In July I told you about an FDA advisory panel recommendation that the FDA remove from the market prescription combination products containing acetaminophen (such as Lortab, Percocet and Darvocet) and make the extra strength dose of over the counter acetaminophen available by prescription only. Research has raised concerns about liver damage and overdoses experienced by patients who exceed the recommended doses of these products. Those of us who feel passionately about this issue have only a brief window of time within which to submit comments before the FDA makes a decision on the issue.

These are some of my main concerns about the advisory panel's recommendations:

• Products containing acetaminophen are safe when used as directed. It is a mistake to set public policy by focusing on misuse or abuse of a product.

• Liver damage is seen with overdoses. How will reducing the maximum dosage of acetaminophen have any effect on liver damage? The current limits are perfectly appropriate when followed. If people are going to misuse a product or ignore warnings, they will continue to do so.

• According to the Consumer Health Care Products Association (a drug industry group), 80% of the deaths associated with acetaminophen and acetaminophen combination products are suicides, not accidents.

• Educational efforts could more precisely target the concerns raised by products containing acetaminophen without causing unnecessary suffering for people with acute and chronic pain.

• These changes would make it very difficult for doctors to treat their patients' acute pain after surgery or an acute injury.

• At a time when undertreatment of pain is widely acknowledged as a huge problem, banning one existing option being used to treat pain is bound to make this problem even worse.

• People suffering from chronic pain conditions know better than anyone the importance of finding an effective strategy for preventing their pain. But we all live in the real world and know just how difficult this can be for some patients. Banning combination products containing acetaminophen will increase the suffering of chronic pain patients.
  

The American Pain Foundation (APF) believes, as do I, the concerns about these drugs can be more properly addressed through education than through banning some products and increasing regulation of others. If you agree, please sign the APF petition before Sunday, September 27:

Acetaminophen: Educate, Do Not Regulate

If you feel inclined to do so, you can also submit comments directly to the FDA. Comments are due by Wednesday, September 30.

Regulations.gov: FDA Comment

If you'd like to do some additional reading to help you compose your comments to the FDA, the APF has provided links to some of its excellent resources:

• Click here to read APF’s position statement on the FDA recommendations for acetaminophen combined medications and over-the-counter acetaminophen medications.

• Click here to read the task force’s concerns about the FDA’s recommendations regarding prescription acetaminophen combined medications.

• Click here to read the task force’s concerns about the FDA’s recommendations regarding over-the-counter acetaminophen medications.

• Click here to read APF’s Question & Answer sheet on acetaminophen and opioids.

This is an important issue. Please make your voice heard.

Related Posts:
FDA Advisory Panel Recommends Removing Certain Prescription Painkillers From Market
Hint of Good News Regarding Possible FDA Ban of Certain Prescription Pain Medications

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DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.