New York to Spend Big to Kill Bloodsucking Guests

29 July 2010 (Reuters Health)—In the city that never sleeps there is one increasingly busy nocturnal resident who New York wants to evict—the bedbug.

The city announced plans on Wednesday to spend $500,000 raising awareness of the tiny bloodsucking mites in a bid to kill them off after bedbug complaints grew by 40% in the past 3 years.

“Everyone wants to come to New York, including bedbugs,” said New York City Councilwoman Christine Quinn. “But we have a message for them … drop dead.”

Former United States President Bill Clinton has battled an outbreak at his Harlem office, along with lingerie outlet Victoria's Secret, teen clothing store Hollister, and countless hotels who have lost thousands of dollars in revenue fighting the bedbug.

New York has been hard hit by bedbugs—who like to nestle in furniture and suck the blood of humans and animals—in part because of the high density living and the millions of tourists who visit the city each year, Quinn said.

Last year >33,000 people called the city's bedbug complaint line to ask for help in dealing with the mites.

Bedbugs don't carry disease, but they can be difficult and expensive to get rid of and cause “emotional, psychological, and economic anguish,” said Councilwoman Gale Brewer.

Editor's comment. We think of scabies as a difficult infestation to eliminate, but in fact, bed bugs can give the mites of scabies a run for their money. Whereas the mites of scabies will die without skin contact for a number of days, bedbugs can survive for up to a year without human contact. Once infected, a mattress and its surroundings may be very difficult to purge of bedbugs. (D.K.)

FDA Drug Safety Communication: Eosinophilic Pneumonia Associated with the Use of Cubicin (Daptomycin)

The United States Food and Drug Administration (FDA) is informing patients and health care professionals about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug.

Cubicin was first approved in September 2003 to treat serious skin infections. In 2006, it was approved to treat bloodstream infections.

Eosinophilic pneumonia is a rare, but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing.

Health care professionals should closely monitor patients being treated with Cubicin for eosinophilic pneumonia. Patients receiving Cubicin should immediately contact their health care professional if they develop a new or worsening fever, cough, shortness of breath, or difficulty breathing.

In 2007, pulmonary eosinophilia was added to the Adverse Reactions, Post-Marketing Experience section of the Cubicin product label. Since then, the Agency has reviewed published case reports of Cubicin-associated eosinophilic pneumonia, and conducted a review of post-marketing adverse event reports from the FDA's Adverse Event Reporting System (AERS). FDA's review identified 7 cases of eosinophilic pneumonia between 2004 and 2010 that were most likely associated with Cubicin.

Based on these reviews, FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label.

Of the 7 cases:

• The ages ranged from 60 to 87 years.

• Eosinophilic pneumonia developed 2–4 weeks after initiating Cubicin treatment.

• All 7 cases reported improvement or resolution of symptoms after Cubicin was discontinued. Five of the 7 cases were also treated with systemic corticosteroids.

• Two cases reported recurrence of eosinophilic pneumonia after Cubicin was restarted.

FDA also identified 36 possible cases of eosinophilic pneumonia associated with Cubicin use. Although these cases did not meet the full criteria for a likely case of eosinophilic pneumonia associated with Cubicin, they do provide additional support for an association between use of Cubicin and development of eosinophilic pneumonia.

Based on FDA's review, there appears to be a temporal association between Cubicin administration and the development of eosinophilic pneumonia. Eosinophilic pneumonia may lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed. FDA requested that Cubist, the manufacturer of the product, revise the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the Cubicin product label to further inform health care professionals of this association.

Editor's comment. It is well known that daptomycin should not be used for treatment of bacterial pneumonia because it is inhibited by pulmonary surfactant. Now we are alerted to a complication of pneumonia actually caused by daptomycin. (D.K.)

Quadrivalent HPV Vaccine Safe and Effective in Men

22 July 2010 (Reuters Health [Karla Gale])—The quadrivalent human papillomavirus (HPV) vaccine (Gardasil) prevents infection and disease in men, according to data presented at AIDS 2010 in Vienna.

In fact, the efficacy data were so good that the United States Food and Drug Administration stopped the trial early so that men in the placebo group could get the vaccine, said presenter Dr Heiko Jessen from Berlin, Germany.

Infection with oncogenic HPV can cause cancers of the penis, anus, and head and neck in men, and AIDS substantially increases the risk of HPV-related invasive cancers. Earlier this year the United States Centers for Disease Control and Prevention issued a “permissive recommendation” for HPV vaccination in males ages 9 through 26.

The randomized, double-blind, placebo-controlled trial started out with >4000 healthy men aged 16 to 26 years from 18 countries. The per-protocol analysis, reported here, involved 1400 men (including 200 men who have sex with men) in each arm followed for 3 years, Dr Jessen said.

As noted in their meeting abstract, the researchers detected 3 external genital lesions related to HPV types 6, 11, 16, or 18 in the vaccine arm and 31 in the placebo arm—primarily condylomata acuminate—for an efficacy of 90.4%.

Efficacy against HPV vaccine types was 85.6%, and against HPV DNA detection at any time was 44.7%.

“People who are immune may still have HPV DNA,” Dr Jessen said, but the significance is unknown.

There were no cases of penile, perianal, or perineal intraepithelial neoplasia, but one wouldn't expect these in young healthy men during a short follow-up trial, he added. The research team will continue to follow the participants.

“For now it makes sense to give the HPV vaccine to boys and men ages 9 to 26,” Dr Jessen said, but his group intends to examine its efficacy in older men as well, particularly in men who have sex with men, who are at higher risk for HPV-related malignancy.

There were no serious vaccine-related adverse experiences, he added.

The study was funded by Merck, which manufactures the vaccine.

Prevention and Control of Influenza with Vaccines

Summary of Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010.

This report updates the 2009 recommendations by Centers for Disease Control and Prevention (CDC)'s ACIP regarding the use of influenza vaccine for the prevention and control of influenza (Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2009; 58[RR-8]. Use of influenza A (H1N1) 2009 monovalent vaccine—recommendations of the Advisory Committee on Immunization Practices [ACIP], 2009. MMWR 2009;58[RR-10]). The 2010 influenza recommendations include new and updated information. Highlights of the 2010 recommendations include (1) a recommendation that annual vaccination be administered to all persons aged ⩾6 months for the 2010-2011 influenza season; (2) a recommendation that children aged 6 months-8 years whose vaccination status is unknown or who have never received seasonal influenza vaccine before (or who received seasonal vaccine for the first time in 2009–2010 but received only 1 dose in their first year of vaccination) as well as children who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine regardless of previous influenza vaccine history should receive 2 doses of a 2010–2011 seasonal influenza vaccine (minimum interval: 4 weeks) during the 2010–2011 season; (3) a recommendation that vaccines containing the 2010–2011 trivalent vaccine virus strains A/California/7/2009 (H1N1)-like (the same strain as was used for 2009 H1N1 monovalent vaccines), A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens be used; (4) information about Fluzone High-Dose, a newly approved vaccine for persons aged ⩾65 years; and (5) information about other standard-dose newly approved influenza vaccines and previously approved vaccines with expanded age indications. Vaccination efforts should begin as soon as the 2010–2011 seasonal influenza vaccine is available and continue through the influenza season. These recommendations also include a summary of safety data for United States—licensed influenza vaccines. These recommendations and other information are available at CDC's influenza Web site (http://www.cdc.gov/flu); any updates or supplements that might be required during the 2010–2011 influenza season also will be available at this Web site. Recommendations for influenza diagnosis and antiviral use will be published before the start of the 2010–2011 influenza season. Vaccination and health care providers should be alert to announcements of recommendation updates and should check the CDC influenza Web site periodically for additional information.