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More
information on Avodart / Dutasteride / Avolve
On October 10 2002 the FDA approved Avodart, (
Dutasteride ) the first dual-acting 5 alpha-reductase
inhibitor for benign prostatic hyperplasia (BPH)
Dutasteride was approved by the Swedish regulatory
authority (MPA) on July 24th 2002. It will be marketed in
Sweden by the trade name AvolveŅ. The MPA agreed to act as the
Reference Member State for the Mutual Recognition procedure
within Europe and GSK plan to market the drug in all major
European markets once approvals are finalised during 2003. The
European trade name (Avolve) is to be confirmed.
Avodart ( Dutasteride ) is being released for the treatment
of the prostate.
It is not clear at the moment when Glaxo will proceed with
hair loss trials.
Avodart should be available in December 2002.
Side Effects
- Dutasteride should not be used in women and children.
Women who are pregnant or may become pregnant should not
handle dutasteride because of possibility of absorption of
dutasteride and subsequent potential risk to a male foetus.
- Men treated with dutasteride should not donate blood
until at least six months after their final dose to prevent
giving dutasteride to a pregnant woman through a blood
transfusion. Men with an allergic reaction to dutasteride or
its ingredients should not take it. Men with liver disease
should talk to their doctor before taking dutasteride.
- Clinical trials of dutasteride showed that it was
generally well tolerated. Most side effects were mild or
moderate and generally went away while on treatment in both
the dutasteride and placebo groups.
- Drug-related side effects during the first six months
were as follows: impotence (4.7 percent vs. 1.7 percent for
placebo), decreased libido (3 percent vs. 1.4 percent),
breast tenderness and breast enlargement (gynecomastia; 0.5
percent vs. 0.2 percent) and ejaculation disorders (1.4
percent vs. 0.5 percent).
- The incidence of most drug-related sexual adverse events
decreased with duration of treatment. The incidence of
drug-related breast tenderness and breast enlargement
remained constant over the treatment period. Ejaculate
volume may be decreased in some patients with continued
treatment. This decrease did not appear to interfere with
normal sexual function.
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