www.criteriuminc.comMARCH 2010

 This Month's Clinical Focus: Asthma & Allergy

 Penicillin Allergy Might Not Include Related Antibiotic
Many facing surgery could still take cephalosporins if tested, study finds.

Most patients who have a history of penicillin allergy can safely take antibiotics called cephalosporins, U.S. researchers say. Cephalosporins -- which are related to penicillin in their structure, uses and effects -- are the most frequently prescribed class of antibiotics.

"Almost all patients undergoing major surgery receive antibiotics to reduce the risk of infections. Many patients with a history of penicillin allergy don't get the cephalosporin because of a concern of possible drug reaction. They might get a second-choice antibiotic that is not quite as effective," study author Dr. James T. Li, of the Mayo Clinic in Rochester, Minn., said in a news release from the American Academy of Allergy, Asthma & Immunology.


He and his colleagues conducted penicillin allergy skin tests on 178 patients who reported a history of severe allergic (anaphylactic) reaction to penicillin. The tests yielded 10 unclear results, 12 positive results, and 156 negative results.

Later, 80 of the 156 patients with negative skin tests to penicillin received a cephalosporin when they had surgery. Just one patient experienced a possible mild adverse reaction to the cephalosporin.

"Even patients with a history of a serious reaction to penicillin can receive cephalosporins safely if the allergy tests are negative," Li said. "The main message here is that patients with a history of penicillin allergy who need surgery can benefit from consultation with an allergist. They can get the best antibiotic with the lowest risk of drug reaction."
SOURCE: American Academy of Allergy, Asthma & Immunology



 Meat Might Be Behind Unidentified Allergic Reactions

Certain carb could be causing severe anaphylaxis, researchers warn
A carbohydrate in meat called alpha-gal may be the unrecognized cause of recurring severe allergic reactions in some patients, a new study suggests.

The study included 60 people in Australia and the United States who experienced the recurrent severe allergic reaction known as anaphylaxis with no known cause. Allergy tests revealed that 25 of the 60 patients had positive responses to alpha-gal. A positive response was considered a level of greater than 1.0 international units per milliliter of immunoglobulin E (IgE).

The tests did not identify any other allergens that would explain the cause of anaphylaxis in the 25 patients who were positive for alpha-gal or in the other 35 patients, the study authors noted.

"These studies continue to suggest not only that IgE to a carbohydrate has important clinical implications in food allergy and anaphylaxis, but that the presence of this antibody may well have been under-appreciated in terms of the number of patients affected and the geographical scope," study author Dr. Scott P. Commins, of the University of Virginia, said in an academy news release. A person who suffers an anaphylactic reaction to something unknown is at increased risk for recurring anaphylaxis if the trigger isn't identified.
SOURCE: American Academy of Allergy, Asthma & Immunology

 FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema
The U.S. Food and Drug Administration approved Kalbitor (ecallantide) on Dec. 1 to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

HAE is caused by a defect in the blood protein C1 esterase-inhibitor, which plays a role in regulating how certain immune system and blood clotting pathways function. Decreased function of this protein can lead to rapid and serious swelling of the face or other parts of the body, which may result in permanent disfigurement, disability or death.  Swelling of the digestive tract may cause excruciating abdominal pain, nausea, and vomiting, while airway swelling puts patients at risk of suffocation. About 10,000 people in the United States have HAE.

"Kalbitor offers another potentially life-saving option for those people with HAE," said John Jenkins, M.D., director, Office of New Drugs, in the FDA's Center for Drug Evaluation and Research. "FDA is committed to facilitating the development and approval of safe and effective therapies for patients with rare conditions."

This is the second drug marketed in the United States to treat HAE attacks. In October 2009 the FDA approved Berinert, a C1-inhibitor derived from blood plasma to treat facial and abdominal attacks of HAE.

Kalbitor is a liquid that is intended to be injected under the skin for patients age 16 and older who experience HAE attacks.

The medication's most serious side effect is anaphylaxis, a severe allergic reaction that can close a person's airways and stop them from breathing. Other side effects include headache, nausea, diarrhea, swelling in the nose and throat, fever, and skin irritations.

Kalbitor should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis. The drug is marketed by Dyax Corp., Cambridge, Mass. The second HAE drug, Berinert, is marketed by CSL Behring Inc., Marburg, Germany.
Source: FDA News Release


 If you want to accelerate your clinical trials,
 you need to change the workflow paradigm.

Criterium knows resources are precious, time is the enemy, and results are paramount. Our user-friendly technologies are integrated into all aspects of our clinical development services for improved efficiencies. And a talented in-house staff that is committed to the professional support of our clients individual and particular needs is the backbone of our processes for maximum client outcomes.

 We have managed successful clinical trials for 
 over 19 years.

Of particular interest to you would be our experience with ASTHMA & ALLERGY TRIALS, including:  Adult and Pediatric Asthma, COPD, Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis, Bacterial Sinusitis, & Allergic Conjunctivitis.

 We have several propriety technology solutions 
 that are proven to improve your clinical trial results.
Contact: John Hudak, President at
jmhudak@criteriuminc.com

WHAT'S NEW AT CRITERIUM:
 CRITERIUM, Inc. Global CRO Releases New Whitepaper
June 15, 2009

 
CRITERIUM, Inc. Global CRO Offers "A La Carte" Service Structure
April 15, 2009
   CRITERIUM, Inc. Global CRO Expands Services to Canada
February 2, 2009

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