Physician's First Watch: Archives

FDA Approves Oral Solution for Subarachnoid Hemorrhage

By The Editors

The FDA has approved a nimodipine oral solution (marketed as Nymalize) to treat subarachnoid hemorrhage. The drug was previously only available in gel-capsule form. Regulators say they hope the new oral formulation, which can also be given via nasogastric tube, will reduce medication errors caused by healthcare providers injecting the liquid contents of the nimodipine capsules intravenously.

LINK(S):

FDA news release (Free)

Published in Physician's First Watch May 15, 2013

Featured in Journal Watch: Orlistat Probably Doesn't Cause Acute Liver Injury

By The Journal Watch Editors

Risk for liver injury was similar in the 90 days before and 90 days after patients' first prescriptions for orlistat (Alli) in a study published in BMJ.

LINK(S):

Journal Watch General Medicine summary (Free)

Published in Physician's First Watch May 15, 2013

USPSTF Issues Guidance on Screening for Alcohol Misuse

By Amy Orciari Herman

In a reaffirmation of its 2004 guidelines, the U.S. Preventive Services Task Force has recommended that clinicians screen adults for alcohol misuse and provide brief behavioral counseling interventions to those who screen positive (grade B recommendation). The guidelines appear in the Annals of Internal Medicine.

The task force says that for adolescents, the evidence is insufficient to weigh the benefits of screening and counseling against the harms (grade I).

The USPSTF issued a draft of these guidelines in September 2012.

LINK(S):

Annals of Internal Medicine article (Free)

Background: Physician's First Watch coverage of draft recommendations (Free)

Published in Physician's First Watch May 14, 2013

Exposure to Agent Orange Associated with Increased Risk for High-Grade Prostate Cancers

By Joe Elia

Vietnam-era veterans exposed to the defoliant Agent Orange are twice as likely to have high-grade prostate cancer findings on biopsy as their nonexposed peers, according to a study in Cancer.

Researchers evaluated some 2700 veterans referred for initial prostate biopsy. Roughly 8% had been exposed to Agent Orange; those whose exposure status was unknown were counted as nonexposed.

Overall, exposure conferred a 52% increased risk for detecting prostate cancer on biopsy. The odds ratio for finding a high-grade cancer (i.e., Gleason score of 7 or higher) was 1.74 among exposed men; for Gleason scores of 8 or higher, it was 2.10. Exposure to the defoliant was not associated with an increased risk for low-grade cancers (Gleason score of 6 or lower).

LINK(S):

Cancer article (Free abstract)

Published in Physician's First Watch May 14, 2013

2012 a Record Year for West Nile Virus Deaths in the U.S.

By Kelly Young

Last year set a record for the number of U.S. deaths caused by West Nile virus, the CDC reports. A total of 5674 people contracted the virus, which led to 286 deaths.

Half the cases reported to the CDC were classified as neuroinvasive. The number of infections increased eightfold over 2011. This is the highest number of reported cases since 2003.

The CDC says the increase was likely attributable to higher temperatures affecting mosquito and bird populations, viral replication in host mosquitos, and bird-mosquito interactions in regions disproportionately affected, according to an NBC News report.

LINK(S):

CDC West Nile virus website (Free)

NBC News story (Free)

Background: Physician's First Watch coverage of West Nile virus in 2012 (Free)

Published in Physician's First Watch May 14, 2013

Beetle: It's What's for Dinner

By Kelly Young

Insects could be part of a sustainable, inexpensive, healthy diet for more of the world, concludes a United Nations report on edible insects.

The authors of the Food and Agriculture Organization report say that six-legged creatures could even help battle obesity, given their high nutrient content, Reuters reports. Mealworms, for instance, have amounts of unsaturated omega-3 fatty acids, protein, and vitamins comparable to fish.

One of the challenges for Western societies will be getting over the element of disgust. In places where insect eating — entomophagy — is more acceptable, the report recommends further promoting edible insects to counter the increasing westernization of diets.

LINK(S):

UN report (Free PDF)

Reuters story (Free)

Published in Physician's First Watch May 14, 2013

Featured in Journal Watch: Bureaucracy and Fecal Transplants

By The Editors

Paul Sax offers some observations on the FDA's decision earlier this month to require INDs (investigational new drug applications) for the use of fecal microbiota transplants. Helpfully, he provides a link to the application forms.

Hold the jokes until recess.

LINK(S):

HIV and ID Observations blog (Free)

Published in Physician's First Watch May 14, 2013

FDA: Newer Opana Not as Abuse-Resistant as Believed

By Amy Orciari Herman

The newer version of the painkiller Opana (oxymorphone), approved in 2012 to help minimize abuse, is still susceptible to misuse and might even be more susceptible to abuse by injection than the original version, the FDA said on Friday.

Accordingly, generic versions of the original formulation can still be approved and marketed, Reuters reports.

The FDA's move comes a month after it blocked generic forms of the original OxyContin; the agency said the abuse-deterrent properties of a newer version, coupled with the original's potential for abuse, meant the original's benefits no longer outweighed its risks.

LINK(S):

Reuters story (Free)

Background: Physician's First Watch coverage of FDA blocking generic OxyContin (Free)

Published in Physician's First Watch May 13, 2013

FDA Approves New Combination Drug for COPD

By Kristin J. Kelley

The FDA has approved a new dry powder inhaler (marketed as Breo Ellipta) to increase airflow and reduce exacerbations in patients with chronic obstructive pulmonary disease. The once-daily maintenance therapy combines the inhaled corticosteroid fluticasone furoate with vilanterol, a long-acting β2-adrenergic agonist (LABA).

In a study of 7700 patients with COPD, those treated with the combination drug had improved lung function and reduced exacerbations, compared with those on placebo.

Like other LABA-containing drugs, Breo Ellipta will carry a boxed warning about the increased risk for asthma-related death (it is not approved for asthma). Additionally, the drug is not recommended for patients younger than 18 years or for use as a rescue therapy for acute bronchospasm. Headache, nasopharyngitis, thrush, and upper respiratory tract infection are the most common side effects; the drug also increases the risks for both bone fractures and pneumonia.

LINK(S):

FDA news release (Free)

Published in Physician's First Watch May 13, 2013

Featured in Journal Watch: The 'Oregon Experiment' at 2 Years

By The Journal Watch Editors

A lottery for Medicaid enrollment simulated a randomized trial in the New England Journal of Medicine.

LINK(S):

Journal Watch General Medicine summary (Free)

Published in Physician's First Watch May 13, 2013