August 2012 Pain Research Updates
FDA Cracks Down on Unapproved Oxycodone
The US FDA has notified companies to cease the manufacture and distribution of unapproved single-ingredient, immediate-release oxycodone drugs in oral dosage forms, according to a recent notice in the Federal Register.1 This action is the latest effort by the FDA to remove all unapproved drugs from the market since the founding of the Unapproved Drugs Initiative in 2006.
Oral formulations of oxycodone—including capsules, tablets, and oral solutions—that are not FDA approved cannot be legally marketed in the United States because these drugs have not been evaluated for effectiveness, safety, appropriate labeling, manufacturing quality, and warnings and dosing information.
“Improper labeling and use of oxycodone can lead to overdose and death,” according to a statement from the FDA. “[We recognize] that opioid medications are associated with prescription drug misuse, abuse, and addiction, which have resulted in an increase in injuries and deaths across the United States over the last 10 years.”
Companies affected must stop manufacturing the unapproved products within 45 days and must stop shipping the products within 90 days. Those companies that continue to manufacture and distribute unapproved single-ingredient, immediate-release oral oxycodone formulations are subject to seizure, injunction, or other administrative or judicial proceedings.
Physicians seeking more information can contact Astrid Lopez-Goldberg, Center for Drug Evaluation and Research, at (301) 796-3485 or e-mail firstname.lastname@example.org.
Fibromyalgia Misconceptions May Lead to Treatment Delay
Patients living with fibromyalgia (FM) inaccurately feel society views them in a negative light, according to a recent study jointly conducted by the American Chronic Pain Association (ACPA) and Forest Laboratories Inc.2
The study included 1,214 FM patients and 1,022 adults from the general population. According to the survey results, 41% of the general public believed patients living with FM are courageous, while only 17% of patients with the disease felt society viewed them this way.
Penney Cowan, founder and executive director of ACPA, and an FM patient herself, acknowledged the challenges facing those with the disease and the misconceptions that surface from both sides. “Many people in the general population have misperceptions about the impact fibromyalgia can have on people’s lives. This lack of understanding may lead people with fibromyalgia to delay seeking help and receiving an accurate diagnosis.”
According to the survey, 77% of FM patients waited up to three years before seeking help from a healthcare provider. Additionally, 70% of surveyed patients thought their symptoms would eventually go away, which led to their hesitation in seeking treatment.
Findings from the study also revealed how the disease impacts everyday activities, such as vacuuming, doing yard work, or house cleaning, with 61% of patients with FM symptoms reporting difficulty in these tasks. Romantic intimacy also suffered among those patients with FM, especially among men (56%) who often found that it was more difficult for them to become physically intimate with their partner. Decreased income, missed work, increased sick time, and missed career opportunities were also attributed to FM symptoms.