FDA issues safety alerts for tipranavir and telithromycin
Safety alerts for tipranavir (Aptivus) and
telithromycin (Ketek) have been issued by the
US Food and Drug Administration.
An addition has been made to tipranavir’s
Black Box Warning regarding reports of both
fatal and non-fatal intracranial haemorrhage.
Boehringer Ingelheim identified 14 reports
of intracranial haemorrhage events, including
eight fatalities, in 6,840 HIV-1 infected individuals
receiving Aptivus capsules in combination
with antiretroviral therapy in clinical
trials. In many of the reported cases of intracranial
haemorrhage patients had other
medical conditions or were receiving concomitant
medicines, including anticoagulants
and antiplatelet agents, that may have caused
or contributed to these events.
Boehringer Ingelheim is currently in discussions
with the European Medicines Agency
(EMEA) about whether a similar warning will
be issued for tipranavir in Europe.
The FDA has also completed its safety assessment
of telithromycin, which has been associated
with rare cases of serious liver injury
and liver failure, including four reported
deaths and one liver transplant.The FDA says
that additional warnings are required and the
manufacturer is revising the drug labelling to
address this safety concern.The FDA is advising
both patients taking telithromycin and
their doctors to be on the alert for signs and
symptoms of liver problems. Patients experiencing
such signs or symptoms should discontinue
Ketek and seek medical assessment,
which may include tests for liver function, it
says.
The EMEA is currently undertaking a full
risk/benefit assessment of telithromycin following
a preliminary review earlier this year
(PJ, 4 February, p124) which led the agency
to ask for warnings concerning liver disorders
to be strengthened in product information. |
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Pharmaceutical Journal
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