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Weekly Drug News Round Up - July 11, 2012

FDA Approves Educational Opioid REMS Program

Prescribers, patients are focus of safety education on potent narcotic pain-relievers Read More...

Misuse and abuse of potent narcotic pain relievers, such as Oxycontin, are a national public health crisis. The U.S. Food and Drug Administration (FDA) has approved a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioids used for long-term treatment of moderate to severe pain. The REMS will provide new safety information for prescribers and patients according to a FDA-developed blueprint. The programs will most likely be funded by educational grants given by the drug manufacturers to independent continuing educational companies. The voluntary programs will be built to educate prescribers and patients alike on the safe use of opioids, how to recognize abuse, safe storage and disposal, and patient counseling information among other topics.

Medical Groups Agree Hormone Replacement Therapy Can Be Useful

In the last decade hormone replacement therapy has been abandoned, but may not need to be Read More...

Fifteen leading medical groups, including the American Academy of Family Physicians, agree that hormone replacement therapy (HRT), for example Premarin (conjugated estrogen) or Prempro (conjugated estrogen/medroxyprogesterone), can be useful and safe in recently menopausal women. Fear of HRT was initiated in 2002 after the Women’s Health Initiative study suggested HRT was unsafe due to increased risks for breast cancer and heart disease. However, experts now say that short-term HRT can be an acceptable choice for relatively young women (up to age 59 or within 10 years of menopause) on a case-by-case basis. Estrogen and progesterone should still be used in combination for women with an intact uterus to prevent uterine cancer. Additional recommendations are proposed.

H1N1 Vaccine Safe for Expectant Mothers and Their Babies: Study

Adverse events in newborns not shown to differ between pregnant women who received vaccine and those who did not Read More...

A Danish study has shown that the H1N1 vaccine is safe for use in pregnant women. The vaccine was hastily developed when the H1N1 influenza pandemic hit in the summer of 2009, but was given to pregnant women who are considered a high risk population. The study published in the Journal of the American Medical Association evaluated over 53,000 women, 13 percent of whom received the H1N1 vaccine. No differences in birth weights or major birth defects within the first year were detected among babies whose mothers received the H1N1 vaccine during pregnancy. An additional study has found the risk of Guillain-Barre syndrome is rare with the H1N1 vaccine, with two cases occurring per one million doses of administered vaccine.

Generic Version of Lyrica FDA-Approved

Lupin Pharmaceuticals receives FDA approval for generic equivalent for Lyrica capsules Read More...

The U.S. Food and Drug Administration (FDA) has given the approval for Lupin Pharmaceuticals generic version of Lyrica, known as pregabalin. Lyrica is a top selling treatment for different types of neurological conditions, including pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, as an adjunct to therapy for patients with partial onset seizures and for fibromyalgia. Lyrica was also the 24th best selling product worldwide in 2011, with over $3.8 billion in sales, according to EvaluatePharma. Generic pregabalin will be available in various strengths, ranging from 25 mg up to 300 mg capsules.

Mental Health Woes from Aging Boomers May Swamp Healthcare System

The senior population exceeds 72 million by 2030; U.S. healthcare unprepared for geriatric mental health issues Read More...

A new report mandated by Congress and issued by the Institute of Medicine entitled The Mental Health and Substance Use Workforce for Older Adults: In Whose Hands? suggests mental health woes from aging baby boomers could overtake an unprepared U.S. healthcare system. Up to 8 million older Americans, or 20 percent of the current senior population, suffer from depression, illicit drug or alcohol abuse, or dementia risk. To add to the problem, the current number of specialized healthcare workers in geriatrics with mental health or substance abuse expertise is insufficient. Suggestions from the report include additional training for healthcare providers, supplemental Medicare/Medicaid reimbursement, and federal government coordination of efforts.