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All Posts in Category: FDA

FDA Strengthens Warning on Combining Benzos and Opioids

The FDA expanded its warnings against using opioids and benzodiazepines concomitantly. This action is based on new information on three specific opioids—buprenorphine, buprenorphine-naloxone and methadone, which are typically prescribed for the treatment of opioid use disorder—and the risk for respiratory depression when these drugs are used with benzodiazepines or other central nervous system (CNS) depressants.

According to the FDA alert, “the combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care professionals can reduce these risks.”

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Opioid commission unveils new partnerships, drug supply limits to stop epidemic

New Jersey Governor Chris Christie held the third formal meeting of President Trump’s ongoing Commission on Combatting Drug Addiction and Opioid Crisis, where officials in the pharmaceutical industry and government detailed new partnerships and efforts in the hopes of limiting the use of opioid prescriptions for combatting pain and recommending new treatments for pain management without the use of addictive substances.

National Institutes of Health Director Dr. Francis Collins advised the commission that the agency is looking to build partnerships with researchers across academia, government, prescribers and patients to “cut in half the time needed to make available prescriptions that are non-addictive.”

He said areas like developing “potent but non-addictive drugs” for pain relief and offering new avenues for treatment would become a top priority for the partnership.

Source: CBS News
Read More: https://www.cbsnews.com/news/opioid-commission-unveils-new-partnerships-drug-supply-limits-to-stop-epidemic/

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FDA wants opioid painkiller pulled off market

(CNN)The US Food and Drug Administration said Thursday that drugmaker Endo Pharmaceuticals must remove its powerful opioid painkiller Opana ER from the market. The agency says this the first time it has asked that an opioid pain medication be pulled due to “the public health consequences of abuse.”

“We are facing an opioid epidemic — a public health crisis — and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
Source: CNN
Read Full Story Here: http://www.cnn.com/2017/06/08/health/fda-opioid-opana-er-bn/index.html
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FDA Joint Committee Votes Opana ER Risks Outweigh Benefits

The benefits of oxymorphone hydrochloride extended-release tablets (Opana ER, Endo Pharmaceuticals) do not outweigh its risks to public health, according to a joint FDA advisory committee.

Members of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a two-day meeting and voted 18-8—with one abstention—that the drug’s risk–benefit ratio has changed for the worst. Most of the panelists agreed that the drug should be removed from the market due to its high potential for IV abuse and misuse: Several outbreaks of HIV, hepatitis C and vascular issues were related to IV abuse of the drug.

“This formulation of oxymorphone has unintended consequences that deserve its removal from market,” said Charles Emala, MD, professor of anesthesiology at Columbia University in New York City, one of the panelists who voted against the drug, MedPage Today reported.

Endo presented efficacy data during the meeting, including postmarketing data on abuse and misuse compiled from the National Addictions Vigilance Intervention and Prevention Program and the RADARS System Drug Diversion Program. The company reported that the increases in oxymorphone-related death and overdose rates were associated with the introduction of the abuse-deterrent formulation of oxycodone (OxyContin ADF; Purdue Pharma) in August 2010, and decreased after the introduction of the oxymorphone reformulation.

Many panelists acknowledged a lack of data, but believed there was enough to conclude that oxymorphone carried increased risks related to injection abuse.

The drug has had a difficult regulatory history with the FDA. It earned a reputation for severe abuse when it originally came to the market in 1959, and was removed in the 1970s.

Source: PainMedicineNews.com
Full Article: FDA_Opana

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