ROCKVILLE, Md., Dec. 18 /PRNewswire/ -- FDA has approved abacavir (trade
name Ziagen) for the treatment of Human Immunodeficiency Virus-1 (HIV-1) in
adults and children. The following can be used to answer questions:
Ziagen, an oral medication taken twice daily, is one of a class of
medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs)
and is taken in combination with other anti-HIV medications. This combination
of medicines helps to lower the amount of HIV found in the blood.
This new drug offers another choice for the treatment of HIV, a virus that
mutates quickly and may become resistant to current treatment. Ziagen,
available in tablet and liquid form is approved for adults and pediatric
patients older than three months of age.
A potentially fatal hypersensitivity, or allergic reaction, has been
associated with the use of Ziagen in at least 5 percent of patients. Symptoms
of this reaction may include skin rash, fever, nausea, abdominal pain and
severe tiredness.
A written list of the hypersensitivity symptoms is printed on a warning
card and is provided along with a Medication Guide to patients by pharmacists.
Anyone who experiences a hypersensitivity reaction must stop taking the
medicine and call their health care provider immediately. Ziagen should not be
taken again after a reaction occurs because more severe symptoms will arise
within hours and may include life-threatening low blood pressure or death.
An abacavir hypersensitivity reaction registry has been established --
physicians should register patients developing symptoms of hypersensitivity by
calling 1-800-270-0425.
All NRTIs can cause lactic acidosis-- a fatal metabolic disturbance that
causes an abnormal buildup of lactic acid-- symptoms may include an enlarged
liver.
Additional reported side effects of abacavir include nausea, vomiting,
fatigue, headache, diarrhea, and loss of appetite.
Accelerated approval of Ziagen was based on analyses of surrogate markers
in three controlled studies of up to 24 weeks in duration. At present there
are no results from controlled trials with Ziagen evaluating long-term
suppression of HIV infection or AIDS.
Ziagen is manufactured and marketed by GlaxoWellcome Inc. Of Research
Triangle Park, N.C.
Consumer Inquiries: 888-INFO-FDA
SOURCE Food and Drug Administration
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Related links:
http://www.fda.gov
CONTACT:
FDA, Print Media, 301-827-6242 or Broadcast
Media, 301-827-3434
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