FDA hears concerns on new narcotic pain pill rules

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Feb 11 2013

Survivors of those who died from opioid overdoses urge changes in the drugs' labels, but some patients express concerns that they might have trouble getting the drugs.

The Wall Street Journal: FDA Convenes Hearing On Pain-Pill Labels
Relatives of overdose victims pleaded with federal drug regulators Thursday to change the label on a widely used class of narcotic painkillers in a charged day of testimony in Washington. Some pain patients, meanwhile, warned that any action could limit their access to the drugs. The Food and Drug Administration convened the two-day public hearing on so-called opioid painkillers, amid concern that they are fueling an epidemic of addiction and overdose deaths (Catan, 2/7).

Meanwhile, The Washington Post examines the compounding pharmacies that were at the center of a recent outbreak of meningitis.

The Washington Post: Compounding Pharmacies Have Been Linked To Deaths, Illnesses And Safety Failures For Years
Shoddy practices and unsanitary conditions at three large-scale specialty pharmacies have been tied to deaths and illnesses over the past decade, revealing that the serious safety lapses at a Massachusetts pharmacy linked to last fall's deadly meningitis outbreak were not an isolated occurrence, records and interviews show (Kindy, Sun and Crites, 2/7).

Medpage Today: State Shutters 10 Compounding Pharmacies
Officials in Massachusetts ordered 10 pharmacies to halt sterile compounding activities after surprise inspections found major violations of quality standards, the state's public health department said. … Complete or partial cease-and-desist letters were sent in November and December to a total of 11 Massachusetts pharmacies after the surprise inspections, according to a statement released this week by the state's Department of Public Health. In addition to ordering 10 of the pharmacies to stop all sterile compounding, officials told another to halt compounding of one particular drug, sildenafil citrate (Gever, 2/7).

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.