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Drugs Article Archives

August 2014

Dompé Earns Orphan Drug

An Italian-based pharmaceutical company with subsidiaries in New York has been granted orphan drug status for a new drug to treat neurotrophic keratitis, a rare degenerative corneal disease that impacts less than 1 in 5,000 people worldwide.

comments 0 comments - Posted Aug 20, 2014

FDA Lifts Restrictions on Patient Access to Avandia

The type 2-diabetes drug Avandia will again be available through retail pharmacies after a May ruling by the U.S. Food and Drug Administration.

The drug - a rosiglitazone-based medicine that controls blood glucose by increasing the body’s sensitivity to insulin, so cells and muscles are able to use more for energy, reducing levels in the blood - was off the market in Europe and restricted in the United States for several years due to studies showing the drug raised the risk of heart disease. The FDA in 2013 reversed its earlier opinion and lifted restrictions on the drug, opening the doors for Avandia’s return to market.

Initially released in 1999, Avandia had been one of Glaxo's top-selling medicines, with sales of $3.2 billion in 2006. Sales tanked in 2010 after a review of clinical trials showed an increased risk of heart attack related to the drug – those taking the drug in the United States dropped from 120,000 to 3,000 – but last year, new trials showed no elevated risk of heart attack or death in patients being treated with Avandia compared to other diabetes drugs, causing the FDA to reverse its opinion.

“GSK welcomes the decision of the FDA and appreciates the agency’s robust review of the science about Avandia,” Glaxo said in a statement last year. “GSK maintains its view that Avandia is a safe and effective treatment for Type 2 diabetes when used appropriately.”

While the drug had previously been available only through specialty pharmacies and the patients already taking the drug or whose symptoms were not adequately controlled by other drugs, the new FDA ruling allows all patient's access to Avandia, Avandamet and Avandaryl. All of these medications contain rosiglitazone.

“Our actions reflect the most current scientific knowledge about the risks and benefits of this drug,” Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement last year. “Given these new results, our level of concern is considerably reduced; thus, we require the removal of certain prescribing restrictions.”

While the drug’s manufacturer, GlaxoSmithKline, has a marketing hurdle to overcome given the bad press the drug has received over the last few years, the British drug maker has no plans to promote Avandia in the United States, in part because its U.S. patent protection lapsed in 2011.
The drug will be available by prescription.

To assist in the transition, a toll-free telephone number has been established for patients, healthcare professionals and pharmacies - 1-800-282-6342 – which will be staffed from 8;30 a.m. to 5 p.m. Monday through Friday Eastern Time.

comments 0 comments - Posted Aug 7, 2014

November 2012

Penny Hildreth: Finally Facing Diabetes

It was more than two decades ago, and Penny Hildreth was already feeling overwhelmed by life when she learned that she had type 1 diabetes. She was pregnant with her second child and worried about the baby’s safety after a car accident that had left Hildreth with a broken collarbone, a broken rib, and a punctured spleen. It was the spleen injury that ultimately led to her diagnosis of diabetes, but she was more concerned about the baby, a little girl who was born healthy despite the automobile accident. “I always say that she’s my miracle,” says the 46-year-old Portland resident.

comments 1 comment - Posted Nov 6, 2012

September 2012

Mayo Clinic Says Simple Lifestyle Changes Can Forestall Type 2

The Mayo Clinic Health Letter for August 2012 has published three lifestyle changes that could stave off the progression of prediabetes to full-blown type 2 diabetes. The list isn't new, but its periodic reiteration indicates that healthcare researchers and providers have settled on a simple prescription for staying diabetes-free.

comments 1 comment - Posted Sep 4, 2012

July 2012

Diabetes: Hospital Bills Cost U.S. $83 Billion A Year

Diabetes affects nearly 25 million Americans, and that number is expected to grow substantially every year. It's the fifth leading cause of death in America, more than breast cancer and AIDs combined. And according to a report released last week from the Agency for Healthcare Research and Quality (AHRQ), it's a disease that’s costing Americans $83 billion a year in hospital fees — 23 percent of total hospital spending.

comments 2 comments - Posted Jul 5, 2012

April 2012

Neuropathy Device Maker Files

NeuroMetrix, Inc., a Massachusetts-based medical device company, has filed a 510(k) form with the US Food and Drug Administration for the SENSUSTM, a pain therapy device for people who suffer diabetic neuropathy. A 510(k) is a "premarket notification" of a company's intent to market a medical product. The FDA then tests the product and provides feedback to the manufacturer. Once the FDA clears the product, its maker can introduce it to the US market.

comments 1 comment - Posted Apr 24, 2012

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