Treatment of chronic pain has changed dramatically in the last 3 years, shifting from concern about undertreating patients with chronic pain to concern about the safety of overuse of extended-release and long-acting opioid analgesics. With overdoses of prescription opioids skyrocketing and far outnumbering overdoses from illegal drugs, the FDA has decided to take action. The agency is requiring labeling changes and new postmarketing study requirements for these drugs, including oxycodone (Oxycontin), controlled-release and extended-release morphine (MS Contin and Avinza), and fentanyl patches (Duragesic). The labeling changes are being required to “combat the crisis of misuse, abuse, addiction, overdose, and death from these drugs that have harmed too many patients and devastated too many families and communities.” The updated indications for the extended-release and long-acting opioids state that these drugs are indicated “for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.” The goal of the postmarketing studies is to further assess the known serious risks of these drugs, including misuse, abuse, hyperalgesia, addiction, overdose, and death.
The FDA is also requiring additional labeling changes to fentanyl patches due to 32 accidental pediatric exposures, including 12 deaths in the last 16 years. The labeling requirements include printing the drug’s name and strength in the clearly visible, long-lasting ink on the patch, in a color that is clearly visible to the patient and caregivers. The FDA also recommends that for disposal the patch be folded in half, sticky sides together, and flushed down the toilet immediately. These labeling changes apply to both generic fentanyl patches and brand-name Duragesic patches.
The FDA has approved the first generic version of the anticancer drug capecitabine (Xeloda), an oral chemotherapy agent used to treat metastatic colorectal cancer and metastatic breast cancer. The new generic is manufactured by Teva Pharmaceuticals while the branded product is manufactured by Roche. Two years ago, Roche settled a patent infringement case against Mylan over the same drug. It is unclear whether Mylan will now also launch its own generic.