Mold in Homes Doubles Risk of Asthma
Exposure to mold and dampness in homes as much as doubles the risk of asthma development in children, according to a
study published today in the March issue of the peer-reviewed journal Environmental Health Perspectives (EHP). Researchers
studied 1,984 Finnish children aged 1 to 7 years over a six-year period to see if they developed asthma. Data collection
included a baseline survey administered in March 1991, as well as a follow-up survey in March 1997, asking questions about
the child’s health, parents’ health, parent’s highest education level, and details of the child’s environment including
exposure to environmental tobacco smoke and presence of feathery or furry pets.
The study focused particularly on four indicators or moisture or mold in the home, including mold odor, visible mold, visible
moisture, and history of water damage. The presence of mold odor proved to be the only significant indicator of asthma
development.
A a total of 138 children, or 7.2% of the study population, developed asthma during the study period. Having a parent with a
history of allergies increased susceptibility in children. Mold odor increased the risk, the study found, independent of
parents’ medical histories. In fact, children living in homes with mold odor during the initial study period were more than
twice as likely to develop asthma in the following 6 years.
“These findings strengthen evidence that exposure to molds increases the risk of developing asthma in childhood,” says lead
author Jouni Jaakkola, director of the University of Birmingham’s Institute for Occupational and Environmental Medicine.
“They also show the importance of heredity-children of parents with asthma have a two-fold risk of asthma compared with
children of nonasthmatic parents.”
Children who were exposed to moisture or mold in the home were also slightly more likely to be exposed to environmental
tobacco smoke, to have feathery or furry pets, and to have parents with a lower education level. The study adds to the body
of evidence linking asthma with exposure to cigarette smoke.
“This study is important for families everywhere,” says Dr. Jim Burkhart, science editor for EHP. “Anyone with young children
in the home should be aware of the potentially harmful effects of long-term exposure to mold and this potential link to
asthma in children.”
In addition to Jaakkola, contributing authors included Bing-Fang Hwang of the Environmental Epidemiology Unit at the
University of Helsinki in Finland, and Niina Jaakkola of the Department of Health Care Administration at Diwan College of
Management in Taiwan. The article is available free of charge at CLICK HERE.
Funding sources for the research as reported by the authors included the Ministry of the Environment, the National Agency for
Welfare and Health, the Medical Research Council of the Academy of Finland, and The Yrjц Jahnsson Foundation.
EHP is published by the National Institute of Environmental Health Sciences, part of the U.S. Department of Health and Human
Services. EHP is an Open Access journal. More information is available online at ehponline.
Environmental Health Perspectives (NIEHS)
PO Box 12233, MD EC-15
Research Triangle Park, NC 27709-2233
USA
Phone 919-541-2359
niehs.nih/drcpt/ehpb/home.htm
Asthma relapse in children common, possible risk factors identified
One third of children in asthma remission at age 18 will relapse by age 26 –
One-third of children with asthma who go into remission by the age of 18 will relapse and redevelop asthma by the time they
are 26, says a new study published in the March issue of CHEST, the peer-reviewed journal of the American College of Chest
Physicians. The findings also suggest that children with certain common allergies, such as house dust mite sensitivity,
and/or poor lung function are more likely to redevelop asthma following remission.
“While we cannot definitively explain why some individuals experience asthma relapse and others do not, we found that
persistence of asthma and asthma relapse are significantly increased in children with house dust mite sensitivity,” said
study author, Malcolm R. Sears, MB, ChB, FRCPC, McMaster University, Hamilton, Ontario, Canada. “This is likely due to
persistent inflammation and genetic factors.”
In a longitudinal, population-based, cohort study of 1,037 children born in New Zealand between 1972 and 1973, researchers
from Dunedin, New Zealand, and Hamilton, ON, Canada, looked at factors that influenced the reoccurrence of asthma by early
adulthood. Study participants were given respiratory questionnaires and spirometry testing at ages 9, 11, 13, 15, 18, 21, and
26, as well as additional lung function and allergen skin-prick testing at select ages. Of 868 patients evaluated at age 18,
176 (20.3 percent) had physician-diagnosed asthma during childhood, and, of those, 68 (38.6 percent) no longer experienced
any asthma symptoms (measured by self-reported wheezing). During an eight-year follow-up period, researchers found that 24 of
the 68 study participants (35 percent) who had previously gone into remission, relapsed by age 26. Although not statistically
significant, the patients who relapsed more often had allergies to house dust mites, grass, cats, dogs, and mold; poorer lung
function (measured by FEV1/FVC ratios at age 18); and increased frequency of responsiveness to methacholine or bronchodilator
at age 21.
“I think that if our patient database was larger or if the study period was longer, our findings that atopy and poor lung
function predict the likelihood of relapse in the future would prove to be true at statistically significant levels,” said
Dr. Sears. “By not smoking and avoiding occupations that increase the likelihood of developing asthma, patients can help
protect themselves from asthma relapse.”
The study also found that children who were more sensitive to house dust mites and cat allergens and/or had poor lung
function were significantly less likely to experience asthma remission by the time they were age 18. Of those in remission at
age 18, the poorer their lung function, the more likely they were to relapse. For those who relapsed by age 21 or 26, their
asthma was generally milder than patients who had persistent asthma throughout their childhood and into adulthood. Nine
percent of those without prior asthma or wheezing by the age of 18 developed adult asthma by the time they were 26 years of
age.
“This study demonstrates the role that specific risk factors have on asthma remission,” said Paul A. Kvale, MD, FCCP,
President of the American College of Chest Physicians. “As specialists who see these patients regularly, we must develop
management programs to reduce the likelihood of relapse.”
CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at chestjournal. ACCP represents 16,000 members who
provide clinical respiratory, sleep, critical care, and cardiothoracic patient care in the United States and throughout the
world. The ACCP’s mission is to promote the prevention and treatment of diseases of the chest through leadership, education,
research, and communication. For more information about the ACCP, please visit the ACCP Web site at chestnet.
Contact: Arielle Green
agreenchestnet
847-498-8387
American College of Chest Physicians
chestnet
Cockroach allergens have greatest impact on childhood asthma in many US cities
New results from a nationwide study on factors that affect asthma in inner-city children show that cockroach allergen
appears to worsen asthma symptoms more than either dust mite or pet allergens. This research, funded by the National
Institute of Environmental Health Sciences (NIEHS) and the National Institute of Allergy and Infectious Diseases (NIAID),
part of the National Institutes of Health, is the first large-scale study to show marked geographic differences in allergen
exposure and sensitivity in inner-city children. Most homes in northeastern cities had high levels of cockroach allergens,
while those in the south and northwest had dust mite allergen levels in ranges known to exacerbate asthma symptoms.
The study results are published in the March issue of the Journal of Allergy and Clinical Immunology.
“These data confirm that cockroach allergen is the primary contributor to childhood asthma in inner-city home environments,”
said NIEHS Director Kenneth Olden, Ph.D. “However, general cleaning practices, proven extermination techniques and consistent
maintenance methods can bring these allergen levels under control.”
Cockroach allergens come from several sources such as saliva, fecal material, secretions, cast skins, and dead bodies. People
can reduce their exposure to cockroach allergen by eating only in the kitchen and dining room, putting non-refrigerated items
in plastic containers or sealable bags, and taking out the garbage on a daily basis. Other measures include repairing leaky
faucets, frequent vacuuming of carpeted areas and damp-mopping of hard floors, and regular cleaning of counter tops and other
surfaces.
NIH provided $7.5 million to researchers at the University of Texas Southwestern Medical Center at Dallas and seven other
research institutions, including the Data Coordinating Center at Rho, Inc., for the three-year study.
“We found that a majority of homes in Chicago, New York City and the Bronx had cockroach allergen levels high enough to
trigger asthma symptoms, while a majority of homes in Dallas and Seattle had dust mite allergen levels above the asthma
symptom threshold,” said Dr. Rebecca Gruchalla, associate professor of internal medicine and pediatrics at the University of
Texas Southwestern Medical Center and lead author of the study.
“We also discovered that the levels of both of these allergens were influenced by housing type,” noted Gruchalla. “Cockroach
allergen levels were highest in high-rise apartments, while dust mite concentrations were greatest in detached homes.”
While cockroach allergen exposure did produce an increase in asthma symptoms, researchers did not find an increase in asthma
symptoms as a result of exposure to dust mite and pet dander. “Children who tested positive for, and were exposed to,
cockroach allergen experienced a significant increase in the number of days with cough, wheezing and chest tightness, number
of nights with interrupted sleep, number of missed school days, and number of times they had to slow down or discontinue
their play activity,” said Gruchalla.
While cockroaches are primarily attracted to water sources and food debris, house dust mites, microscopic spider-like
creatures that feed on flakes of human skin, reside in bedding, carpets, upholstery, draperies and other “dust traps.” Dust
mite allergens are proteins that come from the digestive tracts of mites and are found in mite feces.
Researchers tested 937 inner-city children with moderate to severe asthma symptoms. The children, ages 5 to 11, were given
skin tests for sensitivity to cockroach and dust mite allergens, pet dander, and mold. Bedroom dust samples were analyzed for
the presence of each allergen type.
This study was part of the larger Inner-City Asthma Study, a cooperative multi-center project comprised of seven asthma study
centers across the country. The goal of the study was to develop and implement a comprehensive, cost-effective intervention
program aimed at reducing asthma incidence among children living in low socioeconomic areas.
The National Institute of Environmental Health Sciences is a federal agency that conducts and funds basic research on the
health effects of exposure to environmental agents.
For more information, please contact John Peterson, public affairs specialist with the NIEHS Office of Communications, at
(919) 541-7860, or call Anne Oplinger, writer/editor with the National Institute of Allergy and Infectious Diseases’ Office
of Communications, at (301) 402-1663.
Contact: John Peterson
peterso4niehs.nih
919-541-7860
NIH/National Institute of Environmental Health Sciences
niehs.nih
Cigarette smoke worsens respiratory infections in infants
RSV more severe in children who live with smokers –
Studying Respiratory Syncytial Virus (RSV) to learn what puts children at risk for the most severe infections, Washington
University researchers at St. Louis Children’s Hospital found that a child’s age at the time of infection and whether that
child lives with a smoker could mean the difference between the sniffles and the intensive care unit.
RSV infection is common in children but sometimes can be hard for parents to recognize. By two years of age, 95 percent of
all children have been exposed to RSV, but the symptoms can range from a mild cold all the way to serious pneumonia, which
requires a child to be hospitalized and placed on a ventilator. The Washington University researchers have been trying to
learn why some kids have a relatively easy time while others get so very sick.
The research team has been following 206 children since they were hospitalized or treated in the Emergency Department at St.
Louis Children’s Hospital. The children are part of a project called the RSV Bronchiolitis in Early Life (RBEL) study. The
infants all were under 12 months of age when they were enrolled in the RBEL study and had a wide range in the severity of
their RSV infection, according to Mario Castro, M.D., associate professor of medicine and pediatrics at Washington University
School of Medicine and principal investigator of the RBEL study.
After the children were treated at the hospital and recruited into the study, Castro and colleagues looked at medical records
and measured the children’s oxygen saturation levels during RSV infection. The lower the oxygen saturation, the more serious
the infection. Later, they went to the children’s homes and vacuumed up dust and allergens to see whether those products
might have played a role in the severity of RSV infections.
Researchers asked the babies’ mothers detailed questions about their pregnancies, including whether or not they smoked
cigarettes either before or after giving birth. And they asked mothers about their own problems with allergies and asthma.
The idea was to learn about several potential risk factors to determine why RSV affects some children so severely.
“What we’re trying to study isn’t the likelihood of getting the disease because it seems just about every kid gets RSV,”
Castro says. “We wanted to learn what factors are driving these severe, life-threatening infections.”
Not surprisingly, one of the most important risk factors for severe infection was exposure to cigarette smoke.
“Smoking in the household is really detrimental to these kids,” Castro says. “The kids who lived with mothers or others who
smoked developed more severe RSV infections than the kids who were not exposed to cigarette smoke.”
The study found that 28 percent of the children in the study lived with a mother who smoked. A total of 40 percent lived in a
house where at least one person smoked. And Castro says those children had more severe infections. But somewhat surprisingly,
smoking during pregnancy didn’t seem to increase the risk of severe infection.
“It’s a great thing not to smoke during pregnancy,” Castro says, “but it’s equally important not to smoke after pregnancy.
Kids spend a lot of time with their mothers during the first few months of life, and if the mother is smoking, it’s going to
be detrimental to the child’s health.”
Age is another risk factor for serious RSV infection. The younger the child, the more serious the infection tended to be.
Castro blames that increase in risk on lung and airway development. The tiny windpipes of small children can become clogged
with mucous and other secretions more easily than the bigger, more developed airways of older children.
Surprisingly, the RBEL study also found that African-American children tended to have less serious infections than Caucasian
children. Because RSV infection is linked to childhood asthma and because African-Americans are more likely to suffer from
asthma and to be hospitalized because of it, Castro and colleagues hypothesized that African-American children would be at
increased risk for serious RSV infection. But the study showed just the opposite.
Another surprise was that children who came from homes with the highest levels of allergens had no effect on the severity of
RSV infection. The researchers measured levels of dog and cat allergen, two types of dust mites and cockroach allergen, all
of which have been linked to allergy and asthma problems in older children and adults.
“We were thinking that the kids who came from homes that had high allergen levels would already be compromised because they
would have a reaction to those allergens and develop inflammation in their windpipes, so they would tend to do worse with
RSV,” Castro says. “But we found that even in the kids who came from the homes with the highest allergen levels, there was no
increased risk.”
Having a mother with allergies or asthma also tended to have a protective effect. Those children whose mothers had allergies
or asthma tended to have less serious RSV infections.
That’s somewhat surprising because the virus has been linked to the risk for asthma later on in life. As the children in the
RBEL study get older, they will be followed to see if they develop asthma problems.
“We believe the severity of that initial RSV infection has a role in increasing the risk for asthma later in childhood,”
Castro says. But he won’t know for sure until the children get older.
Bradley JP, Bacharier LB, Bonfiglio J, Schechtman KB, Strunk R, Storch G, Castro M. Severity of Respiratory Syncytial Virus
Bronchiolitis is Affected by Cigarette Smoke Exposure and Atopy. Pediatrics, vol.115; pp. 7-14, Jan. 2005.
The full-time and volunteer faculty of Washington University School of Medicine are the physicians and surgeons of
Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and
patient care institutions in the nation, currently ranked second in the nation by U.S. News & World Report. Through its
affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.
Contact: Jim Dryden
jdrydenwustl.edu
314-286-0110
Washington University School of Medicine
medinfo.wustl.edu
Funding awarded for asthma projects
Six local asthma projects have been awarded grants by Asthma UK’s Aline Morny Challenge Fund.
The successful applications included an asthma awareness resource pack for adolescents in Dudley, an information booklet
targeted at Asian children and a community pharmacy project in East Ayrshire that should improve clinical outcomes for people
with uncontrolled asthma.
Launched last year, the Challenge Fund is intended to support innovative community-based initiatives that benefit people with
asthma.
Grants totalling Ј156,000 were awarded to the six projects, chosen from 29 applicants.
‘We were very impressed with the range and quality of applications we received,’ said Simon Selo, Asthma UK’s Assistant
Director of Policy & Service Development.
‘We look forward to seeing the outcomes of all the projects, which should improve quality of life for adults and children
with asthma.’
Read more about the Challenge Fund projects.
asthma/pros/projects.php
Email an asthma nurse specialist
For advice and information on asthma, call the Asthma UK Adviceline (08457 01 02 03, 9am-5pm, Monday-Friday)
This is a press release from Asthma UK
Prevention of bronchospasm – FDA Approves Sepracor’s XOPENEX HFA(TM) Metered-Dose Inhaler
Sepracor Inc
(Nasdaq: SEPR) today announced that the U.S. Food and Drug Administration
(FDA) has approved its New Drug Application (NDA) for XOPENEX HFA(TM)
(levalbuterol tartrate) Inhalation Aerosol, a hydrofluoroalkane (HFA) metered-
dose inhaler (MDI) for the treatment or prevention of bronchospasm in adults,
adolescents and children 4 years of age and older with reversible obstructive
airway disease. Reversible obstructive airway disease includes respiratory
disorders such as asthma and chronic obstructive pulmonary disease (COPD).
“We are extremely pleased that the XOPENEX HFA MDI received first-cycle
approval from the FDA,” said W. James O’Shea, President and Chief Operating
Officer at Sepracor. “We are working diligently to resolve outstanding
manufacturing issues and complete process validation work. It remains our
target to launch XOPENEX HFA around the end of the year, during the peak
asthma season. Upon launch, Sepracor’s sales force, which includes
approximately 1,250 sales professionals, will promote the XOPENEX HFA MDI to
primary care doctors, specialists including allergists and pulmonologists, and
hospitals in the U.S.”
“We are very excited about the XOPENEX HFA MDI approval as this is the
second FDA approval of a Sepracor NDA in the past three months. This is the
shortest FDA approval time for an HFA MDI to date and, we believe, a
reflection of the quality of our MDI program and NDA,” said Mark H.N.
Corrigan, M.D., Executive Vice President, Research and Development at
Sepracor. “We expect that the XOPENEX HFA MDI will make XOPENEX available to
the large number of adult and children asthmatics who prefer the convenience
of an MDI as part of their therapy. This product will also allow those
patients who are currently benefiting from therapy with XOPENEX(R) brand
levalbuterol HCl Inhalation Solution administered by nebulization, to continue
to use XOPENEX when therapy with a hand-held device is appropriate.”
The MDI development program included approximately 1,870 pediatric and
adult subjects and 54 studies (preclinical and clinical). In 2003, Sepracor
completed its Phase III studies of XOPENEX HFA. In each of the three, large-
scale, pivotal Phase III trials that Sepracor conducted, the XOPENEX HFA MDI
was well tolerated and met the targeted efficacy endpoints in both adults and
children with asthma. In the primary airway function measure, FEV1 (a test of
lung function that measures the amount of air forcefully exhaled in one
second), the XOPENEX HFA MDI produced statistically and clinically significant
improvements relative to placebo.
Sepracor’s XOPENEX MDI utilizes state-of-the-art HFA technology and does
not contain a chlorofluorocarbon (CFC) propellant. MDIs are portable, hand-
held devices consisting of a pressurized canister containing medication and a
mouthpiece through which the medicine is inhaled. Each canister provides 200
actuations (or inhalations). Sepracor and 3M Drug Delivery Systems Division
are collaborating under an agreement that includes scale-up, manufacturing and
supply of the XOPENEX HFA. The collaboration combines Sepracor’s short-acting
beta-agonist, XOPENEX, and 3M’s expertise in manufacturing MDIs, the device
most commonly used by patients for the treatment of asthma and COPD.
Sepracor currently markets XOPENEX Inhalation Solution through the
company’s 1,250-person sales force. XOPENEX Inhalation Solution is a short-
acting bronchodilator indicated for the treatment or prevention of
bronchospasm in patients 6 years of age and older with reversible obstructive
airway disease. XOPENEX Inhalation Solution is available for use in a
nebulizer at 0.31 mg and 0.63 mg dosage strengths for treatment of children 6
to 11 years old, and in 0.63 mg and 1.25 mg dosage strengths for patients 12
years of age and older. XOPENEX Inhalation Solution revenues for the twelve
months ended December 31, 2004 were approximately $319.8 million.
Approximately 90 percent of the short-acting beta-agonist inhalers sold in
2004 contained CFC propellants, according to IMS Health information. Under
provisions in the Montreal Protocol on Substances that Deplete the Ozone
Layer, an international agreement that requires the phase-out of substances
that deplete the ozone layer, MDIs containing CFC propellants would be subject
to eventual removal from the marketplace. In June 2004, the FDA issued a
proposed rule for the removal of the essential use exemption for albuterol,
which currently permits the use of CFC-containing albuterol inhalers despite
environmental concerns. Removal of this essential use exemption would prevent
albuterol products containing CFC propellants, including MDIs, from being
marketed in the U.S.
Currently, the U.S. short-acting bronchodilator MDI market potential at
branded prices, assuming parity pricing to branded PROVENTIL(R) HFA, is
approximately $1.8 billion.
Asthma is a chronic lung disorder characterized by reversible airway
obstruction and the pathologic finding of airway inflammation. According to
the 2002 National Health Interview Survey conducted by the Centers for Disease
Control and Prevention, nearly 31 million Americans have been diagnosed with
asthma in their lifetime. It is the most common childhood illness and affects
nearly 9 million children in the U.S. under the age of 18. Short-acting beta-
agonists are the most-prescribed asthma therapy among primary care physicians
and pediatricians in the U.S., according to IMS Health information.
Safety Information
XOPENEX HFA is contraindicated in patients with a history of
hypersensitivity to levalbuterol, racemic albuterol or any other component of
XOPENEX HFA. XOPENEX HFA and other beta-agonists can produce paradoxical
bronchospasm, which may be life threatening. If additional adrenergic drugs,
including other short-acting sympathomimetic aerosol bronchodilators or
epinephrine, are to be administered with XOPENEX HFA by any route, they should
be used with caution to avoid deleterious cardiovascular effects. Due to the
cardiovascular side effects associated with beta-agonists, caution is
generally recommended for patients with cardiovascular disorders (especially
coronary insufficiency, cardiac arrhythmias and hypertension), diabetes,
hyperthyroidism, or convulsive disorders. Also, see the complete prescribing
information regarding potential drug interactions with beta-blockers,
diuretics, digoxin, or MAOI and tricyclic antidepressants.
Please visit sepracor to access the FDA-approved
labeling
text, which will be posted prior to the conference call on Monday, March 14,
2005.
Sepracor will host a conference call and live webcast on Monday, March 14,
2005 beginning at 8:30 a.m. ET. To participate via telephone, dial (612) 326-
1028. Please call ten minutes prior to the scheduled conference call time.
For live webcasting, go to the Sepracor web site at sepracor
and access the For Investors section. Click on either the live webcast link
or microphone icon to listen. Please go to the web site at least 15 minutes
prior to the call in order to register, download, and install any necessary
software. A replay of the call will be accessible by telephone after 12:00
p.m. ET and will be available for approximately one week. To replay the call,
dial (320) 365-3844, access code 773967. A replay of the webcast will be
archived on the Sepracor web site in the For Investors section.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to
treating and preventing human disease through the discovery, development and
commercialization of innovative pharmaceutical products that are directed
toward serving unmet medical needs. Sepracor’s drug development program has
yielded an extensive portfolio of pharmaceutical compound candidates with a
focus on respiratory and central nervous system disorders. The company’s
commercialization efforts are carried out by its U.S.-based, 1,250-person,
primary care and specialty-oriented sales force. Sepracor’s corporate
headquarters are located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risks
and uncertainties, including statements with respect to the successful
development, manufacture and commercial launch of, and the safety, efficacy
and potential benefits of the XOPENEX HFA MDI and the company’s other
pharmaceuticals under development, and expectations with respect to
collaborative agreements. Among the factors that could cause actual results to
differ materially from those indicated by such forward-looking statements are:
unexpected delays in scale-up, manufacture and commercial introduction; the
ability of Sepracor and 3M to collaborate successfully; Sepracor’s ability to
fund and the results of further clinical trials with respect to products under
development; the timing and success of submission, acceptance, and approval of
regulatory filings; the scope of Sepracor’s patents and the patents of others;
the commercial success of Sepracor’s products; the ability of the company to
attract and retain qualified personnel; the performance of Sepracor’s
licensees and other collaboration partners; the availability of sufficient
funds to continue research and development efforts; the continued ability of
Sepracor to meet its debt obligations when due; and certain other factors that
may affect future operating results and are detailed in the company’s
quarterly report on Form 10-Q for the quarter ended September 30, 2004 filed
with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor’s
expectations and beliefs as of the date of this press release. Sepracor
anticipates that subsequent events and developments may cause these
expectations and beliefs to change. However, while Sepracor may elect to
update these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing Sepracor’s expectations
or beliefs as of any date subsequent to the date of this press release.
Xopenex HFA is a trademark and Xopenex is a registered trademark of
Sepracor Inc. 3M is a trademark of 3M Company. Proventil is a registered
trademark of Schering Corporation.
For a copy of this release or any recent release, visit
prnewswire/comp/780960.html or sepracor.
Contact:
David P. Southwell
Executive Vice President
Chief Financial Officer
Jonae R. Barnes
Vice President
Investor Relations
Sepracor Inc.
(508) 481-6700
Sepracor Inc.
sepracor
View drug information on Proventil HFA Inhalation Aerosol; Xopenex.
Cough syrup warning in Canada, twice dextromethorphan dose on some lots
Health Canada is advising consumers across Canada not to use specific brands of “Cough Syrup DM” DIN 02015781 with lot
numbers starting with 2J29 and 3J29 due to the product containing twice the amount of dextromethorphan than is stated on the
label.
At the request of Health Canada, this product is being recalled by the manufacturer, Jamp Pharmaceutical Corp in Langley,
British Columbia. The “Cough Syrup DM” is packaged in 100mL and 250mL plastic bottles. The product is distributed to
retailers across Canada and sold under the following brand names:
– People First
– PharmaChoice
– Procurity Encounter
– ARP Preferred
– Medicine Centre
– United Pharmacy
– Western Family
Consumption of this product may result in light-headedness, fatigue and slurred speech. Children under the age of three may
be more vulnerable to possible adverse effects, including seizures, from this product.
People should return this product to the pharmacy. Individuals who are concerned about their health after consuming this
product are advised to seek medical assistance.
Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
Health Canada
Whooping cough – GSK gets unanimous favorable recommendation by FDA Advisory Committee for Boostrix
Vaccine candidate against pertussis (whooping cough) – A disease children are routinely vaccinated against but which is
still on the rise in the United States.
GlaxoSmithKline (NYSE: GSK) today announced that its booster vaccine candidate, BoostrixTM [Tetanus Toxoid, Reduced
Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] received a unanimous favorable recommendation from the
Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA). Currently, there
is no pertussis vaccine approved for use in the U.S. for children seven years of age or older. Immunity from childhood
vaccination generally wears off after five to 10 years, leaving many adolescents susceptible to this highly contagious
disease. If approved, Boostrix would add a pertussis component to the routine tetanus/diphtheria booster currently
recommended for adolescents. The committee’s favorable recommendation, although not binding, will be considered by the FDA in
its final review of the Biologics License Application (BLA) for Boostrix.
Reported cases of pertussis have increased since the mid-1970s. According to the Centers for Disease Control and Prevention
(CDC), there were almost 20,000 cases in 2004 – the highest number of reported cases in more than 40 years. In addition, 39
percent of cases reported to the CDC in 2003 occurred in adolescents 10-19 years of age. Adolescents, in whom classic signs
and symptoms of pertussis are often absent, may go undiagnosed and be the source of infection for susceptible infants and
other family members.
“Pertussis is a serious and growing public health threat, and we are extremely pleased that the FDA Advisory Committee has
provided a unanimous favorable recommendation for FDA approval of Boostrix,” said Barbara Howe, M.D., vice president,
Clinical Research and Development and Medical Affairs, Vaccines North America, GlaxoSmithKline. “If approved, Boostrix would
add a pertussis component to the routine tetanus/diphtheria booster currently administered to adolescents – a population in
which there is a significant disease burden.”
In making its recommendation, the FDA Advisory Committee reviewed several clinical trials which included safety and
immunogenicity data from one pivotal trial, which studied Boostrix in more than 3,000 adolescents in the United States, aged
10 to 18. The Phase III clinical trial showed Boostrix to be comparable to a U.S.- licensed Td vaccine [Tetanus and
Diphtheria Toxoids] with regard to overall safety and immunogenicity. In addition, the use of Boostrix induced anti-pertussis
antibody levels, which were statistically higher than those observed in infants following primary immunization with a DTaP
vaccine (Infanrixв) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed] in whom efficacy against
pertussis disease was demonstrated in a previous study.
In this observer-blinded, randomized, controlled, multi-center clinical trial, 4,114 healthy 10-18-year-olds were vaccinated
with one dose of Boostrix or a U.S.-licensed Td vaccine. Each subject had completed his or her routine childhood vaccinations
against diphtheria, tetanus and pertussis according to the U.S. recommended schedule. According to study results:
– In both treatment groups, > 99.9 percent of subjects had anti-diphtheria and anti-tetanus concentrations > 0.1 IU/ml,
indicating seroprotection against diphtheria and tetanus
– In the Boostrix treatment group, the levels of anti-pertussis antibodies, anti-PT, anti-FHA and anti-PRN were measured and
were statistically higher than pertussis antibody concentrations observed in infants, following primary immunization with a
DTaP vaccine (Infanrixв), in whom efficacy against pertussis disease was previously demonstrated
– The overall safety profile was comparable between the Boostrix and Td groups
“Adolescents are an important reservoir for the disease and often the source of infection for infants,” noted Dr. Colin
Marchant, adjunct associate professor, Boston University School of Medicine, Boston, MA. “Adding pertussis to the current
tetanus and diphtheria booster shot for teens is a logical strategy to prevent this disease in adolescents – without
additional injections – and may help reduce the risk of transmission to infants in whom pertussis can be deadly.”
Background on Pertussis
Pertussis, commonly known as “whooping cough,” is a highly contagious bacterial infection of the respiratory system that
causes spasms of severe coughing. It is spread through airborne droplets of an infected person’s cough or sneeze. The first
symptoms of pertussis are similar to the “common cold” with a mild fever, runny nose and a cough. Symptoms generally progress
to more severe coughing episodes, often with a high-pitched “whoop,” followed by vomiting. Adolescents generally exhibit
different symptoms of the disease, often without the classic “whoop,” making it difficult to diagnose. However, for these
older pertussis sufferers, severe coughing episodes can lead to vomiting, a hernia, or even a broken rib. These severe
coughing episodes can last up to 100 days. While pertussis is threatening to all, this highly contagious disease can be
deadly in infants who are too young to be fully immunized. Up to 90 percent of non-vaccinated susceptible household members
may develop the disease when exposed to people infected with pertussis.
Pertussis, which is under-reported and under-recognized, is a common cause of prolonged cough illness in adolescents and
adults. In fact, in a clinical study involving 442 adolescents and adults who had a cough-related illness for more than seven
days, approximately 20 percent of these patients had laboratory-documented pertussis.
In addition to the public health threat pertussis poses, the disease also has economic repercussions. A cost-benefit analysis
for the use of a pertussis booster vaccine in adolescents projected that vaccination of people in the U.S. ages 10-19 during
a 10-year period would prevent up to 1.8 million cases of pertussis and save as much as $1.6 billion in direct and indirect
costs.
“With nearly two million doses of Boostrix distributed worldwide since 1999, GlaxoSmithKline is extremely pleased that our
efforts to develop a booster vaccine for pertussis in the U.S. have resulted in a favorable recommendation from the FDA
Advisory Committee,” said David M. Pernock, senior vice president Pharmaceuticals, Philadelphia & Vaccines, GlaxoSmithKline.
“As a leader in combination vaccines, GlaxoSmithKline will be proud to introduce Boostrix as the first of a number of new and
important candidate vaccines from our pipeline specifically targeted at preventing disease in adolescents.”
Background on Diphtheria and Tetanus
Diphtheria is a serious disease that results in the death of approximately five to 10 percent of infected persons, with
higher death rates (up to 20 percent) in persons younger than five and older than 40 years of age. Initial symptoms may
include malaise, sore throat and low-grade fever. As the disease progresses, a membrane can form over the airway and result
in respiratory obstruction which can lead to death. Other complications may include heart failure and paralysis. Most cases
of diphtheria occur among unvaccinated or inadequately vaccinated persons.
Tetanus (lockjaw) is a severe, often fatal disease. The bacteria that cause tetanus are widely found in soil and the manure
of many animals. Almost all reported cases of tetanus are in persons who have either never been vaccinated, or who completed
a primary series, but have not had a booster in the preceding 10 years. Infants of unvaccinated mothers are at risk for
neonatal tetanus. Early symptoms are lockjaw, stiffness in the neck and abdomen, and difficulty swallowing. Later symptoms
may include fever, elevated blood pressure and severe muscle spasms.
GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, N.C., is one of the world’s leading
research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling
people to do more, feel better and live longer.
GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors
that any forward-looking statements or projections made by the company, including those made in this Announcement, are
subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may
affect the Group’s operations are described under ‘Risk Factors’ in the Operating and Financial Review and Prospects in the
company’s Annual Report on Form 20-F for 2004.
Contact: Amanda Foley
919-483-2839
Cohn & Wolfe
cohnwolfe/home.asp
New Report Details Alarming Lung Disease Disparities in Hispanic Communities, USA
American Lung Association Links Socio-Economic Factors to Environmental Health Hazards –
The Hispanic community is disproportionately exposed to environmental hazards such as air pollution, according to a new study
by the American Lung Association. The report, Lung Disease Data in Culturally Diverse Communities, provides a definitive
link between air pollution and lung disease prevalence in communities of color.
“In many instances, Hispanic communities are disproportionately affected by environmental exposures, which can lead to a host
of lung diseases. This publication calls on legislators and community leaders to fight for stricter air pollution standards,
said Donald Woods, Vice President of Cultural Diversity for the American Lung Association. “The American Lung Association is
committed to educating these communities about lung disease and achieving our mission to eliminate lung disease and promote
lung health.”
Lung Disease Data in Culturally Diverse Communities shows that Hispanics and African Americans together suffer
disproportionately from asthma, compared to Whites, and provides important information about clean air and the long-term
effects of exposure to tobacco smoke and air pollution. The report calls attention to the health disparities and other
socioeconomic factors that may account for the high prevalence rates within diverse communities.
According to the report, lung disease affects people of all cultures, races, and ethnicities, but some groups have higher
rates than others. The study shows that Hispanics are more than twice as likely as either African Americans or Whites to
live near high traffic areas such as freeways and other areas with heavy diesel truck traffic. These areas have higher
levels of air pollution and increase the risk of lung disease and premature death. Studies have shown that Puerto Ricans may
have higher asthma prevalence rates and higher death rates than other Hispanic subgroups and non-Hispanic Whites.
Click here for the Lung Disease Data in
Culturally Diverse Communities: 2005 report
About the American Lung Association
For 100 years, the American Lung Association has been the lead organization working to prevent lung disease and promote lung
health. Lung disease death rates continue to increase while other leading causes of death have declined.
The American Lung Association funds vital research on the causes of and treatments for lung disease. With the generous
support of the public, the American Lung Association is “Improving life, one breath at a time.”
For more information about the American Lung Association or to support the work it does, call 1-800-LUNG-USA (1-800-586-4872)
or log on to lungusa.
American
Lung Association
For Children With Hearing Loss, The Earlier The Better For Cochlear Implants
Receiving a cochlear implant before 18 months of age dramatically improves a deaf child’s ability to hear, understand and, eventually, speak, according to a multicenter study led by scientists at Johns Hopkins.
The study, published in the April 21 issue of the Journal of the American Medical Association (JAMA), is believed to be the first nationwide look at the impact of surgical timing on the success rate of the implants. The surgery consists of placing a small electronic device into the ear that bypasses the inner ear’s damaged nerve cells and transmits sound signals to the brain.
The researchers followed 188 children, ages 6 months to 5 years, with profound hearing loss for three years after receiving cochlear implants at six U.S. hospitals. They tracked the children’s newly emerging ability to recognize speech after the implant, and compared their levels of language development to those of 97 same-age children with normal hearing.
While speech and language skills improved in all children regardless of age after they received a cochlear implant, age emerged as a powerful predictor in just how much improvement was seen. The finding points to a critical window for diagnosis and treatment, one that does not stay open for very long. Therefore, the researchers say, delaying implantation deprives children of essential exposure to sounds and speech during the formative phases of development when the brain starts to interpret the meaning of sounds and speech.
“We identified a clear pattern where implantation before 18 months of age conferred a much greater benefit than later implantation, allowing children to catch up fast, sometimes to nearly normal levels,” says lead investigator John Niparko, M.D., director of Otolaryngology Head & Neck Surgery at Johns Hopkins. “Delaying intervention until a child loses every last bit of hearing deprives the brain of much-needed sound and speech stimulation that is needed to develop language.”
Each year of delay, the investigators say, can put a child a year behind in language development. Therefore all young infants with suspected hearing loss, and those with family history, should be monitored vigilantly and referred for treatment immediately, they say.
Even though the children in the study never reached the language levels of their hearing counterparts, those who received cochlear implants developed a decidedly better ability to understand and speak than they would have without the device, the researchers found.
Indeed, when researchers looked at children of all ages, their ability to understand speech grew twice as fast as it would have been expected to without the device (10.4 vs. 5.4). Their ability to communicate back, either with words or other age-appropriate modes of expression, grew nearly one and a half times faster than it would have without an implant (8.4 vs. 5.8).
Children who received a cochlear implant before age 18 months nearly caught up with their normal-hearing counterparts over the subsequent three years. Children who received implants after age 3 had language gaps that corresponded directly to the length of delay before receiving the implant.
The study also showed that children implanted before age 18 months managed to reach speech and language developmental milestones much faster than those who received their implants later, revealing gaps between a child’s chronological and language ages. For example, children with normal hearing reached a key speech comprehension milestone at age 27 months, on average, and children who received an implant before age 18 months did so around age 3 years. But those who received an implant after they turned 18 months and before they were 3, reached that milestone 15 months later than children who received an implant before age 18 months. Those who received an implant after age 3 did not reach the milestone until nearly two years later, on average, when compared with children who received an implant before 18 months of age.
When researchers looked at verbal expression milestones, a similar pattern of delay emerged. The gap between chronologic age and language age grew wider the later a child underwent implantation.
Another important factor in language development was how soon and how much the parents interacted with a child, the study found.
“The impact of early cochlear implantation was greatly augmented in children whose caregivers use language to engage them,” Niparko said. “And we cannot overestimate the importance of caregiver communication with babies at a very early age, whether they have some degree of hearing loss or normal hearing.”
Co-investigators on the study include Emily Tobey, Ph.D., Donna Thal, Ph.D., Laurie Eisenberg, Ph.D., Nae-Yuh Wang, Ph.D., Alexandra Quittner, Ph.D., Nancy Fink, M.P.H.
The other institutions involved in the study were the House Ear Institute in Los Angeles, University of Miami, University of Michigan, University of North Carolina, University of Texas at Dallas, and the River School in Washington, D.C.
The research was funded by the National Institute on Deafness and Other Communication Disorders, by the CityBridge Foundation and by the Sidgmore Family Foundation.
Niparko serves without compensation on the advisory boards for two cochlear implant manufacturers, Advanced Bionics Corporation and the Cochlear Corporation. He also serves on the boards of directors of two schools for children with hearing loss that received gifts from the cochlear implant manufacturers. The terms of these arrangements are being managed by the Johns Hopkins University in accordance with its conflict-of-interest policies.
Source: Johns Hopkins Medicine