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Thu Dec 9 03:57:02 EST 2010


OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral
Infant Medicines"
●	Potential misuse of these infant medicines, not product safety,
is driving the voluntary withdrawal 
●	This withdrawal does not affect cough and cold medicines for
children age 2 and older 
●	Further evaluation of these oral cough and cold medicines for
infants and children will occur at the October 18 and 19 FDA advisory
committee meeting
The Consumer Healthcare Products Association (CHPA) on behalf of the
leading makers of over-the-counter cough and cold medicines today
announced voluntary market withdrawals of oral cough and cold medicines
that refer to "infants." The voluntary withdrawal affects only these
"infant" oral medicines, not those intended and labeled for use in
children age two and older. The branded cough and cold medicines that
are being voluntarily withdrawn are:
●	Dimetapp® Decongestant Plus Cough Infant Drops 
●	Dimetapp® Decongestant Infant Drops 
●	Little Colds® Decongestant Plus Cough 
●	Little Colds® Multi-Symptom Cold Formula 
●	PEDIACARE® Infant Drops Decongestant (containing
pseudoephedrine) 
●	PEDIACARE® Infant Drops Decongestant & Cough (containing
pseudoephedrine) 
●	PEDIACARE® Infant Dropper Decongestant (containing
phenylephrine) 
●	PEDIACARE® Infant Dropper Long-Acting Cough 
●	PEDIACARE® Infant Dropper Decongestant & Cough (containing
phenylephrine) 
●	Robitussin® Infant Cough DM Drops 
●	Triaminic® Infant & Toddler Thin Strips® Decongestant 
●	Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough

●	TYLENOL® Concentrated Infants' Drops Plus Cold 
●	TYLENOL® Concentrated Infants' Drops Plus Cold & Cough 
CHPA says that this voluntary withdrawal does not affect medicines
intended for children age two and older. CHPA and its member companies
have put forth recommendations to the U.S. Food and Drug Administration
(FDA) to strengthen the labels on all oral OTC children’s cough and
cold medicines from "ask a doctor" before using to "do not use" in
children under two years. CHPA made these recommendations to the FDA in
preparation for a joint FDA advisory committee meeting on October 18 and
19. These recommendations, as well as several additional
recommendations, including those proposed by FDA review staff, will be
explored further at this meeting. For more information, go to 
http://www.chpa-info.org/ChpaPortal/PressRoom/NewsReleases/2007/10_11_07_CCMedicines.htm


NB: This voluntary recall most probably preempts a mandatory recall
from FDA!!!

PRO INCREASED FISH CONSUMPTION: For Pregnant Women, Benefits of Eating
Ocean Fish Outweigh Concerns from Trace Levels of Mercury: Experts in
Obstetrics and Nutrition Unveil Seafood  A Maternal Nutrition Group
comprised of professors of obstetrics and doctors of nutrition from
across the country, in partnership with the National Healthy Mothers,
Healthy Babies Coalition (HMHB), unveiled NEW recommendations for
seafood consumption during pregnancy. The recommendations come at a time
when the debate about mercury in fish and an FDA/EPA advisory have
created confusion for pregnant women, causing a reduction in their fish
consumption. The Group says that shis leads to inadequate intake of
omega-3 fatty acids resulting in risks to their health and the health of
their children. This inadequate intake of fish is confirmed by data from
the National Health and Nutrition Examination Survey (NHANES), which
shows that 90 percent of women are consuming less than the
FDA-recommended amount of fish. To read more, go to
http://www.hmhb.org/oceanfishpr.html 

CON: March of Dimes Position on Seafood UNCHANGED
 The March of Dimes says that its position regarding seafood
consumption for pregnant women remains unchanged.  They continue to
recommend that pregnant and nursing women eat no more than a maximum
each week of 12 ounces of fish that are low in mercury, such as shrimp,
salmon, pollock, catfish, and canned light tuna; and no more than 6
ounces of white (albacore) tuna in one week, because of the concern that
albacore is high in mercury, which is especially toxic during early
brain development.  MOD says that this position mirrors the
recommendations of the Environmental Protection Agency (EPA) and the
Food & Drug Administration (FDA). 
Pregnant and nursing women should choose fish that are high in omega-3
fatty acids but low in mercury.   Although fish is one source of omega-3
fatty acids, there are others, including eggs from specially-fed hens
and fish oil capsules. 
For more information, go to
http://www.marchofdimes.com/aboutus/22663_27362.asp 

RECALLS!! There are too many recalls due to excessive lead levels in
the paint of children's toys being posted now on the U.S. Consumer
Product Safety Commission website for us to cite them all. To keep up to
date, go to http://www.cpsc.gov/cpscpub/prerel/prerel.html 
Two other large infant product recalls include:

1) in cooperation with Target, of Minneapolis, Minn. the U.S. Consumer
Product Safety Commission today announced a voluntary recall of about
82, 000 Plush Boys Rattles made in China. Consumers should stop using
recalled products immediately unless otherwise instructed. The recalled
rattles can break open releasing the small beads inside, posing a
choking hazard to young children.
To learn more or to view the toy, go to
http://www.cpsc.gov/cpscpub/prerel/prhtml08/08002.html 

2) In cooperation with the U.S. Consumer Product Safety Commission
(CPSC), Kolcraft Enterprises Inc., of Chicago, Ill., is voluntarily
recalling about 425,000 infant play yards following the death of a
child. CPSC received a report of a 10-month old boy who strangled on the
changing table’s restraint strap that was hanging down into
Kolcraft’s “Sesame Beginnings” Travel Play Yard where the child
was located. Twelve different Kolcraft play yards are included in this
recall. All of the play yards have raised changing tables with a
restraint strap that forms a loop beneath the changing table, posing a
strangulation hazard to a child in the play yard. In addition to the
strangulation hazard with the changing table restraint strap, one play
yard also has a raised cradle that rocks back and forth. A child can
roll and get trapped against the side of the cradle in the Contours
3-in-1 Play Yard. If that happens, a child can suffocate. Kolcraft has
received 45 reports of children rolling to the side of the rocking
cradle attachment. The recalled play yards were sold in a variety of
colors and patterns. Play yards and model numbers included in this
recall are listed in the chart below. The model number is printed on a
white sticker located on one of the feet of the play yard. They were
manufactured in China. Consumers should immediately stop using the
changing tables and rocking cradle and contact the firm for instructions
on receiving a free non-looped replacement strap for the changing table
and a free repair kit to secure the base of the cradle. For more
information, go to
http://www.cpsc.gov/cpscpub/prerel/prhtml07/07315.html 



Feedback from some health and advocacy organizations re the SCHIP
veto:
1) American Public Health Association (APHA) Deeply Troubled by Veto of
CHIP Statement from Georges C. Benjamin, MD, FACP, FACEP (E) Executive
Director, American Public Health Association:
 “APHA is deeply troubled that, despite overwhelming support from the
general public and congressional leadership of both parties, President
Bush today vetoed the Children’s Health Insurance Program (CHIP),
which would have provided 10 million children access to health care. 
“We are dismayed by the president’s misguided spending priorities,
which fail to invest in protecting the health of our children. However,
we don’t believe that the fight is over. A bipartisan group of leaders
put great effort into passing a bill that takes important steps towards
protecting the health of our nation’s children in need. 
“APHA, supported by its thousands of members and professional allies,
will continue to support efforts to pass the CHIP legislation. We ask
the Congress to override this presidential veto.”
2) From Children’s Defense Fund (CDF): CDF denounced  veto of
legislation that would have provided health coverage to one-third of the
more than nine million uninsured children in America and urges Congress
not to give up until it covers all children. The House and the Senate
reached agreement last week to reauthorize Children's Health Insurance
Program (CHIP) with new funds to expand and improve the program and
insure an additional 3.1 million low-income children. (You can also Find
out how your Members of Congress voted. At this web site
http://www.childrensdefense.org/site/PageServer ) 
Also see commentary from Children’s Defense Fund: Appalling New
Census Statistics Show Increase of More than 700,000 Uninsured Children
in 2006 at
http://www.childrensdefense.org/site/MessageViewer?em_id=5141.0 

3) Also see Clint Talbott editorial in the Bolder CO Daily Camera
titled Tough Luck Kids at
http://www.commondreams.org/archive/2007/09/30/4216/  Talbott quotes
the US President on need for SCHIP: 
“ I mean, people have access to health care in America. After all,
you just go to the emergency room.”






ARTICLES
OLDS DL et al. Effects of Nurse Home Visiting on Maternal and Child
Functioning: Age-9 Follow-up of a Randomized Trial PEDIATRICS Vol. 120
No. 4 October 2007, pp. e832- e845
The authors set out to test the effect of prenatal and infancy home
visits by nurses on mothers' fertility and children's functioning 7
years after the program ended at child age 2. 
They conducted a randomized, controlled trial in a public system of
obstetric and pediatric care. A total of 743 primarily black women <29
weeks' gestation, with previous live births and at least 2
sociodemographic risk characteristics (unmarried, <12 years of
education, unemployed), were randomly assigned to receive nurse home
visits or comparison services. Primary outcomes consisted of intervals
between births of first and second children and number of children born
per year; mothers' stability of relationships with partners and
relationships with the biological father of the child; mothers' use of
welfare, food stamps, and Medicaid; mothers' use of substances; mothers'
arrests and incarcerations; and children's academic achievement, school
conduct, and mental disorders. Secondary outcomes were the sequelae of
subsequent pregnancies, women's employment, experience of domestic
violence, and children's mortality. 
The authors found that 
v	Nurse-visited women had longer intervals between births of first
and second children, fewer cumulative subsequent births per year, and
longer relationships with current partners. 
v	From birth through child age 9, nurse-visited women used welfare
and food stamps for fewer months. 
v	Nurse-visited children born to mothers with low psychological
resources, compared with control-group counterparts, had better
grade-point averages and achievement test scores in math and reading in
grades 1 through 3. 
v	Nurse-visited children, as a trend, were less likely to die from
birth through age 9, an effect accounted for by deaths that were
attributable to potentially preventable causes. 
The authors conclude that by child age 9, the home visiting program
reduced women's rates of subsequent births, increased the intervals
between the births of first and second children, increased the stability
of their relationships with partners, facilitated children's academic
adjustment to elementary school, and seems to have reduced childhood
mortality from preventable causes.
NB Bravo Dr Olds and all the RNs who made this intervention succeed!!!
We are not surprised how wonderful the effect is.





Edisen RJ et al. Adverse Birth Outcome Among Mothers With Low Serum
Cholesterol PEDIATRICS Vol. 120 No. 4 October 2007, pp. 723-733
The authors set out was to assess whether low maternal serum
cholesterol during pregnancy is associated with preterm delivery,
impaired fetal growth, or congenital anomalies in women without
identified major risk factors for adverse pregnancy outcome. 
They studied mother-infant pairs from among a cohort of 9938 women who
were referred to South Carolina prenatal clinics for routine
second-trimester serum screening. Banked sera were assayed for total
cholesterol; <10th percentile of assayed values (159 mg/dL at mean
gestational age of 17.6 weeks) defined a "low total cholesterol"
prenatal risk category. Eligible women were aged 21 to 34 years and
nonsmoking and did not have diabetes; neonates were liveborn after
singleton gestations. Total cholesterol values of eligible mothers were
adjusted for gestational age at screening before risk group assignment.
The study population included 118 women with low total cholesterol and
940 women with higher total cholesterol. Primary analyses used
multivariate regression models to compare rates of preterm delivery,
fetal growth parameters, and congenital anomalies between women with low
total cholesterol and control subjects with mid-total cholesterol values
>10th percentile but <90th percentile. 
The authors found that the prevalence of preterm delivery among mothers
with low total cholesterol was 12.7%, compared with 5.0% among control
subjects with mid-total cholesterol. The association of low maternal
serum cholesterol with preterm birth was observed only among white
mothers. Term infants of mothers with low total cholesterol weighed on
average 150 g less than those who were born to control mothers. A trend
of increased microcephaly risk among neonates of mothers with low total
cholesterol was found. Low maternal serum cholesterol was unassociated
with risk for congenital anomalies. 
The authors conclude that total serum cholesterol <10th population
percentile was strongly associated with preterm delivery among otherwise
low-risk white mothers in this pilot study population. Term infants of
mothers with low total cholesterol weighed less than control infants
among both racial groups. 

NB Seems to me that cholesterol normally increases in pregnancy so a
low level might not be healthy?

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The National Fetal and Infant Mortality Review Program is a partnership
between ACOG and federal MCHB.

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