Usa Announces Restrictions For Prescription Painkillers
The U.S. government announced on Thursday that will restrict medical prescriptions
to one of the country's most popular painkillers. According to the alert, the drug can lead patients to an overdose of acetaminophen - the active ingredient in many pain relievers such as Tylenol, which combats the symptoms of pain and fever.
The American agency for the control of medicines (FDA) has not, however, the ban on pills like Percocet and Vicodin (normally sold on prescription), following the recommendation of an advisory board in 2009. Instead, manufacturers of drugs, which combine narcotics with acetaminophen, have three years to reformulate products or to stop producing them altogether.
With the new rule, the pills can not contain more than 325 milligrams of acetaminophen - half of what is found in many of them today. The rule, however, does not apply to products sold without prescription, like the well-known Tylenol, which has more than 325 milligrams of acetaminophen allowed.
The FDA will also require more explicit labels on medicines on the risk of overdose with acetaminophen. "The FDA made this decision to make medicines that require a prescription and contains acetaminophen are safer for patients," said Sandra Kweder, deputy director of the new department of the organ.
Acetaminophen, also known as acetaminophen and APAP, is one of the most popular drugs in the world. In 2005, Americans consumed 28 billion doses of drugs that had the substance in its composition. And drugs that combine acetaminophen with morphine, like codeine, oxycodone and hydrocodone, are prescribed more than 200 million times each year.
The problem, said the organ that makes the control of drugs, is that many patients, without any notion of the content of acetaminophen, also make drugs sold over the counter like Tylenol, and are exposed to side effects that can be dangerous.
By the same doses of acetaminophen recommended by doctors can cause damage to health. More than 400 people are killed and 42,000 are hospitalized each year in the United States because of an overdose.
Overdose usually happens when the patient ingests a drug based on acetaminophen for back pain, another for migraines and sometimes even a third medication for symptoms of cough and flu.
FDA regulators for decades trying to reduce the rate of acetaminophen, but very little had been done until June 2009 when a group of national experts voted unanimously to propose to prohibit the manufacture of medicines that combine acetaminophen with narcotics.
Sandra Kweder said on Thursday that the ban would not 'cause inconvenience to patients with pain "and that the limit of 325 milligrams would not diminish the power of analgesic medication. "We do not think we are making these products less effective," she said. "The amount of acetaminophen in these products is growing slowly over the years."
The Dr. John Markman, director of pain management center of the medical department of the University of Rochester, praised the decision and said that if the ban was not the patients could be taken to ingest other combinations of drugs as risky as this.
But William Lee, professor in the interim Southwestern Medical School in Dallas, hoping that the FDA could ban the drug combinations such as Percocet and Vicodin because patients with chronic pain end up taking more pills, while gaining resistance component of morphine without realizing that higher doses of acetaminophen are dangerous.
The agency has delayed action against the counter remedies, which would require a regulatory process more cumbersome and would take much longer in comparison to the decision on prescription drugs.
"We have not made a decision on what action or what measures will be taken in relation to products sold over the counter," Kweder said in a press conference. "We are still considering what our options accordingly."
Pending the decision of the FDA, drug manufacturers "can voluntarily choose not to produce extra-strong formula," said Kweder.
But Marc Boston, spokesman for Johnson & Johnson, said the Tylenol and other drugs dosage stronger "are safer alternatives for many patients."
Sidney Wolfe, director of health research group Public Citizen, said the government's inactivity with respect to high dosage of drugs sold over the counter is unjustifiable. "It's been a year after the meeting of the advisory board," he said, "What are they doing?"
Abbott Laboratories is a manufacturer of Vicodin with doses of acetaminophen at 500, 650 and 750 milligrams - all of them above the new limit. "Abbott is reviewing the guidance of the FDA and will consider how to proceed," said Elizabeth Hoff, a spokesman for the company.
by: Stiven Benson
Your Front Door Can Make A Big First Impression Free Cna Training Certificate Confirmation Benefits Of Implementing Erp Solution Things You Need To Know About Psychostimulant Fitness Trainer - Workout Ice Cream Makers The Growing Field Of Dentistry Do I Need A Will? The Best Remedy For Cellulite Making Your Ex Come Back Nice Steps To Get Your Ex Boyfriend Back How Do I Get Him Back Some Particular Attitude To Change In-order To Get Him Back Miracle Mind Method Getting Back Together After A Breakup : Making Up With Your Ex With Just A Simple Approach