U.S. Food and Drug Administration
FDA Consumer magazine
September-October 2001
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of Contents
There is an inaccuracy in the article, "New Drug and Device Approved to Manage Diabetes" (Updates, March-April 2001 FDA Consumer). Specifically, the statement "Prandin at recommended doses generally will have less effect on glucose control than sulfonylureas" is incorrect. The regulatory basis of approval for Prandin included demonstration of comparability of efficacy and safety for Prandin and sulfonylureas glyburide and glipizide.
Mary Ann McElligott,
Ph.D.
Senior director, regulatory affairs
Novo Nordisk Princeton, N.J.
Robert I. Misbin, M.D., a medical
officer in the FDA's division of
metabolic and endocrine drug products,
responds:
"Dr. McElligott is correct. When
used as initial therapy in previously
untreated patients with Type 2 diabetes,
Prandin caused reductions in glucose
and glycosylated hemoglobin levels
that are similar to what would be
expected from sulfonylureas. Glycosylated
hemoglobin, also known as hemoglobin
Alc (HbAlc), is an index of long-term
blood glucose concentration. Lower
levels of glucose and HbAlc are associated
with a reduced risk of developing
long-term complications from diabetes."
We've heard that the FDA will not allow restaurants to cook eggs sunny side up after Sept. 1. Is this true? Why is the FDA doing this?
Pam and Steve McFarlan
Burnsville, Minn.
Joseph A. Levitt, director of
the FDA's Center for Food Safety
and Applied Nutrition, replies:
"There has been some confusion recently
in the media over the egg regulation.
Some reports have said that the FDA
was prohibiting restaurants from
serving eggs "sunny side up." That's
simply not true. There clearly is
the element of consumer choice involved
here. There is no FDA requirement
that prevents a restaurant from serving
eggs in any way a consumer asks for
them. What we want to do is to provide
the information as to what steps
consumers can take to protect themselves.
Those who are most likely to be affected
by foodborne illnesses are the very
young, older people, those with compromised
immune systems, and pregnant women.
We think that consumers need to know
what they can do to minimize any
risk. Our new egg handling instructions
that will appear on consumer egg
cartons beginning this fall say it's
important to cook eggs thoroughly
and to keep them refrigerated."
Editor's note: For more on the FDA's food safety priorities, see "Food for Thought...."
I am concerned and confused after reading "Hepatitis C: An Update" in your magazine, July-August 2001 issue. Under the topic heading "Disease in Decline," I find it very interesting that out of 8,000 U.S. military records that were reviewed, 17 recruits tested HCV positive 45 years earlier. What does this statement mean exactly? HCV testing has only been available for slightly over the past 10 years, so how could 17 recruits have tested positive when there was no way of testing them for HCV?
Martha Warner
Los Angeles
Leonard Seeff, M.D., a hepatologist
at the National Institute of Diabetes
and Digestive and Kidney Diseases
and lead investigator on the 45-year
follow-up study of HCV infection
in military recruits, responds:
"Because of an outbreak of streptococcal
infection and rheumatic fever on
a military base between 1948 and
1956, blood was drawn from 8,568
recruits to test for the presence
of streptococcal antibodies. Thereafter,
the specimens were placed in a freezer,
where they remained for over 45 years.
The stored samples were tested for
the presence of HCV several years
after the assay for this virus became
available."
An article in the July-August 2001 issue of FDA Consumer suggests better labeling for ingredients in food products ("Food Allergies: When Food Becomes the Enemy"). However, two very important items were omitted from the eight foods listed. Corn and sulfites can both cause severe reactions to individuals who are sensitive to them. I, personally, have extreme reactions to sulfites in all their various forms and now need to carry a syringe of adrenaline (epinephrine) with me at all times to treat reactions. There are still many times when I have found sulfites listed in foods in which one would never have anticipated their presence. It is only through a sense of what one could almost call paranoia that I check labels. However, there have been numerous times when I have sensed a reaction building and yet did not see sulfites listed as an ingredient. For that matter, just this past week, I used a condiment that had previously not listed sulfiting agents and now does. It's rather frightening to know that what I thought was a "safe" food can change overnight to one that my ingesting could necessitate emergency medical care. I urge you to ensure that corn and sulfites are included in this new labeling initiative.
Rita B. Mako
Baltimore
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2001-AUG-27.