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New drug approved for tuberculosis

1/3/2013

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FDA approves 1st new tuberculosis drug in 40 years


Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis


WASHINGTON — The Food and Drug Administration on Monday approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.

The agency approved J&J's pill, Sirturo, for use with older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications. However, the agency cautioned that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by doctors.

Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis. The disease is rare in the U.S., but kills about 1.4 million people a year worldwide. Of those, about 150,000 succumb to the increasingly common drug-resistant forms of the disease. About 60 percent of all cases are concentrated in China, India, Russia and Eastern Europe.

Sirturo, known chemically as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That's a form of the disease that cannot be treated with at least two of the four primary antibiotics used for tuberculosis.

The standard drugs used to fight the disease were developed in the 1950s and 1960s.

"The antibiotics used to treat it have been around for at least 40 years and so the bacterium has become more and more resistant to what we have," said Chrispin Kambili, global medical affairs leader for J&J's Janssen division.

The drug carries a boxed warning indicating that it can interfere with the heart's electrical activity, potentially leading to fatal heart rhythms.

"Sirturo provides much-needed treatment for patients who have don't have other therapeutic options available," said Edward Cox, director of the FDA's antibacterial drugs office. "However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options."

Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.

Despite the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results.

Last week, the consumer advocacy group Public Citizen criticized that approach, noting the drug's outstanding safety issues.

"The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval," the group states. "But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug."

The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo. Both studies were designed to measure how long it takes patients to be free of tuberculosis.

Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with 125 days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.


http://www.ems1.com/medical-clinical/articles/1386541-FDA-approves-1st-new-tuberculosis-drug-in-40-years/

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Paramedics administer expired drugs due to shortages

7/13/2012

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Some paramedics are injecting expired medications, despite a risk they won't work as intended

By Jonathan J. Cooper
Associated Press

SALEM, Ore. — When paramedics ran out of a critical drug used to treat irregular heartbeats, the Bend Fire Department in Central Oregon dug into its stash of expired medications, loaded up the trucks and kept treating patients.

Paramedics reported asking some of those facing medical emergencies: "Is it OK if we use this expired drug?"

Emergency responders in various jurisdictions have reported turning to last resort practices as they struggle to deal with a shortage of drug supplies created by manufacturing delays and industry changes.  Some are injecting expired medications or substituting alternatives. Others are simply going without.


The University of Utah's Drug Information Service reports 275 medications are in short supply. Clinics and hospitals have reported struggles getting chemotherapy drugs to treat cancer and anesthetics used in surgery.

In the past two years, paramedics from different agencies have dealt with shortages of critical first-line drugs like Valium to treat seizures, dextrose 50 to boost the blood sugar of diabetics and magnesium sulfate for eclampsia, an attack of convulsions during pregnancy.  They've run low on painkillers and sedation drugs.

Full story: http://www.ems1.com/ems-products/medical-equipment/articles/1314096-Paramedics-turn-to-expired-drugs-due-to-shortages/
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www.medicaxpress.com
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http://www.wdde.org
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Emergency Drugs Shortage Worsens

4/5/2012

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A national shortage currently exists for many of the commonly used medications in EMS.
What is the cause of this shortage? The federal agencies seem to be blaming each other, support organizations seem to be blaming the manufacturers, and most seem to blame the regulators.
Whoever is to blame for these shortages, everyone is EMS is feeling the effects. Patient safety is at risk because of the non-availability of many medications.

Full Story: http://www.jems.com/article/administration-and-leadership/drug-shortage-crisis-worsens-ems?utm_source=bm23&utm_medium=email&utm_term=Shortage+Worsens&utm_content=alon.smolarski%40gmail.com&utm_campaign=JEMS+eNews+04-05-12

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Promising results for new heart-attack drug cocktail

4/1/2012

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CHICAGO — Paramedics armed with a cheap, three-ingredient injection cocktail were able to reduce heart attack patients' risk of dying by 50 percent, said a US study released on Tuesday.

When the shot was given early to patients with signs of a heart attack, the mixture of glucose, insulin and potassium, or GIK, showed remarkable success in preventing full cardiac arrest — when the heart stops beating — and even death.

And each shot cocktail costs only about $50, according to the research presented at the American College of Cardiology's 61st annual scientific meeting in Chicago.

"When started immediately in the home or on the way to the hospital — even before the diagnosis is completely established — GIK appears to reduce the size of heart attacks and to reduce by half the risk of having a cardiac arrest or dying," said co-principal investigator Harry Selker.

"Because the trial is the first to show GIK is effective when used by paramedics in real-world community settings, it could have important implications for the treatment of heart attacks," added Selker, executive director of the Institute for Clinical Research at Tufts Medical Center.

Full Story: http://www.ems1.com/cardiac-care/articles/1263253-Cardiac-cocktail-delivered-by-medics-may-save-lives/

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Study Measures Effects of Epinephrine on Prehospital Cardiac Arrest

2/25/2012

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A randomized double blind, placebo control trial looked at the effects of adrenaline (epinephrine) in prehospital cardiac arrest.The study measured survival to hospital discharge but also included a secondary analysis of return of spontaneous circulation (ROSC).
During the study period, a total of 534 patients were enrolled with 262 in the placebo group vs. 272 in the control group (adrenaline).
Investigators found those receiving adrenaline had 3.4 times great odds of achieving ROSC, and 2.2 great odds of survival to discharge.

Jacobs I, Finn J, Jelinek G, et al. Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomized double-blind placebo-controlled trial. Resuscitation. 2011;82(9):1138–1143.

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Paramedics sound alarm on drug shortage

2/22/2012

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DALLAS — Paramedics are quickly running out of popular drugs used to treat some of the most common injuries, the Fort Worth ambulance service Medstar warned on Monday. “I have never seen anything like this,” said Medstar medical director Dr. Jeff Beeson. “I would call it a crisis. It started with a few medications and now it’s hundreds of medications.”

The medicines are in short supply nationwide because drug companies are no longer selling them, he said. The list includes many of the drugs doctors and paramedics use every day. Medstar now has only about a two-day supply of Midazolam — or Versed — a sedative used to treat seizures, and a two-week supply of Morphine and Fentanyl, which are used to treat pain, Beeson said.

Other drugs in short supply include the allergy medicines Benadryl and Epinephrine; Zofran, which controls nausea and vomiting; Valium, used to treat acute seizures; and Mannitol, which helps control pressure in head-injury victims.

http://www.ems1.com/pharmacology/articles/1240720-Paramedics-sound-alarm-on-drug-shortage/

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