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IPA News

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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#PainStopsHere Facebook Challenge

Integrated Pain Associates #PainStopsHere Facebook Challenge

Starting June 1, Integrated Pain Associates has a new challenge for you. We want to see how treatment at Integrated Pain Associates has improved your quality of life and helped you get back to enjoying your favorite activities. We call it the #PainStopsHere Facebook Challenge and all you’ve got to do is put on a (free!) shirt, snap a picture of yourself showing off your improved quality of life, and let the world know on Facebook.

Here’s how it works!

  1. Jump onto Facebook or Yelp and leave a review of Integrated Pain Associates while you’re at one of our two clinics in Killeen or Waco.
  2. Show the receptionist the new review on your mobile device and you’ll get a free #PainStopsHere t-shirt on the spot.
  3. Snap a picture of yourself showing-off your improved mobility and quality of life while wearing your #PainStopsHere t-shirt.
    • This can be big things like playing golf or working out at the gym.
    • Or little thing like opening a jar of pickles, sewing or cooking with ease.
  4. Post your Photo to Facebook, tag @IPACLINIC and include the hashtag #PainStopsHere.

By posting your photo, you’ll be entered into our monthly contest, where we’ll be giving away all kinds of prizes that will help you go on pain free adventures or enjoy some well earned relaxation. Follow us on Facebook to see each month’s prize!

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Guidelines for Prescribing Opioids

CDC’s Guideline for Prescribing Opioids for Chronic Pain is intended to improve communication between providers and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder and overdose. The Guideline is not intended for patients who are in active cancer treatment, palliative care, or end-of-life care.

For the Full Article, see the below link.
Guidelines for Opioids – CDC

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We regret to inform you that Integrated Pain Associates will no longer be providing services in Brownwood as of June 15, 2017.  We would love to continue to care for you at one of our other facilities, and we will be happy to make you an appointment at the location of your choice.

Unless otherwise directed, Integrated Pain Associates will forward your medical records back to your primary care provider.  If you would like a copy of your medical records, please obtain a records release from the receptionist.

Alternate Integrated Pain Associates locations

3800 South W.S. Young Dr Suite 201
Killeen, Texas 76542

1000 West HWY 6, Suite 130
Waco, Texas 76712

Thank you for your understanding.

-Integrated Pain Associates

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We regret to inform you that Dr. Brian Goentzel will be relocating to Kansas.  You may continue to seek care from Dr. Goentzel however, we would love to continue to care for you here at Integrated Pain Associates, and we will be happy to make you an appointment with one of our other providers.

Unless otherwise directed, Integrated Pain Associates will continue to remain the medical record custodian of your records and will continue to treat you here.  If you would like a copy of your medical records, please obtain a records release from the receptionist.

Dr. Goentzel’s new location:
Via Christi Pain Management Clinic
1947 Founders Circle
Wichita, KS 67206

Thank you for your understanding.

-Integrated Pain Associates

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IPA Welcomes Dr. Kristian Delgado

Dr. Delgado is a Texas native that received his undergraduate degree and attended graduate school at the University of Texas at San Antonio. He is well versed in both acute and chronic pain and has been treating pain both as a civilian physician and a United States Army Officer for a decade. Dr Delgado is very passionate about the Texas community and the care of Veterans and their families.

He joined Integrated Pain Associates to practice with a multidisciplinary, collaborative team sharing the goal of reducing the patients’ pain therefore improving their quality of life.

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DEA’s National Drug Take-Back Day Set for Saturday, April 29

The Drug Enforcement Administration’s (DEA’s) National Prescription Drug Take-Back Day—set for this Saturday, April 29, 2017, from 10 a.m. to 2 p.m. local time—will once again see communities across the country joining with law enforcement to help remove unwanted and potentially dangerous medications from medicine cabinets across the United States.

People can call the DEA’s Registration Call Center at (800) 882-9539 or click here for collection sites in their area. The website will be continuously updated with new take-back locations.

Source: Pain Medicine News
Read Full Article

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FDA nominee says nation’s opioid crisis is as serious as Ebola, Zika threats

Scott Gottlieb, the physician and entrepreneur who is President Trump’s nominee to head the Food and Drug Administration, told senators Wednesday that the nation’s opioid crisis is a “public health emergency on the order of Ebola and Zika” and requires dramatic action by the agency and the rest of government.

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