Notice
[Posted 06/08/2011] ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) [Zocor] because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.
BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).
RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your response to simvastatin.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
American Society of Health-System Pharmacists, Disclaimer
National Center for Biotechnology Information, U.S. National Library of Medicine
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Tuesday, June 28, 2011
Tuesday, January 18, 2011
FDA Restricts Acetaminophen in Some Products .
By ALICIA MUNDY
WASHINGTON—Federal health regulators are restricting the amount of acetaminophen in prescription painkillers such as Vicodin and Percocet because of concerns that acetaminophen overdoses are linked to thousands of cases of liver damage in recent years.
The Food and Drug Administration said Thursday it will ask manufacturers to limit acetaminophen used in combination prescription drugs to 325 milligrams. The agency is also asking drug makers to add the strongest warning—a black box—to their labels about the possibility of severe liver damage.
Federal health regulators are asking manufacturers to restrict the amount of acetaminophen in prescription painkillers because of concerns over accidental overdoses when people combine them with over-the-counter drugs. WSJ's Alicia Mundy reports.
.Acetaminophen is a widely used pain reliever found in many popular over-the-counter medicines such as Tylenol and NyQuil, which treat headaches, sore throats, fevers and muscle aches. The dosage in Johnson & Johnson's over-the-counter Extra Strength Tylenol and other extra-strength generic versions is 500 milligrams.
FDA officials said people may accidentally overdose on acetaminophen when they take it in prescription combinations with opioid narcotics and then take additional over-the-counter acetaminophen. For example, a patient using Vicodin, which contains acetaminophen, for a back injury may also ingest acetaminophen for a headache.
However, when taken in recommended dosages, "acetaminophen is a very safe product," said the FDA's Sandra Kweder, deputy director of the office of new drugs.
Acetaminophen overdoses connected to prescription combination painkillers account for nearly half of all cases of acetaminophen-related liver failure in the U.S., many of which result in liver transplant or death, FDA officials said.
The FDA said companies will phase in lower doses of acetaminophen in their prescription combinations over the next three years.
The FDA isn't taking any action at present on over-the-counter medicines. "We're continuing to consider a full spectrum of options for over-the-counter products," Dr. Kweder said.
A spokeswoman for Johnson & Johnson declined to discuss possible changes to over-the-counter Tylenol.
The company also makes three prescription combinations using acetaminophen. Two contain 325 milligrams of acetaminophen, while a third, Tylox, has 500 milligrams of that drug, said J&J spokesman William Foster. "With Tylox, we are evaluating our next steps and will discuss with FDA," he said.
The FDA move stems from a June 2009 advisory committee meeting in which the agency's outside experts on pain medicines and drug safety voted overwhelmingly for a black-box warning on Vicodin and the other combination painkillers.
The panel split on whether Vicodin and Percocet should be pulled from the market.
One of the panelists from that meeting, neurologist John Markman of the University of Rochester Medical Center, said, "The FDA struck a great balance in their decision not to pull the medicines." Dr. Markman, who runs the university's neuromedicine pain center, added, "They are very necessary in palliative care, in end-of-life care, and treating chronic pain."
The FDA considered an outright ban on the combination medicines, but rejected that, said Dr. Kweder.
Write to Alicia Mundy at alicia.mundy@wsj.com
Copyright 2011 Dow Jones & Company, Inc. All Rights Reserved
WASHINGTON—Federal health regulators are restricting the amount of acetaminophen in prescription painkillers such as Vicodin and Percocet because of concerns that acetaminophen overdoses are linked to thousands of cases of liver damage in recent years.
The Food and Drug Administration said Thursday it will ask manufacturers to limit acetaminophen used in combination prescription drugs to 325 milligrams. The agency is also asking drug makers to add the strongest warning—a black box—to their labels about the possibility of severe liver damage.
Federal health regulators are asking manufacturers to restrict the amount of acetaminophen in prescription painkillers because of concerns over accidental overdoses when people combine them with over-the-counter drugs. WSJ's Alicia Mundy reports.
.Acetaminophen is a widely used pain reliever found in many popular over-the-counter medicines such as Tylenol and NyQuil, which treat headaches, sore throats, fevers and muscle aches. The dosage in Johnson & Johnson's over-the-counter Extra Strength Tylenol and other extra-strength generic versions is 500 milligrams.
FDA officials said people may accidentally overdose on acetaminophen when they take it in prescription combinations with opioid narcotics and then take additional over-the-counter acetaminophen. For example, a patient using Vicodin, which contains acetaminophen, for a back injury may also ingest acetaminophen for a headache.
However, when taken in recommended dosages, "acetaminophen is a very safe product," said the FDA's Sandra Kweder, deputy director of the office of new drugs.
Acetaminophen overdoses connected to prescription combination painkillers account for nearly half of all cases of acetaminophen-related liver failure in the U.S., many of which result in liver transplant or death, FDA officials said.
The FDA said companies will phase in lower doses of acetaminophen in their prescription combinations over the next three years.
The FDA isn't taking any action at present on over-the-counter medicines. "We're continuing to consider a full spectrum of options for over-the-counter products," Dr. Kweder said.
A spokeswoman for Johnson & Johnson declined to discuss possible changes to over-the-counter Tylenol.
The company also makes three prescription combinations using acetaminophen. Two contain 325 milligrams of acetaminophen, while a third, Tylox, has 500 milligrams of that drug, said J&J spokesman William Foster. "With Tylox, we are evaluating our next steps and will discuss with FDA," he said.
The FDA move stems from a June 2009 advisory committee meeting in which the agency's outside experts on pain medicines and drug safety voted overwhelmingly for a black-box warning on Vicodin and the other combination painkillers.
The panel split on whether Vicodin and Percocet should be pulled from the market.
One of the panelists from that meeting, neurologist John Markman of the University of Rochester Medical Center, said, "The FDA struck a great balance in their decision not to pull the medicines." Dr. Markman, who runs the university's neuromedicine pain center, added, "They are very necessary in palliative care, in end-of-life care, and treating chronic pain."
The FDA considered an outright ban on the combination medicines, but rejected that, said Dr. Kweder.
Write to Alicia Mundy at alicia.mundy@wsj.com
Copyright 2011 Dow Jones & Company, Inc. All Rights Reserved
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