Physician's First Watch: Archives

Guidelines for Care of Children in Emergency Departments

"Guidelines for Care of Children in the Emergency Department" is available from Pediatrics.

The guidelines are a joint policy statement from the American Academy of Pediatrics, the American College of Emergency Physicians, and the Emergency Nurses Association. They update a series issued in 2001 and are, at least in part, a response to a 2006 Institute of Medicine report that was critical of the status of pediatric emergency care in the U.S.

The document offers guidelines on essential equipment, personnel, and quality-assurance measures in the care of children by emergency departments that are continuously staffed.

LINK(S):

Pediatrics article (Free PDF)

Published in Physician's First Watch September 29, 2009

FDA Approves New Psoriasis Drug

The FDA has approved a monoclonal antibody — ustekinumab (Stelara) — for the treatment of moderate-to-severe psoriasis.

Approval followed three safety and efficacy studies comprising some 2300 patients.

Ustekinumab is associated with increased risk for infection, the FDA says. It may also pose a heightened risk for cancer.

LINK(S):

FDA news release (Free)

Published in Physician's First Watch September 28, 2009

Smoking, Oral Contraceptive Use Linked to Increased Cardiovascular Risks in Women with Antiphospholipid Syndrome

In young women, the antiphospholipid syndrome is associated with increased risks for MI and ischemic stroke — and smoking and oral contraceptive use substantially accentuate these risks — according to a case-control study in the Lancet Neurology.

Among nearly 400 women aged 18 to 49 with MI or stroke and 630 age-matched controls, presence of lupus anticoagulant (an antiphospholipid antibody) was associated with an odds ratio of about 5 for MI and 43 for ischemic stroke. Smoking increased these odds to 34 and 87, respectively; oral contraceptive use increased the odds to 22 and 201, respectively. Another antiphospholipid antibody, anti-β2-glycoprotein I, was associated with ischemic stroke, but not MI.

Commentators discuss several study limitations but conclude that "young women with [antiphospholipid antibodies] should be informed about the serious risks of cigarette smoking and use of oral contraceptives."

[Editor's note: This study has been released from embargo but has not yet been posted. Our link is to the Lancet Neurology's online-first page, where the article will appear shortly.]

LINK(S):

Lancet Neurology online-first page (Free)

Published in Physician's First Watch September 28, 2009

Another Diabetes Drug Linked to Acute Pancreatitis

The prescribing information for the type 2 diabetes drug sitagliptin (marketed alone as Januvia, and combined with metformin as Janumet) must be revised to note the incidence of acute pancreatitis in some patients using the drug, the FDA announced on Friday.

Some 88 cases have been reported since sitagliptin was approved in 2006; two cases were necrotizing or hemorrhagic pancreatitis. Overall, 20% occurred within a month of drug initiation, and about half resolved after drug discontinuation.

The FDA advises healthcare providers to monitor patients on sitagliptin for signs of pancreatitis (e.g., abdominal pain, nausea, vomiting), and to discontinue the drug if pancreatitis is suspected. Patients should also be educated about these symptoms.

It is not known whether sitagliptin users with histories of pancreatitis are at increased risk for the condition, the FDA says.

LINK(S):

FDA alert (Free)

FDA information for healthcare professionals (Free)

Journal Watch General Medicine 2007 summary on sitagliptin studies (Your Journal Watch registration required)

Physician's First Watch coverage of Byetta and pancreatitis (Free)

Published in Physician's First Watch September 28, 2009

Surgery Modestly Better Than Nonsurgical Treatments for Carpal Tunnel Syndrome

In patients with mild-to-moderate carpal tunnel syndrome who've tried splinting without success, surgery produces greater functional and symptomatic improvements than nonsurgical treatment, a Lancet study shows.

Among more than 100 patients randomized to surgery or nonsurgical therapy (including splinting and hand exercises), substantial crossover occurred. Intent-to-treat analyses showed 67% of patients had functional improvement of 30% or more at 1 year with surgery, compared to 46% with nonsurgical treatment. In as-treated analyses, improvements were 73% and 33%, respectively. Surgery was not associated with any "clinically important" adverse events.

The authors write that differences between the groups, while statistically significant, were "of moderate clinical relevance."

Commentators conclude that although nonsurgical treatments have their place, especially for those with short histories of carpal tunnel, "patients ... who do not have satisfactory improvement with non-surgical treatment should be offered surgery."

LINK(S):

Lancet article (Free abstract; full text requires subscription)

Lancet comment (Subscription required)

Published in Physician's First Watch September 28, 2009

Maternal Use of Sertaline, Citalopram Linked to Septal Heart Defects in Offspring

Women who use the antidepressants sertraline (Zoloft) or citalopram (Celexa) early in pregnancy face increased risk for septal heart defects in their offspring, BMJ reports online.

Researchers examined data on more than 490,000 infants born in Denmark between 1996 and 2003. They found that women who filled prescriptions for sertraline and citalopram (but not other SSRIs) during their first trimester were significantly more likely to have children with septal heart defects (but not other malformations) than those who didn't use SSRIs (odds ratios: 3.2 and 2.5, respectively).

The authors and an editorialist (both with ties to SSRI manufacturers) note that the absolute risks for septal heart defects were low: 0.9% in children exposed to at least one SSRI and 2.1% in those exposed to more than one. The editorialist concludes: "Clinicians and patients need to balance the small risks associated with SSRIs against those associated with undertreatment or no treatment."

LINK(S):

BMJ article (Free)

BMJ editorial (Subscription required)

Recent American Psychiatic Association and American College of Obstetricians and Gynecologists report on management of maternal depression (Free abstract; full text requires subscription)

Previous Physicians First Watch coverage of SSRIs and congenital defects (Free)

Published in Physician's First Watch September 25, 2009

Prostate-Specific Antigen Doesn't Measure Up as a Screening Test

Despite its value as a prognostic marker, prostate-specific antigen does not meet criteria for use as a screening test for prostate cancer, according to a BMJ study published online.

Using a large Swedish cohort linked to a national cancer registry, researchers compared the initial PSA values of those who developed prostate cancer over roughly 7 years post-screening with other matched men who did not develop cancer. The overlap in PSA values between the two groups frustrated researchers' efforts to find a cut-off value that had a high specificity as well as a sensitivity above 50%. (However, they note that a PSA value below 1 ng/mL "virtually ruled out" a diagnosis during the follow-up period.)

An accompanying review argues that "data on [PSA testing's] costs and benefits remain insufficient to support population based screening."

LINK(S):

BMJ article (Free)

BMJ editorial (Subscription required)

BMJ analysis (Subscription required)

Published in Physician's First Watch September 25, 2009

ACIP Recommends Revaccinating High-Risk Patients for Meningococcal Disease

The Advisory Committee on Immunization Practices (ACIP) recommends that people with prolonged increased risk for meningococcal disease should be revaccinated with the quadrivalent meningococcal conjugate vaccine (MCV4, Menactra), according to an article in MMWR.

The following groups qualify as having a prolonged elevated risk:

• patients with increased susceptibility, such as persistent complement component deficiencies;
  
• those with anatomic or functional asplenia;
  
• those with prolonged exposure (e.g., patients traveling to or living in nations where the disease is epidemic or hyperendemic).
  

Such patients who were vaccinated at ages 7 and up should receive the MCV4 vaccine 5 years after their previous vaccination, while those vaccinated between ages 2 and 6 years should be revaccinated 3 years after their last vaccination. Patients who remain at high risk should be revaccinated every 5 years thereafter.

LINK(S):

MMWR article (Free)

Published in Physician's First Watch September 25, 2009

Certain Lots of 21 Tylenol Formulations for Children and Infants Recalled

Certain lots of 21 children's and infants' Tylenol formulations are being recalled because internal testing found Burkholderia cepacia in an inactive ingredient, McNeil Consumer Healthcare said in a letter to healthcare professionals.

The contaminated ingredient, which the letter does not identify, was never used in any finished product, the company says. However, as a precaution, it has recalled all products using any of the ingredient manufactured at the same time as the contaminated ingredient — between April and June of 2008.

The manufacturer's press release includes a list of affected lots and products.

LINK(S):

Manufacturer letter to healthcare professionals (Free PDF)

Published in Physician's First Watch September 25, 2009

HIV Vaccine Shows Unexpected, if Limited, Success

A combination of two previously unsuccessful vaccines was about 30% effective in protecting recipients from HIV in a large trial conducted in Thailand, the New York Times reports.

The results were announced overnight by Dr. Anthony S. Fauci, the head of the U.S. National Institute of Allergy and Infectious Diseases, which cosponsored the trial.

According to the Times report, some 16,000 volunteers received either the vaccine or placebo and were followed for 3 years. By the end of the trial, 74 of those receiving placebo became infected with HIV, while 51 of those receiving vaccine did.

Dr. Fauci, according to the Times, commented: "For more than 20 years now, vaccine trials have essentially been failures. Now it's like we were groping down an unlit path, and a door has been opened. We can start asking some very important questions."

LINK(S):

New York Times story (Free)

Published in Physician's First Watch September 24, 2009