Common OTC Pain Drugs Face New FDA Alerts.

Discussion in 'Fibromyalgia Main Forum' started by kjfms, Dec 20, 2006.

  1. kjfms

    kjfms Member

    From WEB MD NEWS


    Common Pain Drugs to Get New Warnings

    Acetaminophen, Aspirin, NSAIDs Face New FDA Alerts

    By Todd Zwillich

    WebMD Medical News
    Reviewed By Louise Chang, MD on Tuesday, December 19, 2006

    Dec. 19, 2006 -- Over-the-counter pain relievers used by hundreds of millions of Americans will carry stricter safety warnings under regulations proposed Tuesday by the FDA.

    Labels would warn of the potential for severe liver damage with the use of acetaminophen, the pain reliever contained in Tylenol.

    Warnings would also go on painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, aspirin, and naproxen, cautioning of a risk of gastrointestinal bleeding with overuse.

    Brand names include Advil, Motrin, and Aleve.

    Many nonprescription drugs already carry similar warnings. But FDA officials said they are seeking to make the alerts more visible and specific after reports suggesting that injury related to common pain relievers -- while uncommon -- is more prevalent than previously thought.

    "We think that warning has to be more prominently displayed," said Charles Ganley, MD, director of the FDA's office of nonprescription products. "The consumers have to be more cognizant of what they're taking for pain relief."

    There are more than 20 different forms of NSAIDs, though not all are available without a prescription. Still, together with acetaminophen, they comprise hundreds of products.

    New Labels Proposed

    The agency said it intends to require acetaminophen manufacturers to display the words "liver warning" in prominent type on packaging.

    Labels must alert consumers that severe liver damage can result if they take more than the recommended maximum daily dose, combine the pills with other drugs and those that also contain acetaminophen, or drink moderate amounts of alcohol while taking the drug.

    NSAIDs would have to carry similarly prominent warnings saying the drugs can lead to gastrointestinal bleeding in patients over 60, those with previous ulcers or bleeding, those who take a blood thinner, those taking more than one product containing an NSAID, and in patients already taking certain medications such as a corticosteroid like prednisone.

    The drugs would also continue to carry existing alerts about exceeding the maximum daily dose, taking it for longer than directed, and mixing them with alcohol, the agency said.

    Ganley said the agency believes acetaminophen to be "quite safe" but that risk of liver failure exists for the hundreds of millions of Americans who take the drugs.

    "Those rare circumstances are adding up to large numbers," he told reporters.

    Risk of Liver Failure

    The FDA delved into the liver risks of acetaminophen in public hearings in 2002.

    At the time, manufacturers projected that over-the-counter use of the drug could lead to at most 200 cases of acute liver failure per year.

    McNeil Consumer Healthcare, which manufactures Tylenol and Motrin, a pain reliever containing ibuprofen, said in a statement Tuesday it had already moved to include many of the warnings proposed by the FDA.

    The company "will continue to work with the FDA to ensure appropriate information is provided to consumers," says the statement from the company, which is owned by Johnson & Johnson. Johnson & Johnson is a WebMD sponsor.

    A study published in 2004 reported that half of all cases of acute liver failure in the U.S. were attributable to acetaminophen poisoning.

    Scientists still debate how many of those injuries stem from accidental poisonings during regular use vs. suicide attempts.

    The report's author, William M. Lee, MD, praised the FDA's move but said "it's only the start" of what the agency should do.

    U.S. vs. British Rules

    The rules would force manufacturers to label combination products like Nyquil or Tylenol PM with the word "acetaminophen."

    But many experts, including Lee, lobbied the agency to replicate rules in the U.K. limiting the drug to 16 or 24-tablet packs.

    "In the U.S. you can get 500 or 1,000 in a mayonnaise jar. Five hundred is enough to kill 40 people. In the U.K., they know it's a poison," said Lee, a professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas.

    Ganley said the agency has asked for public comment on whether it should consider limiting package quantities.

    Companies have three months to comment on the FDA's proposed regulations.

    Ganley said final rules ordering the changes are unlikely to occur by the end of 2007.

    "We are asking that people voluntarily comply in the interim," he said.


    SOURCES: Charles Ganley, MD, director, office of nonprescription products, FDA. News release, McNeil Consumer Healthcare. Lee, W. Hepatology, July 2004; vol 40: pp 6-9.

    Thanks for reading,

    Karen :)

    [This Message was Edited on 12/31/2006]
  2. Catseye

    Catseye Member

    Another thing that is not made clear is about aspirin. My dad is one of those wo takes one a day to keep his blood "thin" so he is protected against heart attack or stroke. I've tried to get him to try something else, but he won't listen. They say there is a risk of ulcers and gastric bleeding from taking aspirin all the time. I think most people think it's because it irritates the lining and you can just take some pepto or mylanta and it will go away. But here's what happens: (translation in English afterwards)

    "NSAIDs decrease the production of prostaglandins [a group of compounds that transmit messages between cells] from a component of cells called arachadonic acid by inhibiting the enzyme cyclooxygenase. Certain of these prostaglandins play a role in inflammation and the generation of pain in conditions such as rheumatoid arthritis. Therefore, by inhibiting cyclooxygenase, NSAIDs reduce inflammation and pain. However, cyclooxygenase also produces other prostaglandins that protect the lining of the stomach and duodenum against injury, notably peptic ulcer formation. At the same time most enzymes produce thromboxane, a chemical which assists in blood clotting (hemostasis). Thus, administration of NSAIDs has the undesirable side effect of causing erosions or ulcers in the upper gut, and interfering with blood clotting when they bleed."

    In English: People taking NSAIDs over long term can get ulcers and they won't know it!

    The newer NSAIDs limit only the cox 2 inflammaroty prostaglandins and are without many of the side effects of the old ones, however, cox 2 prostaglandins are important for kidney function. You just can't win, can you! Maybe ask your doctor about them. And cytotec is supposed to promote the protective lining of the stomach. And always check stools for blood, it looks black after it's been digested. Also have a blood count periodically to make sure gastric bleeding is not occurring. And liver enzymes, of course.

    If you have stomach upset frequently and take NSAIDs regularly, check it out with your doctor.

    happy xmas!

  3. kjfms

    kjfms Member

    Thanks so much for reading. Sorry it took so long for me to thank you I am a little behind in things.

    Merry Christmas,

    Karen :)
  4. kjfms

    kjfms Member

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