The U.S. Food and Drug Administration today approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication, including OxyContin addiction.

OxyContin is made to slowly release the potent opioid oxycodone to treat patients who require a continuous, around-the-clock opioid analgesic for management of their moderate to severe pain for an extended period of time. Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often. However, people intent on abusing the previous formulation have been able to release high levels of oxycodone all at once, which can result in a fatal overdose and contributes to high rates of OxyContin abuse.

The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication. The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended.

“Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction,” said Bob Rappaport, M.D., director of the Division of Anesthesia and Analgesia Products in the FDA’s Center for Drug Evaluation and Research.

“As with all opioids, safety is an important consideration,” he said. “Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain.”

According to the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health, approximately half a million people used OxyContin non-medically for the first time in 2008.

The manufacturer of OxyContin, Purdue Pharma L.P., will be required to conduct a postmarket study to collect data on the extent to which the new formulation reduces abuse and misuse of this opioid. The FDA is also requiring a REMS (Risk Evaluation and Mitigation Strategy) that will include the issuance of a Medication Guide to patients and a requirement for prescriber education regarding the appropriate use of opioid analgesics in the treatment of pain.

Purdue Pharma is based in Stamford, Conn.

The RDD Method provides relief from those suffering from an OxyContin addiction by providing OxyContin detox. Contact us today.

FDA Press Release from www.fda.gov.

Symptoms

When someone has overdosed on the following Opiates:  Opium; oxycontin, heroin; morphine; Suboxone, Methadone®; codeine, etc.

Treatment

Detox patients hooked on street drugs often addicted to legal meds first,  study found

(HealthDay News) – Prescription medicines are the way that many drug addicts first get hooked, making these legal medicines the new ”gateway” drugs, new study findings show.

University at Buffalo researchers interviewed 75 patients hospitalized for opioid detoxification and found that 31 of them said they first became addicted to legitimately prescribed painkillers.

Another 24 patients said their addiction began when they used a friend’s left-over prescription pills or stole drugs from a parent’s medicine cabinet, while the remaining 20 patients said they got hooked on street drugs.

But the study found that 92 percent of the patients said they eventually bought illegal drugs (usually heroin) because street drugs are less expensive and more effective than prescription drugs. Their reasons for continuing to use drugs included to feel “normal,” to feel “like a better person” or to ease emotional pain and stress.

“We are seeing an increase in the number of patients addicted to prescription drugs, so we wanted to better understand how they first got hooked,” study senior author Dr. Richard Blondell, a professor of family medicine, said in a University at Buffalo news release. ”This information suggests that there is a progressive nature to opioid use, and that prescription opioids can be the gateway to illicit drug addiction. It also tells us that people who use prescriptions illegally may be at greater risk for subsequent heroin use than those who use prescriptions legally.”

The study was published recently in the Journal of Addiction Medicine. The U.S. National Institute on Drug Abuse has more about drug abuse and addiction.

– Robert Preidt

In this Peabody Award-winning edition of Vanguard, correspondent Mariana van Zeller travels to South Florida–the “Colombia of prescription drugs”–to expose a bustling pill pipeline that stretches from the beaches of Ft. Lauderdale to the rolling hills of Appalachia.

“The OxyContin Express” features intimate access with pill addicts, prisoners and law enforcement as each struggles with a lethal national epidemic.

Current.com

by The Press Association

Drug companies have been accused of conning the public by hyping up patented medicines with little new to offer while downplaying their side-effects.

An estimated 85% of new drugs offer few if any new benefits while having the potential to cause serious harm due to toxicity or misuse, a study has concluded.

The author of the research delivered a damning attack on “Big Pharma” at a meeting of sociology experts in the US.

Professor Donald Light described the pharmaceutical industry as a “market for lemons” – one in which the seller knows much more than the buyer about the product, and takes advantage of this fact.

“Sometimes drug companies hide or downplay information about serious side-effects of new drugs and overstate the drugs’ benefits,” said Prof Light, a professor of comparative health policy at the University of Medicine and Dentistry in New Jersey, US.

“Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It’s really a two-tier market for lemons.”

He alleged that the pharmaceutical industry owned companies in charge of drug testing and provided “firewalls” of legal protection behind which information about dangers or lack of effectiveness could be be hidden.

Companies were assisted by the “relatively low bar” for effectiveness that had to be crossed to get a new drug approved, he claimed.

Prof Light presented his paper, entitled “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm” at the American Sociological Association’s annual meeting in Atlanta, Georgia.

The study includes data gathered from independent reviewers which suggest that 85% of new drugs provide few, if any, new benefits.

What is Suboxone?

Used to treat users with opioid addiction, Suboxone/Subutex (Buprenorphine) is an addicting opiate drug. Approved in October 2002 by the FDA, the high-dose sublingual pill Suboxone/Subutex has also recently been introduced in European countries as treatment for chronic pain. It can be used both for chronic cancer pain as well as chronic non-malignant pain.

Why is Suboxone prescribed?

Many doctors prescribe this drug for withdrawal and/or addiction without warning the patient about the drug’s addictive nature, and the fact they are trading one opiate for another. Some Anesthesia Detox Facilities (2 facilities at this time) give it to patients for up to 6-12 weeks after the detox procedure, and approximately 99% of in-patient rehab centers are using it. These patients do well while taking the drug, but after being discharged and within 3 days, patients typically suffer from withdrawal and seek help for Suboxone/Subutex addiction.

What are some Suboxone side effects?

Suboxone side effects may include:

• Drowsiness, dizziness, weakness
• Constipation
• Headache, nausea, or vomiting
• Slow, shallow breathing
• Heavy feeling in the chest
• Mental and mood changes
• Stomach/abdominal pain
• Dark urine, yellowing eyes and skin, vision changes
• Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.
• Loss of libido
• Frequent night time urination
• Anxiety
• Depression/sadness
• Lack of interest (no “zest” for life)
• Personality changes

What are symptoms of Suboxone withdrawal?

Symptoms of Suboxone withdrawal can be very uncomfortable and cause patients to revert back to their original drug use. Suboxone withdrawal symptoms can also last up to 2-5 weeks.

• Severe anxiety, thoughts of suicide, malaise & severe depression
• Diarrhea & sweating
• Cramp-like pains in the muscles, leg kicking, convulsions
• Severe and long lasting sleep difficulties (insomnia)
• Goose bump skin (cold turkey)
• Cramps, abdominal pain
• Dehydration & fever

How do I choose a Suboxone detox program?

Talking to a trained detox or medical professional is the right first step in choosing the appropriate program. Call the Rapid Drug Detox Center at 1-888-825-1020 or contact us if you’d like to learn more.

As prescription drug abuse is on the rise, the Washington State Department of Health reports that overdoses have replaced car crashes as the leading cause of injury-related deaths. From 2003 to 2008, the rate of prescription overdoses and hospitalizations rose 90 percent.

The most prevalent drug overdose and death culprits appear to be Vicodin, Oxycontin and Methadone, all opiods. The overuse of Vicodin can lead to increased tolerance and addiction. One risk of Vicodin addiction includes liver toxicity, which increases for users without a tolerance to the drug. Oxycontin users may suffer from respiratory depression or arrest, skeletal-muscle flaccidity, blood-pressure and heart-rate reduction, coma and death.

As for Methadone, the FDA has issued a public health advisory warning that deaths and life-threatening side effects have been reported for both new users and those that switched to Methadone after being treated for pain with other strong narcotic pain relievers. The drug can cause slow or shallow breathing and change in heartbeat that may not be felt by the patient.

The trend of drug use has evolved since popular use of certain drugs each era – from LSD in the 1960s, heroin in the 1970s, crack cocaine in the 1980s, crystal meth in the 1990s to the current prescription drug abuse.

This year’s latest drug control strategy emphasizes anti-drug programs and encourages health care providers to screen for drug problems before addiction sets in, marking a change in policy. The policy requires early detection of patient drug use and database tracking of physicians that overprescribe addictive painkillers.

Policy reform also allocates drug control budget funds to a 13 percent increase in spending on alcohol and drug prevention programs. A 3.7 percent increase in addiction treatment was also approved for the budget.

The aim for policy reforms includes goals to reduce the rate of youth drug use and drug-induced deaths by 15 percent, and drug use among young adults by 10 percent. The administration also hopes to reduce the number of chronic drug users by 15 percent.

Chronic use of opiate drugs can cause a syndrome of chronic abdominal pain, vomiting, weight loss, and features of intestinal pseudo-obstruction associated with prolonged use or abuse of opiate drugs. Symptoms resolved rapidly in all patients when narcotic/opiate administration was stopped. The narcotic bowel syndrome is a clinically important and frequently unrecognized cause of chronic abdominal pain.

Opiates delay stomach emptying and slow down the normal activity of the small intestine and colon. Narcotic bowel syndrome (NBS) is a subset of opioid bowel dysfunction that is characterized by chronic or frequently recurring abdominal pain that worsens with continued or escalating dosages of opiates. This syndrome is under recognized and may be becoming more prevalent. This may be due in the United States to increases in using opiates for chronic painful disorders and addiction. NBS can occur in patients who receive high dosages of opiates by physicians unaware of the hyperalgesic effects of chronic opiates. Hyperalgesia is a condition where chronic use of opiates cause pain.

It has long been recognized that opiates affect gastrointestinal activity. These effects, known as opioid bowel (or gastrointestinal) dysfunction are manifest as constipation, nausea, bloating, ileus and sometimes pain. When pain is the predominant symptom, the condition has been termed narcotic bowel syndrome (NBS). NBS is characterized by the progressive and somewhat paradoxical increase in abdominal pain despite continued or escalating dosages of opiates prescribed in an effort to relieve the pain. This entity was first reported two decades ago in the United States. Many of these patients are experiencing the NBS and benefit from opiate detoxification. We consider this to be a rapidly emerging health problem that requires attention.

The syndrome is characterized by chronic or intermittent colicky abdominal pain that worsens when the opiate effect wears down. While narcotics/opiates may seem helpful at first, over time the pain-free periods become shorter, leading to increasing opiate doses. Ultimately, increasing dosages enhance the adverse effects on pain sensation and delayed motility, thereby initiating the development of NBS.

Although pain is the dominant feature, nausea, bloating, vomiting, abdominal distension and constipation are common. Eating can aggravate the symptoms, so when the condition lasts for weeks, mild weight loss may occur due to anorexia or a willful restriction of eating out of fear of aggravating the pain. The symptoms may correlate with delayed gastric emptying.

A common and misleading consequence of NBS is that abdominal X-rays may show signs suggestive of a partial intestinal obstruction, which in fact is due to an adynamic ileus or pseudo-obstruction. There may also be large amounts of fecal retention seen. Laboratory tests including blood count, amylase, lipase, liver chemistry and urine analyses are usually normal.

The key to the diagnosis of NBS is the recognition that chronic or escalating doses of opiates lead to continued or worsening symptoms rather than benefit. However since the symptoms are nonspecific and many clinicians are unaware that narcotic medications can actually sensitize patients to the experience of pain. Thus, continued treatment with opiates lead to a vicious cycle of pain, use of more opiates and continued or worsening pain.

NBS remains under-recognized symptoms due to lack of knowledge about the long-term effects of opiates as causes of visceral pain and GI disturbances, and difficulties in clinically distinguishing abdominal pain that results from, rather than is benefited by opiates.

Approximately 70% of our patients are addicted to opiates for pain management and the majority are on opiates due to back pain. Back pain is one of the most common reasons people see a pain management doctor and start on opiate drugs. Up to 80% of the world’s population will suffer from back pain at some point in their lives, with the lower back as the most common location of pain.

Although most episodes of low back pain last less than two weeks, research has shown that recurrence rates for low back pain can reach as high as 50% in the first few months following an initial episode or injury.

While it is difficult to resolve lower back pain, the use of acupuncture has increased dramatically in the past few decades. Placebo-controlled studies have validated it as a reliable method of pain relief. The results of a recent study published in the Clinical Journal of Pain provide further proof that acupuncture is a safe and effective procedure for low-back pain, and that it can maintain positive outcomes for periods of six months or longer. Seeking acupuncture therapy may be an answer to relieving pain without the use of opiates that can have many negative side-effects and cause addiction.

Study Shows Many People Who Are Told They Have the Disorder Don’t Meet Standard Criteria

By Charlene Laino
WebMD Health News
Reviewed by Louise Chang, MD

Many people who have been told by their doctors that they have bipolar disorder don’t really have it.

So say researchers who used a standardized, comprehensive, psychiatric diagnostic interview to evaluate 700 adult psychiatric outpatients.

About 20% had previously been diagnosed with bipolar disorder. But only 13% met the criteria, says Mark Zimmerman, MD, associate professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University in Providence and practicing psychiatrist at Rhode Island Hospital in Providence.

“In about half of patients previously diagnosed with bipolar disorder, we couldn’t confirm the diagnosis,” he tells WebMD.

There are real dangers to overdiagnosis, chief among them unnecessary exposure to mood stabilizers and all their powerful side effects, Zimmerman says. There’s also the stigmatization of having a serious, possibly lifelong mental illness.

The study is being published online by the Journal of Clinical Psychiatry and presented at the annual meeting of the American Psychiatric Association.

Why Is Bipolar Disorder Overdiagnosed?

Bipolar disorder used to be called manic depression because it is characterized by bouts of depression and bouts of mania. Patients experience dramatic mood swings between euphoria and severe depression; they may have hallucinations or delusions.

Patients with anxiety, agitation, irritability, and restlessness that does not persist are sometimes misdiagnosed with bipolar disorder, Zimmerman says.

“These could be symptoms of bipolar disorder. But they really have to be accompanied by other criteria, such as hyperactivity, feeling energetic despite just a few hours of sleep, or inflated self-esteem,” he says.

Ironically, one reason the disorder is being overdiagnosed is “because so much has been written about it being under-recognized,” Zimmerman says.

“It’s difficult to go to a lecture on bipolar disorder that doesn’t begin with, ‘Make sure you don’t miss…,’” he says. “So clinicians are loathe to miss it.”

The increased availability of medications for the treatment of bipolar disorder may also play a role in overdiagnosis, Zimmerman says. “Physicians have a tendency to diagnose something that they feel they are comfortable treating,” he says.

So what should you do if you think you’ve been misdiagnosed with bipolar disorder?

“If you’re at all uncertain about the diagnosis, speak to your doctor and make sure you understand why you’ve been given that diagnosis. If you remain unconvinced, get a second opinion,” Zimmerman says.

A Note from Rapid Drug Detox

According to several researchers, marketing tactics by the drug industry are contributing to a huge overdiagnosis of bipolar disorder.  Studies have shown evidence that fewer than half of patients who were given a diagnosis of the disorder actually had it, as reported in the Journal of Clinical Psychiatry. Their finding contradicts previous claims that the illness was underdiagnosed. Results from this study suggest that bipolar disorder is being overdiagnosed, and, given the serious side effects that the treatments can cause, patients need to be aware of this.