Vicodin, Tylenol Being Reviewed by FDA

Most people have thought of Tylenol as being the safest pain reliever for as long as we can remember; however, doctors have known for some time that acetaminophen (the main active ingredient in Tylenol) can be toxic in high dosages and rare instances, causing major liver damage or even death.

Erin Allday of the San Francisco Chronicle writes that the FDA is now considering lowering the recommended dosages of acetaminophen, as well as banning several medications that combine the drug with narcotics such as Vicodin and Percocet.

Doctors say acetaminophen is safe and effective when used correctly, but people may be using far more than they should.

"The concern the FDA has is that the plethora of products, both prescription and nonprescription, can make it very easy for people to innocently take too much," said Dr. David Campen, a rheumatologist with Kaiser Permanente in Santa Clara and chair of Kaiser’s Northern California Medication Safety Committee.

For example, a single dose of Percocet can contain 650 milligrams of acetaminophen, which is just 350 milligrams short of the current recommended maximum dosage. A patient taking Percocet who has a cold might also use Benadryl, Sudafed, or NyQuil—all over-over-the-counter drugs that may contain acetaminophen—without realizing the risk of overdose. Acetaminophen is an ingredient in more than 200 prescription and nonprescription medications.

In addition, for many patients, drugs like Vicodin and Percocet lose their effectiveness over time, causing people to keep upping the dosage—sometimes without permission from their doctor. Such drugs are known primarily for their risk of addiction, but acetaminophen poisoning should also be a concern, doctors say.

A federal advisory panel recommended in June that the FDA ban prescription medications that combine acetaminophen and narcotics, and lower the dosages of over-the-counter acetaminophen. The maximum single dosage would drop from 1,000 milligrams to 650. The maximum daily dosage would be reduced to less than 4,000 milligrams; the current maximum daily dosage is 4,000 milligrams.

"Historically, makers of acetaminophen have touted it as much safer than ibuprofen and aspirin," said William Soller, executive director of the Center for Consumer Self Care at the UCSF School of Pharmacy. "Now it’s having its day in the spotlight, and that could dramatically change the analgesic market."

Acetaminophen is used primarily for pain relief and reducing fevers. Even the current recommended dosages can cause liver damage for some people. Early symptoms of acetaminophen overdose include loss of appetite, nausea, stomach pain, sweating and confusion.

Most doctors agree that it makes sense to lower the recommended dosages of acetaminophen, but some questioned the value of banning combination drugs. Vicodin is one of the most popular drugs in the country, and there’s good reason for that, said Dr. Elliott Krames, a pain specialist with California Pacific Medical Center and medical director of the Pacific Pain Treatment Center.

Medications like Vicodin are effective because the acetaminophen works with the narcotic to make it more powerful, he said.

"These (drugs) are good agents, but they have a good side and a bad side," he said. "They’re dangerous drugs if they’re overprescribed. But for a patient who has a fractured leg or who just had surgery, these agents are reasonable, they’re efficacious and they should be used."

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The Pain of Addiction

Vicodin addiction often starts innocently enough. Most people start taking Vicodin or other pain medications after surgery or an injury. But then they can’t stop. They need more to get the same pain relief. They start doctor shopping to get more pills. And the cycle continues until it takes over their lives.