Makers of popular painkillers argue against any increases in restrictions The Associated Press
ADELPHI, Md. — The makers of Tylenol, Excedrin and other medications on Monday tried to dissuade regulators from placing new restrictions on their popular painkillers, including possibly removing some of them from store shelves. The Food and Drug Administration assembled more than 35 experts for a two-day meeting to discuss ways to prevent overdose with acetaminophen — the painrelieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications. Despite years of educational campaigns and other federal actions, acetaminophen is the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. The agency on Monday asked its experts to consider a range of options: adding a “black box” warning label to the products, lowering the drug dosage in some products, or pulling certain types of medications off the market. The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble’s NyQuil or Novartis’ Therafl u, which combine acetaminophen with other ingredients that treat cough and runny nose. The FDA says patients often pair them with a pure acetaminophen medication, like Tylenol, exposing themselves to unsafe levels of the drug. But the industry group that represents Johnson & Johnson, Wyeth and other companies defended the products Monday, saying they pose a relatively small risk to patients. Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association. The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceuticals Holdings Corp.’s Percocet, which combines oxycodone and acetaminophen. ..........>>>>........................>>>>...........http://www.dailygazette.net/De.....amp;EntityId=Ar00303
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MobileTerminal
June 30, 2009, 6:15am
Guest User
If I wanted to live in a nanny state, I'd live in Russia
I guess they feel the need to regulate simple medications for the people WHO CAN'T READ AND FOLLOW DIRECTIONS!!
When the INSANE are running the ASYLUM In individuals, insanity is rare; but in groups, parties, nations and epochs, it is the rule. -- Friedrich Nietzsche
“How fortunate for those in power that people never think.” Adolph Hitler
EXACTLY!!! Like shadow always says....you can't cure stupid!
When the INSANE are running the ASYLUM In individuals, insanity is rare; but in groups, parties, nations and epochs, it is the rule. -- Friedrich Nietzsche
“How fortunate for those in power that people never think.” Adolph Hitler
EXACTLY!!! Like shadow always says....you can't cure stupid!
This forum is evidence that you cant cure ignorant either-
Complications from non-steroidal anti-inflammatory drugs, or NSAID, known as ADVIL- ALEVE- MOTRIN have been linked to 103,000 hospitalizations and more than 16,000 deaths per year in the US, according to a study published in the American Journal of Therapeutic Assoc-
Be careful who you call stupid because you sound ignorant -
This forum is evidence that you cant cure ignorant either-
Complications from non-steroidal anti-inflammatory drugs, or NSAID, known as ADVIL- ALEVE- MOTRIN have been linked to 103,000 hospitalizations and more than 16,000 deaths per year in the US, according to a study published in the American Journal of Therapeutic Assoc-
Be careful who you call stupid because you sound ignorant -
The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceuticals Holdings Corp.’s Percocet, which combines oxycodone and acetaminophen.
The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceuticals Holdings Corp.’s Percocet, which combines oxycodone and acetaminophen.
Oh sure NOW start trying to act smart- but the fact is that Advil- Aleve- and Motrin are THE MAIN factor in thousands of deaths per year- This has been common knowledge ( to me at least ) for years-
The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceuticals Holdings Corp.’s Percocet, which combines oxycodone and acetaminophen.
Oh sure NOW start trying to act smart- but the fact is that Advil- Aleve- and Motrin are THE MAIN factor in thousands of deaths per year- This has been common knowledge ( to me at least ) for years-
Now tell the whole truth, the dosage was 4 grams and that's way over the normal dose most people take. If you take enough of anything it will make you sick.
FDA Panel Urges Cuts in Acetaminophen Dosage Concerns Over Unintentional Overdose Hazards May Change How Drug Is Marketed By DAN CHILDS June 30, 2009 An expert panel convened by the U.S. Food and Drug Administration voted today to recommend greater regulation of acetaminophen -- the most commonly used painkiller in the country.
An expert panel convened by the U.S. Food and Drug Administration voted today to recommend greater regulation of acetaminophen in response to overdose fears. (Getty Images)Specifically, the panel at the Center for Drug Evaluation and Research Joint Meeting of the Drug Safety and Risk Management Advisory Committee, the FDA's Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee has already voted to urge the FDA to switch to prescription status the strongest of the over-the-counter acetaminophen products, which contain a 1,000 mg dose.
The decision affects a variety of popular over the counter products, including the recommended dosage of Extra Strength Tylenol and other Tylenol products. The dosing instructions for Extra Strength Tylenol indicate that adults should take two 500-mg tablets every 4 to 6 hours.
Related FDA Eyes Acetaminophen's Liver RiskABC News OnCall+ Pain Management Center Home PageOnCall+ Wellness CenterThe panel will also recommend that the FDA cap the maximum dose available without prescription at 650 mg and lower the maximum recommended daily adult dose from its current level of 4,000 mg. The panel, by a narrow 17-to-20 margin, voted not to recommend pack size limits for nonprescription versions of the drug.
The decisions come in the wake of research revealing that hundreds of Americans each year experience acute liver failure as a result of taking acetaminophen and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.
Although researchers have found that the drug, the key ingredient in Tylenol products, is safe if taken at recommended levels, its prevalence as a somewhat hidden ingredient in a variety of pain relievers, fever reducers and cough medicines means patients don't realize they are taking several drugs that all contain acetaminophen.
Moreover, combining the medication with alcoholic beverages increases the risk of liver damage.
The votes are non-binding, but the FDA usually follows the panel's advice. A final decision by FDA is likely months away.
Oh sure NOW start trying to act smart- but the fact is that Advil- Aleve- and Motrin are THE MAIN factor in thousands of deaths per year- This has been common knowledge ( to me at least ) for years-
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