Physician's First Watch: Archives

ACP Issues Guidelines on Hormonal Testing and Pharmacologic Management of Erectile Dysfunction

Men who seek treatment for erectile dysfunction should be started on phosphodiesterase-5 (PDE-5) inhibitors, according to new clinical practice guidelines from the American College of Physicians.

The guidelines, based on a review of randomized controlled trials and observational studies, cite high-quality evidence showing "significant and clinically relevant improvements" in sexual intercourse and erectile function in men treated with PDE-5 inhibitors. (The drugs should not be used in men with contraindications to such treatment, such as nitrate therapy.)

Among the other conclusions, published online in Annals of Internal Medicine:

• Choice of PDE-5 inhibitor should depend on patient preference and take into account facility of use, cost, and side effects (low-quality evidence, weak recommendation).
  
• Evidence was insufficient to recommend for or against routine hormonal testing or hormonal therapy in the management of ED.
  

LINK(S):

ACP guidance statement in Annals of Internal Medicine (Free)

ACP meta-analysis in Annals of Internal Medicine (Free)

Published in Physician's First Watch October 20, 2009

Adding HPV Vaccination to U.S. Cervical Screening Isn't Cost-Effective After Age 30

HPV vaccine use in U.S. women over 30 who undergo screening for cervical cancer would not be cost-effective, concludes a study in Annals of Internal Medicine.

Using epidemiologic and cancer-registry data in simulation models, researchers examined the benefits of vaccination in women over 30 who undergo annual or biennial screening with either cytology plus HPV DNA testing for triage of equivocal results, or combined cytology and DNA testing. They found that, for example, when vaccination was added to biennial screening and DNA testing at age 35, the added life span gained was less than 48 hours, and the cost per quality-adjusted life year (QALY) gained was over $100,000. After age 35, the costs per QALY generally ranged from $200,000 to $400,000 with vaccination.

The authors conclude that, rather than vaccinating women over 30, "more health can be gained by investing in alternative interventions, such as screening previously unscreened women."

LINK(S):

Annals of Internal Medicine article (Free abstract; full text requires subscription)

Published in Physician's First Watch October 20, 2009

FDA Warns of Sparks, Fires with Medical Device Power Cords

Medical device users should closely monitor the "wear and tear" of their electrical cords, following over a hundred reports of problems with a specific cord type, according to the FDA.

Hospira and Abbott Nutrition have notified the FDA of 122 cases of sparking, charring, and fires associated with AC power cords made by Electri-cord Manufacturing Company. The cords are readily identifiable with a black plastic bridge connecting the terminal prongs. The prongs can crack and fail at or inside the plug.

These power cords have also been supplied to other device manufacturers.

LINK(S):

FDA alert (Free)

MedWatch online reporting form (Free)

Published in Physician's First Watch October 20, 2009

Seasonal Flu Vaccine Fluarix Approved for Children

The FDA has approved Fluarix, an inactivated seasonal influenza vaccine, for use in children ages 3 to 17 years. The vaccine was previously approved for adults.

In a study of more than 3000 children, those vaccinated with Fluarix had similar levels of antibodies to those given Fluzone, an approved pediatric flu vaccine. Side effects were similar to those seen with other flu vaccines.

LINK(S):

FDA news release (Free)

Published in Physician's First Watch October 20, 2009

FDA Expands Boxed Warning on Iron Dextran Injections

The boxed warning on risk for anaphylactic reactions with Dexferrum (iron dextran) injections has been updated with guidance on giving a test dose before therapeutic dosing and watching for anaphylactic reactions during administration, the FDA has announced.

Fatal reactions have occurred after the test dose and with the therapeutic dose even after testing was tolerated, according to the manufacturer. Patients with drug allergies may be at increased risk.

The manufacturer recommends that resuscitation equipment and trained personnel be "readily available" when Dexferrum is given.

LINK(S):

FDA alert (Free)

Updated Dexferrum label (Free PDF)

Manufacturer letter to healthcare professionals (Free PDF)

Published in Physician's First Watch October 19, 2009

Thiopurines Linked to Increased Lymphoma Risk in Patients with Inflammatory Bowel Disorders

Patients using thiopurines to manage inflammatory bowel disease face increased risk for lymphoproliferative disorders, according to an observational study published online in Lancet.

Researchers in France followed some 19,500 patients with inflammatory bowel disease (Crohn disease, ulcerative colitis, or unclassified disease) for about 3 years.

During follow-up, lymphoproliferative disorders were diagnosed in 23 patients — 15 thiopurine users, 2 former users, and 6 patients who'd never used thiopurines. In adjusted analyses, lymphoma risk was five times higher among current users than among those who'd never received the drugs.

LINK(S):

Lancet article (Free abstract; full text requires subscription)

Lancet comment (Subscription required)

Published in Physician's First Watch October 19, 2009

Gardasil Approved for Use in Males, New HPV Vaccine Approved for Females

The quadrivalent human papillomavirus vaccine (Gardasil) has been approved to help prevent genital warts in males aged 9 through 26, the FDA announced on Friday. As in girls and young women, the vaccine will be given as three injections over a 6-month period.

The agency also approved a bivalent HPV vaccine (Cervarix) for use in females aged 10 through 25, according to the manufacturer. The vaccine, which protects against oncogenic HPV types 16 and 18, is expected to be available in the U.S. by the end of 2009.

LINK(S):

FDA news release on Gardasil (Free)

Manufacturer news release on Cervarix (Free)

Physician's First Watch coverage of FDA advisory panel recommendations on both approvals (Free)

Published in Physician's First Watch October 19, 2009

Prophylactic Acetaminophen Reduces Immunogenicity of Childhood Vaccines

Children given acetaminophen with vaccinations have lower rates of fever in response, but the vaccinations produce a lower immunogenicity, reports a Lancet study.

Researchers, including some from the sponsoring vaccine manufacturer, followed over 400 infants receiving primary and booster immunizations. Half received acetaminophen via suppository in three doses over the first 24 hours after vaccination, and half received no prophylaxis.

The percentage of children with a temperature of 38 degrees C or higher was significantly lower in the acetaminophen group by some 40% to 50% both at primary and booster immunizations. However, vaccine immunogenicity was lower in the acetaminophen group — significantly so for some antigens, e.g., all 10 pneumococcal serotypes after the primary immunization. The authors hypothesize that the effect could result from acetaminophen's preventing inflammation.

Over 95% of all children had seroprotective antibody levels, but researchers argue that antipyretics "should ... no longer be routinely recommended" with vaccination. Editorialists agree, calling the case "compelling."

LINK(S):

Lancet article (Free abstract; full text requires subscription)

Lancet comment (Subscription required)

Published in Physician's First Watch October 16, 2009

Talking Points: Pediatric Allergies by Race

A chart in this week's MMWR shows the racial breakdown of various allergies before age 18, based on data from the 2008 National Health Interview Survey:

• food allergies: roughly 5% of all children;
  
• skin allergies: 15% of blacks, 10% of whites;
  
• respiratory allergies: 12% of whites, 8% of Asians;
  
• hay fever: 10% of whites, 8% of blacks, 5% of Asians.
  

LINK(S):

MMWR article (Free)

Published in Physician's First Watch October 16, 2009

Nursing Home Residents See Marked Declines in Functional Status After Starting Dialysis

Nursing home residents with end-stage renal disease experience "substantial and sustained" declines in functional status after starting dialysis, according to a New England Journal of Medicine study.

Using national databases, U.S. researchers identified some 3700 nursing home residents (mean age, 73) who began dialysis between 1998 and 2000. The patients underwent functional status assessments (measuring 7 activities of daily living) before initiating dialysis and every 3 months afterward for 12 months.

At 3 months, 61% of the patients had reduced functional status or had died, and by 12 months, this proportion rose to 87%.

The authors point out that because there was no control group, they could not conclude that dialysis caused the observed functional decline. Meanwhile, editorialists write: "Prior to the initiation of dialysis, elderly patients must be informed about its modest benefit in their age group and the possibility of conservative therapy that does not involve dialysis."

LINK(S):

NEJM article (Free abstract; full text requires subscription)

NEJM editorial (Subscription required)

Journal Watch General Medicine summary (Your Journal Watch subscription required)

Published in Physician's First Watch October 15, 2009