Answers 12/30/1994 FDA APPROVES NEW DIABETES DRUG

T94-64                                            Susan M. Cruzan
Dec. 30, 1994                                     301-443-3285

                 FDA APPROVES NEW DIABETES DRUG

     We have been receiving inquiries about the approval of
metformin, a new drug for treatment of adult onset non-insulin
dependent, or type II, diabetes, a serious disorder of blood
sugar control.  Type II diabetes afflicts 12 million Americans
and can cause damage to the eyes, kidneys, heart and peripheral
circulation.  The following may be useful in answering questions. 
     Patients with type II diabetes are generally advised to lose
weight and maintain a strict diet.  If these measures fail to
control blood sugar levels, they are generally prescribed oral
drugs and, if these fail, insulin injections.  
     Metformin is an oral medication for controlling elevated
blood sugar levels in type II diabetes.  It differs from other
currently approved antidiabetic drugs chemically and in how it
works.  It can be used together with currently available 
oral antidiabetic drugs.  
     In March 1994, an FDA advisory committee voted unanimously
to recommend that FDA approve metformin for people with diabetes
who cannot achieve adequate blood sugar control with diet alone. 
At this meeting the president of the American Diabetes
Association urged approval of metformin as a safe and effective
drug that controls blood glucose by mechanisms different from
currently available drugs.  
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                                      Page 2, T94-64, Metformin
    In people with diabetes, the pancreas does not produce enough
insulin to control blood sugar, which then rises to harmful
levels.  Metformin and other oral anti-diabetic drugs lower these
elevated blood sugar levels.  Currently approved and marketed
anti-diabetic drugs work by stimulating the pancreas to secrete
more insulin.  Metformin increases the body's response to its own
insulin.  Unlike the other drugs, metformin rarely causes
hypoglycemia and generally does not cause weight gain.  It may
cause temporary anorexia (loss of appetite), abdominal discomfort
or nausea.
     One concern with oral antidiabetic drugs -- including
metformin -- is the potential risk of cardiovascular death.  A
warning to this effect is contained in the labeling for these
drugs.  Studies are under way to gain more information about this
and other complications.
     Safety concerns about a related drug -- phenformin --
resulted in its being removed from the market in 1977. 
Phenformin was found to promote the development of lactic
acidosis, a life-threatening buildup of lactic acid in the blood
that was fatal in about one patient in one thousand treated for a
year.  Numerous studies with metformin and marketing experience
in other countries have shown that, although it can cause lactic
acidosis, the risk is much less than that of phenformin.
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                                       Page 3, T94-64, Metformin 
     Patients given metformin should be made aware of lactic
acidosis symptoms -- malaise, rapid breathing, shortness of
breath and severe weakness  -- and be advised to contact their
doctors immediately if they experience any of these.  Lactic
acidosis can be diagnosed with laboratory tests and requires that
metformin therapy be stopped immediately and proper supportive
care initiated. 
     During worldwide marketing, patients on metformin have
developed lactic acidosis at about one tenth the rate of those on
phenformin.   Metformin has been approved in about 80 countries
and has never been withdrawn for safety reasons.  The
manufacturer, Lipha Pharmaceuticals Co. of New York, N.Y.,
submitted an application for marketing to FDA in September l993.  
      A patient package insert will be included with metformin. 
Lipha will conduct an educational campaign to inform health
professionals and patients about the drug's risks and benefits
and appropriate precautions.  The company will also conduct a
postmarketing study in 10,000 patients to increase knowledge
about potential safety problems.
      Metformin will be sold under the trade name Glucophage.
The product will be distributed in the United States by Bristol-
Myers Squibb of Princeton, N.J. 
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