Hydrocodone (Vicodin)

Hydrocodone: important Information.

2008-04-14T05:08:00.000-07:00

FDA is issuing this public health advisory to alert patients, caregivers, and healthcare professionals to important information on the safe and appropriate use of Tussionex Pennkinetic Extended-Release Suspension. Tussionex is a prescription cough medicine containing hydrocodone and the antihistamine, chlorpheniramine that is made to be given every 12 hours (“extended-release”). Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems and death when given above or more frequently than the recommended dose. Tussionex should not be used in children less than 6 years old.

FDA is highlighting the following important information on the safe use of Tussionex:
Do not give to children less than 6 years old. FDA has received reports of death due to respiratory depression with use of Tussionex in patients less than 6 years old.

Healthcare professionals should not prescribe and patients should not take Tussionex more often than every 12 hours. Taking this cough medicine more often than every 12 hours may result in a narcotic overdose. Too much hydrocodone can cause life-threatening breathing problems and death. If the cough is not controlled when taking Tussionex every 12 hours, talk to your doctor before taking more.

Healthcare professionals who prescribe and patients who use Tussionex should be aware of the signs of hydrocodone overdose including the following: trouble breathing; slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients, parents, or caregivers should get medical attention right away.

Patients and parents should use a device designed to accurately measure Tussionex. Household teaspoons or tablespoons vary in size and can result in giving too much of the medicine. Use a syringe or spoon specifically designed to measure liquid medicine.

FDA has received reports of death and life-threatening side effects in patients, including children, who have received Tussionex. The reports indicate that doctors have inappropriately prescribed this medicine for patients less than 6 years old and at doses more frequent than every 12 hours. In addition, parents and caregivers have given this medicine too frequently and have not carefully measured the suspension, resulting in overdoses. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening breathing problems and death.

FDA has worked with the manufacturer of Tussionex Pennkinetic Extended-Release Suspension, UCB, to update the label, including information that Tussionex is not to be prescribed or used in children less than 6 years old and the need for accurate measurement and dosing.

There are cough products containing hydrocodone that can be given every 4 to 6 hours. FDA is reviewing safety information for these products and will provide updates as new information is available.

Two tablets of hydrocodone/acetaminophen work better...

2008-03-05T16:54:00.000-08:00

Postsurgical pain can be effectively treated with combination of hydrocodone and acetaminophen.

The researchers studied 163 patients after bunionectomy and divided them into 3 groups: first group received 2 tablets of extended-release hydrocodone/acetaminophen every 12 hours; the second - 1 active tablet and 1 placebo tablet every 12 hours; the rest of patients received 2 placebo tablets every 12 hours.

"Two tablets work much better as compared with 1 tablet," said Andrea Best, MD, Global Project Head, Abbott Pain Care, Abbott Laboratories, Abbott Park, Illinois, United States. Either 1 or 2 tablets is enough to be superior to placebo in relieving postsurgical pain.

In the first 12 hours, those given placebo improved less than 50 points on the 450-point scale; patients taking 1 tablet of active treatment and 1 placebo tablet improved by 200 points; those receiving 2 tablets of hydrocodone with acetaminophen achieved a 350-point improvement.

There were no serious side effects related to the drugs, Dr. Best reported. Only 2 serious adverse events took place, but they have been caused by immobility after the surgery.

Hydrocodone-Vicodin

2007-08-27T00:57:00.000-07:00

Oklahomans use a lot of them. And, their use is increasing at a staggering rate. According to statistics from the U.S. Drug Enforcement Administration, the percentage of Oklahomans using five of the most common painkillers — codeine, hydrocodone, meperidine, morphine and oxycodone — jumped 145 percent from 1997 to 2005. That’s much higher than the national increase of 90 percent.
What is fueling this increase?
According to Dr. Jack Beller, past president of the Oklahoma State Medical Association and an orthopedic surgeon in Chickasha, the increase can be attributed to the state’s aging population, as well as an increased emphasis by doctors on pain management.
It’s a vicious cycle. Chronic pain is a terrible burden for anyone to bear. But, dependence on painkillers also is a burden. Some prescription painkillers — like Oxycontin, which includes oxycodone — are highly addictive. A few years ago, NFL star Brett Favre admitted and was treated for an addiction to Vicodin, a painkiller of which the active ingredient is hydrocodone.
Sadly, all of the increase in the use of these painkillers cannot be attributed to legal means.
Mark Woodward, a spokesman for the Oklahoma Bureau of Narcotics and Dangerous Drugs, said his agency’s workload for prescription drug fraud has been increasing for 10 years. The state has an estimated 87,000 prescription drug addicts, he said.
There is no easy answer to what we would call a crisis. Some people need relief from the pain just to be able to function.
However, we can send out a plea to physicians to be careful and vigilant to make sure they are not being used — so called doctor shopping — by people who are addicted to painkillers and are resorting to getting them by illegal means.
Perhaps extra oversight of these prescriptions is going to be necessary to get a real handle on the problem.