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August
2001
FDA
Issues Guidance on Levothyroxine Sodium, a Popular Thyroid Hormone
For decades, Levothyroxine sodium, the most popular thyroid hormone for
replacement therapy, had not been required to go through the Food and
Drug Administration's approval process. But in 1997, the FDA reclassified
all oral levothyroxine products as "new drugs," obligating the
manufacturers to meet approved New Drug Applications (NDAs) before August
14, 2001. A history of potency and stability problems with orally administered
levothyroxine sodium products resulted in the agency's decision.
Two levothyroxine sodium products, Unithroid and Levoxyl, have recently
been approved by the FDA to treat hypothyroidism. And now the FDA is issuing
guidance regarding the transition of patients from unapproved to these
approved products, and the handling of those products being marketed without
an approved application. The FDA will gradually do away with the unapproved
products to allow manufacturers of approved products to expand to meet
demand and to give patients and health care providers enough time for
a clean transition.
Two of the most common formulations that are being phased out are Synthroid
and Levothroid. Manufacturers of unapproved oral levothyroxine sodium
drug products without an NDA pending with the FDA must cease distribution
by August 14, 2001.
August
2001 Update
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The
Benefits of Surgery for Ear Infection are Unclear
Every year thousands of young children undergo surgery to alleviate
chronic middle ear infections (otitis media). The demand for these
procedures is driven by the concern that persistent bouts of ear infection
will cause hearing loss and long-term effects on their child's speech
and language development. However, the benefits of surgery are unclear
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even after two recent new studies.
The most common operation involves inserting tubes through the eardrums
to drain fluid that collects in the middle ear. Whether or not prompt
implementation of this surgery actually protects against the development
of infection was the subject of the first study in which 6,350 children
were checked regularly for ear infections. By the age of 3, 429 of them
were diagnosed with chronic ear infections. About half received the surgery
as soon as possible, while the others waited up to nine months. The researchers
found the children who had the surgery promptly had fewer subsequent ear
problems than those who waited. But there was no significant difference
in their speech, language, cognition or psychosocial development as measured
by standardized tests and parental assessments. In fact the mean scores
for all of the children fell with the average range for that age.
The second study examined hospital discharge records for children in Ontario
to determine whether removing adenoids and/or tonsils at the same time
as the insertion of tubes helped reduce the likelihood of subsequent ear
problems. Of the 37,316 cases who received tubes, 28% also involved the
removal of adenoids and/or tonsils. About one quarter of those who didn't
undergo adjuvant surgery were re- hospitalized within two years after
their initial surgery for subsequent ear problems. But those who did nearly
halved their risk of re-hospitalization. Having both adenoids and tonsils
out provided additional benefit.
So should children with chronic ear infections have tubes inserted, and
should they also have their adenoids and tonsils taken out? Because of
limitations in these and previous studies, we still don't know. More research
is needed to weigh the long-term risks of hypothetical development impairment
verses the not fully understood risk of the different surgeries.
August
2001 Update
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Take
Low-Dose Aspirin and Skip Vitamin E to Prevent Cardiovascular Disease
For more than 100 years aspirin has helped relieve headaches and other
pain, and now new evidence from the Primary Prevention Project backs the
claim it also helps prevent heart attacks and other cardiovascular events.
The same study also found the antioxidant vitamin E didn't help.
The theory that anti-platelet/anti-inflammatory drugs like aspirin and
antioxidant nutrients like vitamin E might interfere with atherosclerosis
and prevent cardiovascular disease is not new. But previous research on
both possibilities has come up with mixed results. In an attempt to resolve
the debates, Italian researchers randomized 4,495 people (2583 females
and 1912 men) with an average age of 64.4 to receive low-dose aspirin
(100mg/day) or no aspirin and vitamin E supplements (300mg/day) or no
vitamin E. They limited their investigation to people over 50 with one
or more of the major cardiovascular risk factors: hypertension, high blood
cholesterol, diabetes, obesity, family history of early heart attacks
or individuals who were elderly.
Aspirin proved to be beneficial with respect to all of the criteria measured.
It reduced the risk of a cardiovascular death by 44% and the risk of cardiovascular
events or disease by 23%. However, severe gastrointestinal bleeding was
more frequent in the aspirin group than in the non-aspirin group (1.1%
vs 0.3%). Consistent with the negative results of other large published
trials, vitamin E provided no significant improvements in any of the criteria.
The study was stopped prematurely after a mean follow-up of 3.6 years
because evidence from two other studies involving a total of 24,289 patients
concurred that aspirin is beneficial in primary prevention.
August
2001 Update
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Insomnia
and Alcohol Dependence: A Dangerous Duo?
An alcoholic's sleep patterns prior to attempted recovery may
indicate the risk of relapse, according to a study recently published
in the American Journal of Psychiatry.
The study, conducted at the University of Michigan Medical School, suggests
that alcoholics who experience insomnia prior to abstinence are more likely
to relapse than alcoholics without chronic sleep problems. Although not
conclusive, the study found insomnia was "significantly associated"
with the severity of alcohol dependency and depression in the patients
observed.
All told, 172 patients, who averaged 32 days of abstinence, were observed
and 74 of them were followed up for an average of five months. Thirty
percent of patients followed who did not have insomnia relapsed. The percentage
for patients with insomnia was twice that, but remarkably a history of
self-medicating with alcohol to relieve insomnia didn't appear to figure
into the relapse rate.
A qualifying factor is that most patients who were studied upon entering
treatment reported having previous symptoms of insomnia. Moreover, health
professionals generally accept that poor sleep — not necessarily
clinical insomnia — can go hand in hand with alcoholism, and may
intensify during withdrawal. But patients in the study screened for the
symptoms that qualify them as insomniacs before treatment remained at
greater risk for relapse.
A significant problem addressed by the study was the penchant of recovering
alcoholics to use alcohol as a sedative, enabling them to sleep. This
strategy is self-defeating. It may work at first, but as tolerance to
alcohol builds, so does its ability to impair sleep, and dependence grows.
August
2001 Update
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