WARNING Taking hepatitis B drug with interferon potentially dangerous: Health Canada

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> Taking hepatitis B drug with interferon potentially dangerous: Health Canada>

> By The Canadian Press> >

http://ca.news./s/capress/080312/health/health_hepatitis_drug_warning_1\

> > OTTAWA - Health Canada is warning consumers being treated with Sebivo > for

hepatitis B not to combine the medication with any interferon > products because

of potentially serious drug interactions.> > Taking both Sebivo (telbivudine)

and interferon may increase the risk > of peripheral neuropathy, a condition

marked by weakness, numbness, > tingling and burning sensations in the arms

and-or legs.> > The anti-viral agent is authorized by Health Canada for use

alone, > not in combination with any interferon products, including standard >

or pegylated types of interferon alfa (marketed under brand names > such as

Pegasys, Pegatron, Intron A, Unitron Peg, Rebetron, Roferon > A, and Infergen)

and of interferon beta, (marketed under brand names > such as Rebif, Betaseron

and Avonex).> > The drug's maker, Novartis Pharmaceuticals Canada Inc., said

that in > a small clinical trial testing the use of both Sebivo and the >

interferon product Pegasys (peginterferon alfa-2a), serious > peripheral

neuropathy occurred in five out of 48 patients (10 per > cent), and was

occasionally disabling. The condition usually started > about three months after

treatment began.> > Health Canada said Wednesday it is not yet known if this

adverse > event is reversible once treatment is stopped, or whether it might >

also occur when the drug is used with interferon products other than Pegasys.> >

Consumers are advised to tell their doctors if they are taking Sebivo > and an

interferon product, but should not discontinue or modify > Sebivo without first

consulting their physician, due to the risk of > worsening the hepatitis B

infection.> > Peripheral neuropathy has been reported in five out of 2,000

patients > (less than one per cent) using telbivudine alone in clinical trials.

> The disorder also is a common adverse reaction of Pegasys (reported > on

average in one to five out of 100 patients in clinical trials).> > The risk of

developing peripheral neuropathy is increased when a > patient receives

telbivudine in combination with Pegasys, compared to > either treatment alone,

Health Canada said.> > Consumer information for telbivudine is being updated and

Novartis > has issued a letter to health professionals advising them of the new

> safety information.

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