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Weekly Drug News Round-Up: March 30, 2016

Defitelio Approved for Life-Threatening Condition After Stem Cell Transplant

Common side effects included low blood pressure, diarrhea, vomiting, nausea, and nosebleeds Read More...

The FDA has approved Defitelio (defibrotide sodium) by Jazz Pharmaceuticals for the treatment of adults and children with hepatic veno-occlusive disease (VOD) with kidney or lung dysfunction following hematopoietic stem-cell transplantation (HSCT). Defibrotide is a deoxyribonucleic acid derivative anticoagulant. In studies, patients with a diagnosis of hepatic VOD with multi-organ dysfunction after transplantation received defibrotide sodium until resolution of VOD. The Day +100 survival rates for Study 1, Study 2 and Study 3 were 38%, 44%, and 45% respectively. In comparison, historical controls looking at Day +100 survival rates for patients who received supportive care or interventions other than defibrotide sodium ranged from 21% to 31%. 

FDA Guidance Informs Generic Industry on Abuse-Deterrent Painkillers

Goal is to ensure generic abuse-deterrent products are as effective as their brand counterparts Read More...

In the continuing war on opioid abuse in this country, the U.S. Food and Drug Administration (FDA) issued a draft guidance last week to inform general principles for manufacturers of generic abuse-deterrent opioid painkillers. As noted in the guidance, “FDA considers development of these products a high public health priority.” Abuse-deterrent painkillers contain properties that make it harder to crush and snort, dissolve and inject, or smoke the ingredients. Currently approved abuse-deterrent forms - such as Oxycontin (oxycodone), Embeda (morphine/naltrexone), or Zohydro ER (hydrocodone) - are extended-release, brand name products with higher cost. Generic development of abuse-deterrent forms would allow safer painkillers at a more affordable cost.

Tetanus Boosters Every Decade or Not? Study

Researchers state revising the schedule could save the health care system hundreds of millions Read More...

Is it about time to get your tetanus shot booster? Typically, this has been recommended every 10 years, but a new study in Clinical Infectious Diseases suggests adults can get the tetanus and diphtheria vaccine boosters every 30 years instead. Investigators looked at how well protected over 500 adults were after completing the standard five-dose shot series given in childhood. They found adults remain protected against tetanus and diphtheria for at least 30 years without the need for further booster shots. Notably, other health care experts, including the WHO and the UK healthcare system, do not recommend boosters every 10 years.

Non-Adherence to Heart Meds Can Boost Stroke Risk

Drug cost, lack of drug knowledge and multiple meds can contribute to patient non-adherence Read More...

High blood pressure and high cholesterol are two potentially deadly conditions, but medications can effectively control these disorders. But what if you only take one of your medications, skipping the other? A new study published in Journal of the American College of Cardiology showed that if patients kept taking their blood pressure medication but dropped their statin, their risk of stroke death increased by 82 percent. On the other hand, their risk of stroke was increased by 30% if they took their statin but stopped their blood pressure med. And what if both meds are skipped? The risk of suffering a fatal stroke is magnified by seven times.

FDA Advisory Panel Votes In Favor of Nuplazid

Roughly 2 million people worldwide are estimated to suffer from Parkinson’s disease psychosis Read More…

During a Psychopharmacologic Drugs Advisory Committee meeting this week, members voted in favor, 12 to 2, that the benefits of Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease outweigh the risks of treatment. Nuplazid, from Acadia Pharmaceuticals, is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors. The drug was granted Priority Review status and was designated a Breakthrough Therapy. If approved by the FDA, Nuplazid would be the first drug indicated to treat psychosis associated with Parkinson’s disease, a significant unmet need. Final FDA decision is expected by May 1, 2016.

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