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FDA Aims to Restrict Access to Painkiller Hydrocodone in Wake of Addiction Epidemic

The Food and Drug Administration wants stronger restrictions on a class of prescription painkillers that contain hydrocodone, the highly addictive painkiller that is now the most widely prescribed drug in the United States.In a major policy shift, the FDA recommends reclassifying Vicodin and other products that contain hydrocodone more restrictively -- from Schedule III controlled substances to Schedule II. Examples of current Schedule II drugs are OxyContin and morphine, also opioid painkillers. They are considered the most addictive, legally prescribed drugs. Schedule I is a classification reserved for illicit substances that are rarely used medically, such as LSD, heroin, ecstasy, marijuana and peyote.

The changes are expected to take place in 2014.

Earlier this year, the Centers for Disease Control and Prevention reported that prescription painkiller overdose deaths among women increased about fivefold between 1999 and 2010. Among men, such deaths rose about 3.5-fold. The rise in both death rates is closely tied to a boom in the overall use of prescribed painkillers.

Every age group has been affected by the relative ease of hydrocodone availability and the perceived safety of these products by medical prescribers, according to the DEA. Of particular concern is the prevalence of the illicit use of hydrocodone among school-aged children. The 2012 Monitoring the Future Survey reports that 1.3 %, 3 % and 3.8% of 8th, 10th, and 12th graders, respectively, used Vicodin nonmedically in the last year. A recent study has also shown that individuals who use marijuana may also represent a segment of the population that is more likely to misuse hydrocodone. The research, which was conducted by researchers at Ameritox, shows that individuals who test positive for marijuana are more likely to use prescription drugs.

In the past, FDA officials rejected recommendations from the DEA and others for stronger controls on hydrocodone, saying the action would create undue hardships for patients.

“Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs,” said U.S. Sen. Charles Schumer, who has championed the change in classification. “I’m very pleased that the FDA has heeded my call and will tighten up control of one of the most highly prescribed – and abused – drugs on the market.”

The prescription painkillers that are killing Americans are narcotics derived from the opium poppy. The substance from the flower, called opium, that contains active compounds has been used for thousands of years as medication and as a way to get high. The natural compounds, as well as those derived from them, act in the nervous system on certain receptors.

Overdose deaths are not the only statistics addressed in the CDC report. They also show that even more women are going to the emergency room for abusing painkillers. For every woman dying of an overdose, 30 end up in the emergency room. The women most likely to die from an overdose are those between the ages of 45 and 54, while women from 25 to 54 are most likely to receive emergency treatment.


When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. According to the Mayo Clinic and the Substance Abuse and Mental Health Services Administration, hydrocodone users may experience the following withdrawal symptoms when ending treatment:

Dilated pupils
Yawning and sleeplessness
Abdominal cramps
Nausea or vomiting
Runny nose
Muscle aches and pains
Excessive sweating
Rapid breathing
Rapid pulse
High blood pressure

Posted on October 25th, 2013
Posted in Opiate Drugs

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