Painkillers Get New Warning Labels


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• APRIL 29, 2009

Painkillers Get New Warning Labels

By JENNIFER CORBETT DOOREN

The Food and Drug Administration Tuesday finalized rules requiring stronger labeling on over-the-counter painkillers warning consumers about the risks of stomach bleeding or liver injury.

The new rules apply to acetaminophen, sold as the brand name Tylenol and widely available as a generic drug under various store brand names. The rules also apply to nonsteroidal anti-inflammatory drugs, or NSAIDs. NSAIDs include aspirin, ibuprofen, naproxen and ketoprofen and are sold under brand names that include Advil and Motrin.

The FDA said manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen. Warnings will be required for cough and cold products that contain the painkillers.

Full story : http://online.wsj.com/article/SB124096899835366675.html

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I have a friend who used Tylenol daily for a chronic condition, AND she drank ... well, quite a bit. I was very worried for the health of her liver. She's on a different pain killer now (and drinks far less).

My understanding of the stomach bleeding problem is that the pain killers work through the same nervous system as that which tells your stomach when it needs to build new lining. Your stomach lining either wears or is 'eaten' by acid, which is no problem because it just 'senses' that new cells are needed and adds them on a regular basis. However, certain types of pain killers 'blunt' the nervous system including the one that tells your body when to replace the cells lining the stomach. Hence, your stomach can't 'sense' or feel that need for new cells, the lining wears down to the point where acids reach unprotected cells and ... Bleeding.

Drugs are so complicated it's a wonder ANY are released for over-the-counter sale at all.

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I live on pain killers due to a chronic long lasting pain condition for which there is no cure . I never take any painkillers on an empty stomach however, when the pain gets intolerable even with using painkillers I head for the nearest hospital emergency and get a shot of demerol which knocks me out and then I am good for at least a month before pain sets in again or I trigger it. Alcohol ... I am a cheap drunk - one glass of wine and the lights go out! :lol: In canada, it is legal to grow marijuna for medicinal purposes but you need to get a permit from the government and have a medical certificate ... it has not gotten that bad for me that I would want it but there are people that have about 6 plants just for that purpose.

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I'd guess fibro myalgia (no need to confirm), which is what my friend has. Decades ago my sister had every symptom of fibro myalgia, but that was not yet accepted as a chronic condition (my memory's a bit hazy, it might not even have been defined at the time). Doctors wouldn't prescribe pain medication on a continuous basis, so she suffered incredibly. I went over to her house one day and found her on the living room floor, curled up in the fetal position.

That was back in the day when, if doctors couldn't diagnose what you had, it must be "in your head." Can you imagine being told, essentially, "since we can't SEE any problem that means you're NOT in pain, you're imagining it?" And of course, being female and it being the era that it was, they thought it must be a "female problem," so they cut her open probably a dozen times looking for the source of the pain.

I wonder why I have such little regard for physicians? <_<

*****

Oh yeah, my friend? She was diagnosed with fibro myalgia several years ago and was told they couldn't put her on a continuous regimen of pain medicine. She had to "reason" with them to convince them that unless they could "cure" her, she was going to be in continuous pain and demanded to be properly medicated for it. I'm SO glad physicians have FINALLY come 'round on this condition.

Edited by JDoors
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  • 2 weeks later...
• APRIL 29, 2009

Painkillers Get New Warning Labels

By JENNIFER CORBETT DOOREN

The Food and Drug Administration Tuesday finalized rules requiring stronger labeling on over-the-counter painkillers warning consumers about the risks of stomach bleeding or liver injury.

The new rules apply to acetaminophen, sold as the brand name Tylenol and widely available as a generic drug under various store brand names. The rules also apply to nonsteroidal anti-inflammatory drugs, or NSAIDs. NSAIDs include aspirin, ibuprofen, naproxen and ketoprofen and are sold under brand names that include Advil and Motrin.

The FDA said manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen. Warnings will be required for cough and cold products that contain the painkillers.

Full story : http://online.wsj.com/article/SB124096899835366675.html

Good article, Peaches.

Also the OTC pain killer Aleve is actually Napraxon, or as it's also known as, Naprosyn, in a lower dosage. The purpose of all the NSAIDS are actually their anti-inflammatory effects, which then lessen the pain.

Unfortunately I am way too familiar with all of the above.

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I'd guess fibro myalgia (no need to confirm), which is what my friend has. Decades ago my sister had every symptom of fibro myalgia, but that was not yet accepted as a chronic condition (my memory's a bit hazy, it might not even have been defined at the time). Doctors wouldn't prescribe pain medication on a continuous basis, so she suffered incredibly. I went over to her house one day and found her on the living room floor, curled up in the fetal position.

That was back in the day when, if doctors couldn't diagnose what you had, it must be "in your head." Can you imagine being told, essentially, "since we can't SEE any problem that means you're NOT in pain, you're imagining it?" And of course, being female and it being the era that it was, they thought it must be a "female problem," so they cut her open probably a dozen times looking for the source of the pain.

I wonder why I have such little regard for physicians? <_<

*****

Oh yeah, my friend? She was diagnosed with fibro myalgia several years ago and was told they couldn't put her on a continuous regimen of pain medicine. She had to "reason" with them to convince them that unless they could "cure" her, she was going to be in continuous pain and demanded to be properly medicated for it. I'm SO glad physicians have FINALLY come 'round on this condition.

I was just talking to my doctor about Fibromyalgia last week. He's considering it a possibility because af all the pain I have. Tests are next week. We'll see.

Edited by irregularjoe
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  • 2 weeks later...

Yes friends,I will confirm it is Fibromyalgia with Chronic Fatigue Syndrome combined. The first 3 yrs. I was totally ambulatory - I could not move, feed myself, dress myself, walk, comb my hair, brush my teeth and anything normal people enjoy was denied to me. I took matters into my own hands to achieve a degree of wellness and live a reasonably normal life ... I travel, I walk, I am an Administrator on 2 other forums - one social and one Security as well as serving as an elected director on a multi million dollar corporation. From ambulatory I rose to achievements beyond my dreams. It can be done and one must never give up hope.

Read here a diary regarding fibromyalgia .. http://circlesoffriends.us//index.php?showtopic=147 - it may help your friends to a better understanding of this illness.

Pills are fine on a temporary basis, however, a doctor should look beyond pills and find the cause and then work on treatment. Certain pills can also kill good bacteria in the gut if taken over a long period of time ... this creates another unpleasant condition to deal with. One soon enters a cycle of taking pills to counteract reactions from pills and so forth. I suffered horribly but with total bed rest for a few years I slowly began to recover & enjoy a degree of wellness.

Thank you for your comments and interest.

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Yes friends,I will confirm it is Fibromyalgia with Chronic Fatigue Syndrome combined. The first 3 yrs. I was totally ambulatory - I could not move, feed myself, dress myself, walk, comb my hair, brush my teeth and anything normal people enjoy was denied to me. I took matters into my own hands to achieve a degree of wellness and live a reasonably normal life ... I travel, I walk, I am an Administrator on 2 other forums - one social and one Security as well as serving as an elected director on a multi million dollar corporation. From ambulatory I rose to achievements beyond my dreams. It can be done and one must never give up hope.

Read here a diary regarding fibromyalgia .. http://circlesoffriends.us//index.php?showtopic=147 - it may help your friends to a better understanding of this illness.

Pills are fine on a temporary basis, however, a doctor should look beyond pills and find the cause and then work on treatment. Certain pills can also kill good bacteria in the gut if taken over a long period of time ... this creates another unpleasant condition to deal with. One soon enters a cycle of taking pills to counteract reactions from pills and so forth. I suffered horribly but with total bed rest for a few years I slowly began to recover & enjoy a degree of wellness.

Thank you for your comments and interest.

One of the many problems facing Americans (other than the fact that heath care insurance is unavailable to 49 million people and too expensive for a lot of the rest) is the demise of the General Practitioner.

Only 2 percent of medical school students are choosing GP as a a course of study. Everything is now a specialty. The wholistic approach is almost nonexistent in modern medicine.

Personally, I have to spend enormous amounts of time just getting referrals to four different specialists, non of which are interested in knowing what else is going on with my body.

I am also a believer in alternative practices. However due to the shortcomings (greed) of the insurance companies in general and the HMO's in particular that is sometimes hard to attain. Especially when you're in constant pain.

I haven't read your diary yet, but plan to do so later. I'll post back with my comments.

I'm glad to hear that you recovered from your ailment. That gives me some hope. Thank you for sharing.

Joe

Edited by irregularjoe
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