Portugal Travel

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February 13, 2009

INFARMED recorded 21 cases of adverse reactions to the vaccine Gardasil, but will not stop drug

The chairman of the authority of medicine (INFARMED) admitted Friday it had registered 21 cases of adverse reactions to Gardasil vaccine against the human papilloma virus, but rejected the need to suspend the drug in Portugal, writes the Lusa.

The Spanish authorities have temporarily suspended a consignment of medicine this week, after the known cases of adverse effects, but the INFARMED confirmed that no dose of this lot into Portugal.

21 cases recorded
The chairman of the National Authority of Medicines and Health Products (INFARMED), Maria Vasco, confirmed this to journalists Friday the notification of 21 cases of adverse reactions to date, 14 of them considered serious.

In none of these cases considered serious, which had seizures (one case) or feeling faint, there was need of hospitalization, he stressed, adding that young women vaccinated recovered quickly.

Drug or injection?

"It is difficult to know whether the situation is due to the drug or the injection", said, adding that any vaccine involves risks and that in the case of this product the 'benefit is greater than the risk'.

Vasco Maria also said that the cases reported by health professionals took place immediately after the injection and that the young spontaneously recovered, and no complication.

All reactions with

"There is no medicine that has no reports of adverse reactions", he added, stressing that the situation is being investigated by the European Medicines Agency.

They have recommended that the vaccine will include a leaflet in the occurrence of fainting or seizures as possible side effects, which were not yet described, he added.

The vaccine Gardasil, active against four sub-types of the virus that is considered the most likely cause of cervical cancer, began to be marketed in Canada for about two years and was recently included in the National Immunization Plan.

Last year the vaccine in Portugal included the young born in 1995. This year they can receive the vaccine for girls born in 1996 and 2010 will be those who were vaccinated in 1997. Between 2009 and 2011 is still expected to have the vaccine 17 years.