MAGNUM’s Years of Concern Regarding Acetaminophen & OTC Pain Medicines Supported by New FDA Labeling

Illustration By Michael John Coleman © MAGNUM, Inc.

WASHINGTON, DC-(SUNDAY, MAY 31th, 2009)-Anyone who has suffered from rebound headaches (AKA-Medication Overuse Headache) understand how important something that sounds so small as our government stepping in and improving labeling of the easy to access over-the-counter medications.  Many reading this who suffered for years before learning this annoying interloper (rebound) adding to their Migraine misery could have been avoided with a better national awareness effort.  More important, many might not have suffered through rebound pain if better labeling by the FDA would have appeared sooner.

That was the then, this is now, so we are happy to report the Food and Drug Administration (FDA) have advised the manufactures of over-the-counter (OTC) pain relievers in addition to fever reducers they must revise the labeling to include warnings about potential safety risks associated with these popular and effective medications. These risks include internal bleeding and the one MAGNUM has written quite a bit about over the years--liver damage.

Final Rule Issued
 
According to the FDA on April 28, 2009 a final rule was issued.  The Food and Drug Administration (FDA) at that time directed that labeling be revised for both acetaminophen (Tylenol®) and nonsteroidal anti-inflammatory drugs (NSAIDs) such as Advil®. Migraine sufferer are familiar with these two classes of pain medications which are also effective in reducing fevers and relieving minor aches and pain such as non-migraine headaches and muscle aches. NSAIDs class of drugs includes aspirin, ibuprofen, ketoprofen, and naproxen. Note: naproxen is found in the new improved anti-Migraine medication Treximet®, a compounded abortive hybrid of sumatriptan and naproxen.  This illustrates how in our community care must be taken on how much of these excellent pain management tools/medications we are actually using in a given time period.  Women have an extra issue to deal with taking into account Premenstrual Syndrome OTC products, many of which contain acetaminophen and /or NSAIDs.
 
The FDA states "The final rule applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers."

Under the FDA final rule, manufacturers must:

• ensure that the labeling warns of the risk of stomach bleeding for NSAIDs and the risk of severe liver damage for acetaminophen
• ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both packages and bottles

• revise the product labeling within one year of the date the rule was issued

 For the complete article visit MigraineBlog "MAGNUM's Years of Concern Regarding Acetaminophen & OTC Pain Medicines Supported by New FDA Labeling Requirements"