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November
2001
Pregnancy
and Anticonvulsant Drugs
"Do you have epilepsy or take any anticonvulsant drugs?" This
is a common question asked of pregnant women and women who are planning
to become pregnant. The cause for the concern is the risk of birth defects
associated with the disease. But whether birth defects are related to
the mother's epilepsy or caused by the drugs used to treat it remained
unknown until recently.
A study published in the New England Journal of Medicine examined
newborns for birth defects related to anticonvulsant drugs. Each newborn
belonged to one of three groups: newborns exposed to anticonvulsant drugs
in the womb; newborns of mothers with epilepsy who did not take anticonvulsant
drugs; and newborns of mothers without epilepsy or a history of seizures.
Results showed birth defects were more frequent in infants exposed to
anticonvulsant drugs (20% of infants exposed to one drug had birth defects
and 28% of infants exposed to two or more drugs had birth defects). However,
the infants of mothers with epilepsy who were not treated with anticonvulsant
drugs were at no greater risk of birth defects then infants of mothers
without epilepsy.
This study suggests birth defects are caused by anticonvulsant drugs
and not by epilepsy itself. A separate, earlier study based on data from
a number of different countries identified the types of birth defects
associated with common anticonvulsant drugs. Some of these findings are
summarized below:
| Birth
Defect |
Related
Anticonvulsant Drug |
| Spina bifida |
Valproic
acid |
| Oral clefts |
Phenobarbital
or methylphenobarbital |
| Heart defects |
Phenobarbital,
methylphenobarbital, valproic acid, or carbamazepine |
| Brain and
face abnormalities, shortened limbs |
Valproic
acid |
If you take anticonvulsant
drugs and are pregnant, or are thinking of becoming pregnant, consult
your physician about the risks to your baby.
November 2001 Update
Vaccine
safety: no link between thimerosal and neurodevelopmental disorders
Parents
should feel confident and safe when having their children immunized.
No evidence exists that proves a link between thimerosal-containing
vaccines and neurodevelopemental disorders, such as autism, attention
deficit-hyperactivity disorder, or speech and language delay.
The Institute of Medicine recently reported these findings, consistent
with the recommendations of the American Academy of Pediatrics.
Thimerosal, a mercury-containing preservative, was used for
many years in vaccines to prevent contamination. Taking in
a high dose of mercury is toxic to the human nervous system.
But because of the increasing number of vaccines routinely
recommended for infants, concern was raised in 1999 by the
Food and Drug Administration that the total amount of mercury
contained in the vaccinations could be exceeding the recommended
mercury levels for infants.
Although there's no data to suggest thimerosal caused any harm,
the American Academy of Pediatrics and the U.S. Public Health
Service have requested manufacturers remove thimerosal from
vaccines. As a result, most, if not all, childhood vaccines
are now thimerosal-free.
The Institute of Medicine's recommendations emphasized the
importance and continued safety of childhood vaccination. Parents
should definitely be reassured that all routine childhood immunizations
are in their children's best interests, as they clearly have
been shown to prevent potentially life-threatening diseases.
November 2001 Update
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Side
Effect Warning for New Rheumatoid Arthritis Drug, Remicade (Infliximab)
All drugs have side
effects, but some of them don't become apparent until after the
drugs have been approved and in use for some time.
Remicade (infliximab),
a powerful new drug for rheumatoid arthritis, has been found to worsen
congestive heart failure. The drug was actually being tested to see
if it would help patients with congestive heart failure. Instead, the
opposite was seen in a trial involving 150 people with moderate to
severe congestive heart failure. Of the 101 subjects treated with Remicade,
7 died. In contrast, no fatalities occurred in the 49 patients being
treated with the sugar pill placebo.
Some 2 million
Americans suffer from rheumatoid arthritis, while 5 million have congestive
heart failure. So an undetermined number must have both illnesses.
As a result, Centocor, the company making Remicade, after consultation
with the U.S. Food and Drug Administration, has sent letters to doctors
urging that patients with both rheumatoid arthritis and congestive
heart failure not be treated with their drug.
November 2001 Update
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Normal
ECG May Not Mean Everything is Fine
An electrocardiogram (ECG) graphically records the electrical current
running through the heart muscle. By examining the graph, physicians
can detect injury to the heart, abnormal heart rhythms, thickening or
thinning of the heart muscle wall, and other conditions. Doctors use
an ECG —
along with a physical exam and blood tests for heart muscle enzymes —
to diagnose a suspected heart attack. ECGs that clearly indicate a heart
attack are known as diagnostic ECGs. But in some cases, patients
who are having a heart attack may have a normal or nonspecific
ECG. Doctors had assumed heart attack patients with normal or nonspecific
ECGs would have a better short-term survival rate than heart attack patients
with diagnostic ECGs. And that is, in fact, the case. But a new study
in the Journal of the American Medical Association shows the absolute
number of heart attack patients with normal or nonspecific ECGs who die
during hospitalization is much higher than expected.
The study authors analyzed data, collected by the National Registry of
Myocardial Infarction (NRMI) between June 1994 and June 2000, on 391,208
patients who had been hospitalized for a heart attack. As expected, heart
attack patients with a normal ECG were 41% less likely to die in the
hospital than heart attack patients with a diagnostic ECG, and patients
with a nonspecific ECG were 30% less likely to die. Surprisingly, however,
5.7% of heart attack patients with a normal ECG and 8.7% with a nonspecific
ECG did die in the hospital.
The researchers noted heart attack patients with normal ECGs are less
likely to be treated with aspirin and heparin, blood-thinners that help
prevent new blood clots, or with beta-blockers, which slow the heart
rate and prevent abnormal heart rhythms. Though the study did not investigate
whether aggressive post-heart attack treatment would lower the mortality
rate in this group, it does open up the question for further research.
The exceptions in this study - who had normal ECGs and low mortality
rates - were men younger than 65 years and patients with an ejection
fraction of 40% or greater. An ejection fraction measures how much blood
the heart empties when it contracts, relative to the volume of blood
in the heart when it expands.
November 2001 Update
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A
New Acute Hepatitis C Treatment
A newly-tested treatment for acute hepatitis C virus (HCV) may prevent
the infection from developing into the chronic stage. The virus is
the leading cause of liver disease in the United States.
Researchers in Germany found acute HCV did not progress in 98 percent
of infected study subjects who received interferon alfa-2b treatment,
an antiviral protein. Their results also suggest the treatment is more
effective, less expensive, and leads to fewer side effects than other
known therapies. The study will be appearing in the New England
Journal of Medicine's November 15, 2001, issue.
During the first four weeks of the study, patients were injected with
5 million U of the drug daily, followed by 5 million U three times
a week for the next 20 weeks. It took 3.2 weeks, on average, for levels
of HCV to become undetectable in patients, and all 44 patients reached
the undetectable mark at some point during therapy. After an additional
24 weeks of follow up, 42 of the 43 patients who completed the study
still were still infection free.
The researchers suggest 24 weeks of therapy for patients in the early
part of the acute stage (fewer in patients whose serum levels of HCV
quickly become undetectable), and 48 weeks of therapy for patients
with chronic HCV. Though no serious side effects were noted, one person
dropped out because of hair loss and flu-like symptoms.
There is no standard treatment for acute HCV, and progression from
acute to chronic occurs in 50%–84% of cases. Chronic HCV infects
almost 4 million people in the United States and about 170 million
people worldwide. Cirrhosis of the liver develops in 10–30 percent
of those people.
November 2001 Update
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