WHO Drug Information Vol. 20, No. 4, 2006 - World Health ...

WHO Drug Information Vol 20, No. 4, 2006
Regulatory Action and News
Bevacizumab approved
for lung cancer
United States of America — The Food
and Drug Administration (FDA) has
approved use of bevacizumab (Avastin®)
in combination with carboplatin and
paclitaxel for initial systemic treatment of
patients with unresectable, locally advanced,
recurrent or metastatic, nonsquamous,
non-small cell lung cancer.
Approval was based on an improvement
in survival time when bevacizumab was
added to a standard chemotherapy
regimen. Lung cancer is the leading
cause of cancer-related death in men and
women.
The most serious adverse events associated
with bevacizumab, including some
fatal cases, were gastrointestinal perforation,
wound healing complications,
haemorrhage, blockage of arteries,
abnormally high blood pressure, albumin
deficiency in blood and congestive heart
failure. The most common adverse
events included weakness, abdominal
pain, headache, diarrhoea, nausea and
vomiting.
Bevacizumab, in combination with intravenous
5-fluorouracil-based chemotherapy,
was previously approved for firstor
second-line treatment of patients with
metastatic cancer of the colon or rectum.
Reference: FDA News, P06-166. 12 October
2006
Risperidone for irritability
associated with autism
United States of America — The Food
and Drug Administration (FDA) has
approved risperidone (Risperdal®) orally
disintegrating tablets, an adult antipsy-
chotic drug, for the symptomatic treatment
of irritability in autistic children and
adolescents. The approval is the first for
the use of a drug to treat behaviours
associated with autism in children. These
behaviours are included under the general
heading of irritability, and include
aggression, deliberate self-injury, and
temper tantrums.
Risperdal® has been approved since
1993 for the short-term treatment of
adults with schizophrenia, and since 2003
for the short-term treatment of adults with
acute manic or mixed episodes associated
with extreme mood swings. The
most common side effects of the use of
risperidone included drowsiness, constipation,
fatigue and weight gain.
Reference: FDA News, P06-163. 6 October
2006.
New treatment
for chronic hepatitis B
United States of America — The Food
and Drug Administration (FDA) has
approved telbivudine (Tyzeka®) for the
treatment of adults with chronic hepatitis
B (HBV), a serious viral infection that can
cause lifelong infection, scarring of the
liver (cirrhosis), and eventually liver
cancer, liver failure, and death.
Telbivudine is not a cure for hepatitis B,
and long-term treatment benefits of this
drug are not known. Use of telbivudine
has not been shown to reduce the risk of
transmission of HBV to others through
sexual contact or blood contamination.
The most common side effects were
elevated creatinine phosphokinase, upper
respiratory tract infection, fatigue, headache,
abdominal pain and cough. Also,
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