials do demonstrate, however, is the number of potential risks each of these medicines carry, some very serious and life-threatening risks.  In one case a second commercial had to be run by the pharmaceutical because the FDA did not feel the risks associated with taking it were highlighted strongly enough in the initial commercial; the product was never removed from the shelves, however. 

I apologize for the length of this comment, however after living with pain for over 40 years and knowing that there are finally some effective medications for chronic pain, it is distressing to learn that the FDA is considering the removal of an essential element of these medications even before it attempts to increase the doctor and patient education programs that could remove or reduce the risk significantly, or at least to the same degree that many other medications risk damaging the liver.  Most people who watch TV commercials or read patient information booklets that accompany prescriptions know that there is risk associated with taking any medication, and it is the doctor and the patient's responsibility to be aware of what they are and to take necessary steps to prevent or treat them, should they appear.

I will definitely write to the FDA, again, and request that they first try to limit the risk through education and building awareness among medical professionals, including pharmacists, and patients.  My previous letter to the FDA discussed the proposed Risk Evaluation and Mitigation Strategies (REMS) and how they might affect people living with pain.  We must all stay aware of current and new policies and legislation on the federal and state level, and when possible speak out for or against those that could impact our health and our lives.

Thank you for the opportunity to comment.

Dr Rowe,

     As someone living with pain everyday, the news about the threat of an acetaminophen pull from the shelves is very disturbing to me.  It's bad enough that people with pain are treated like drug-seeing criminals or hopeless drug addicts only looking to get high when we visit a doctor and discuss our pain.  Yes, there are people who go to numerous health care providers looking to get high and there are some looking to sell either their prescriptions or their medication.  But I would believe that the majority are people like me who only want to control the pain that has stopped us from living our lives.  If you simply pull these meds from the shelves, yes, you will put a dramatic halt to some prescription drug abuse, but at the same time you will plunge those of us suffering back into the dark world of daily pain.  It's bad enough that I am made to feel like a common criminal, fearing that even asking for the pain medication that works for me will become a "red flag" to some overzealous doctor or bureaucrat and cause my name to be given to a law enforcement agency.  Drug abuse is a real problem, but for people with pain, we are not addicts, we are physically dependent on these medications to continue to be productive members of society.  Maybe an educational campaign should be the best approach at this time.  Please do not act in haste in this matter.

Bill Condos