Recreational Use of Prescription Drugs Among Teens

Twenty percent of high school students in the United States have taken a prescription drug, such as OxyContin, Percocet, Vicodin, Adderall, Ritalin, or Xanax, without a doctor’s prescription, according to the 2009 National Youth Risk Behavior Survey (YRBS). This is the first year the survey assessed prescription drug abuse among high school students. The 2009 YRBS shows that many high school students engage in risk behaviors that are harmful to their overall health and increase their risk of disease and injury.

The Centers for Disease Control (CDC) and YRBS’s recently released issue brief, “Unintentional Drug Poisoning in the United States” highlight a serious public health problem with non-medical use of prescription drugs. The issue brief points out that drug overdose rates have risen steadily in the United States since 1999, with most of the increase due to prescription drugs.

Data from the Drug Abuse Warning Network (DAWN), operated by the Substance Abuse and Mental Health Services Administration (SAMHSA), estimate that in 2008 people 12-20 years old accounted for an estimated 141,417 (14.5 percent) of the 971,914 emergency department visits for nonmedical use of pharmaceuticals. These numbers do not include suicide attempts.

“Our Nation faces many public health threats that deserve our immediate attention. Among them, there is the pressing reality of drug overdoses. Teens and others have a false assumption that prescription drugs are a safer high,” said Grant Baldwin, PhD, MPH, Director of CDC’s Injury Center Division of Unintentional Injury Prevention. “These data and that from other sources show us that prescription drug misuse is a significant problem in both adolescents and adults.”

The CDC recommendations in the issue brief are based on promising interventions and expert opinion to help health care providers, state and federal agencies, as well as private insurance providers and pharmacy benefit managers, to better understand the impact and cost of unintentional poisoning. CDC continues to respond to this problem through surveillance activities, epidemiologic research, and evaluation of interventions with the greatest promise of creating a public health impact.

Source: CDC, June 3, 2010

New OxyContin Formulation Designed to Discourage Abuse of the Drug

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.

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.

New Crohn’s Disease Treatment Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved a new medicine called Cimzia for the treatment of Chron’s disease. The drug is manufactured by UCB, Inc., and is known as a tumor necrosis factor (TNF) blocker. It is used to reduce the signs and symptoms of moderately to severely active Crohn’s disease in adult patients who have not been helped enough by usual treatments.

Crohn’s disease is a condition that causes inflammation of the gastrointestinal tract, and most commonly occurs at the lower end of the small intestine. Typical symptoms include diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs. The disease affects more than 1 million men and women worldwide. It has no cure and its cause is unknown.

"Crohn’s is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA’s Center for Drug Evaluation and Research. "This drug works to reduce the signs and symptoms of Crohn’s, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals."

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

The most common side effects of Cimzia are headache, upper respiratory infections, abdominal pain, injection site reactions and nausea.

Patients taking Cimzia are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because Cimzia affects the immune system, it can lower the body’s ability to fight infections, such as tuberculosis and other opportunistic infections. Cimzia is a blocker of TNF (tumor necrosis factor) and may cause lymphomas (a form of cancer) and other malignancies. Although an increased risk of tumors was not seen in studies of Cimzia, the modest size and relatively short duration of the controlled studies prevents any firm conclusion. Post-marketing studies and clinical trials will be required to obtain long-term safety data.

Patients taking Cimzia should be educated about how to identify an infection and be instructed to contact their health care professional at the first sign of infection while on Cimzia. In cases of serious infections, the drug should be discontinued immediately.

FDA Approved Humira for Chron’s Disease

The Food and Drug Administration (FDA) today approved Humira (adalimumab) to treat adult patients with moderately to severely active Crohn’s disease, a chronic inflammatory disease of the intestines, which affects an estimated one million Americans.

Humira is a human-derived, genetically-engineered monoclonal antibody (a protein that can be produced in large quantities in a manufacturing plant). The product acts to reduce excessive levels of human tumor necrosis factor (TNF) alpha, which plays an important role in abnormal inflammatory and immune responses.

The labeling includes a boxed warning about potential serious adverse events.

Source: FDA