Sunday, February 03, 2013

FDA panel supports increased difficulties for pain patients

Federal health advisors want new restrictions on hydrocodone, the highly addictive ingredient found in Vicodin and other widely abused prescription painkillers.

The Food and Drug Administration's panel of drug safety specialists voted to subject hydrocodone drugs to the same restrictions as narcotics like oxycodone and morphine.

The panel voted 19-10 in favor of the move, which is supported by the Drug Enforcement Agency. The FDA will weigh the vote in its decision-making process.

Hydrocodone is sold in combination pills like Vicodin, which mixes the drug with non-addictive painkillers like acetaminophen. The drug belongs to a family of drugs known as opioids, which include morphine, heroin, oxycodone, codeine and methadone.

Doctors prescribe the medicines to treat pain from injuries, surgery, arthritis and other ailments such as coughs.

Hydrocodone consistently ranks as the first or second most-abused medicine in the U.S. each year, according to the Drug Enforcement Agency.

Panelists who voted for new restrictions said it would send a signal to doctors about the potential dangers of hydrocodone drugs.

"I don't think reclassification is a panacea for the opioid abuse problem in this country, but I think it's an important step to get doctors to rethink their prescribing practices," said Mary Ellen Olbrisch, a professor at Virginia Commonwealth University.

The DEA has asked the FDA to reclassify hydrocodone as a schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled. The Controlled Substances Act, passed in 1970, put hydrocodone combination drugs in the schedule III class, which is subject to fewer controls.

An April, 2012 Drug Enforcement Administration report showed that 42 tons of pure hydrocodone were prescribed across U.S. pharmacies in 2010, enough to give 24 5-milligram Vicodins to every person in the United States.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country.

Currently a prescription for hydrocodone-containing Vicodin can be refilled five times before the patient has to see a physician again. If the drug is reclassified patients could only receive a single 90-day prescription, similar to oxycodone. The drug could also not be prescribed by nurses and physician assistants.

Panelists who voted against the classification change said it would have unintended consequences, driving addicted patients to obtain the drugs illegally.

"If prescribing decreases, illicit opioid use will increase, with dire consequences," said Dr. John Mendelson, of St. Luke's Hospital in San Francisco. "I think this is a mistake and we will be back here with other problems."

Several physician and pharmacist groups also argued that new restrictions would burden medical professionals and disrupt patient care.

"Rescheduling the products to Schedule II would create significant hardships for all - leading to delayed access for vulnerable patients with legitimate chronic pain," said the National Community Pharmacists Association, in a statement.

The FDA is not required to follow the advice of its expert panelists, though their input is often critical in its decisions.

FDA officials closed the meeting by acknowledging the difficulty of combating hydrocodone abuse, while keeping the drugs available for patients who legitimately need them.

"There is an unquestioned epidemic of opioid abuse, overdose and death in this country, an epidemic we need to address as a society," said Douglas Throckmorton, FDA's deputy director for regulatory programs.  [People are not allowed to make their own decisions about risks they will take?]


Forget hot toddies for a cold - try a flu-busting ICE CREAM instead

Might do some palliative good

 When we are struck down with a streaming cold most of us reach for a mug of comforting chicken soup or a hot toddy.  But one woman has come up with her own novel and somewhat chilling solution - a flu-busting ice cream.

The icy treat is packed full of ingredients that help to treat viral symptoms such as a dollop of honey and liquid pectin (usually found in jam) to soothe an irritated throat.

It also contains the spices of cayenne and ginger as they have anti-inflammatory properties that may help you feel less feverish and ease your aching joints.

Orange and lemon juice and included to give a super-dose of vitamin C.

Plus there's a shot of bourbon whiskey in a nod to the traditional hot toddy.

Alcohol acts as an antiseptic and could also make you drowsy making it easier to nod off after a trying day of coughing.

The recipe was the brainchild of an Ice Cream parlour owner in Ohio, according to Time magazine.  Jenni Britton Bauer said her mother and grandmother used to mix up the cocktail when she was poorly and give her a spoonful before bed.

She decided to use her skills to turn the old family recipe into an 'Influenza Sorbet,' calculating that the coldness would help numb virus pain as well.

She produced her first pot in 2004 and included a child-friendly version using a cherry concentrate instead of bourbon.  It proved such a hit that she has been selling it ever since.


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