Warning over HIV drug

THE PHARMACEUTICAL Services yesterday issued a European Medicines Agency (EMEA) warning over the possible increased risk of heart attacks with use of an HIV drug.

Abacavir is sold by GlaxoSmithKline under the brand name Ziagen, but it is also an ingredient in Kivexa and Trizivir.

“The EMEA has looked at data… which suggests an increased risk of heart attack associated with the use of abacavir-containing medicines,” the statement said.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded at its March 2008 meeting that the available data did not allow a definitive conclusion on the association between the use of abacavir and an increased risk of heart attacks, but further information was needed to determine the risk, the statement said.

The EMEA did not recommend any changes in the prescribing information at present, but was requesting information from ongoing epidemiological studies.

The study cited by the EMEA involved more than 33,000 patients in Europe, Australia and the United States. It was initiated in 1999, with the aim of assessing associations between the use of anti-HIV medicines and the risk of cardiovascular disease.

“Results from the study suggested that use of abacavir within the previous six months is associated with an increased risk of myocardial infarction,” the statement said.

But in a pooled analysis of 54 clinical trials sponsored by GlaxoSmithKline, no increased risk of myocardial infarction with the use of abacavir was observed. These studies included a total of almost 10,000 patients taking abacavir, the EMEA said.

“Patients should continue taking their medication and speak to their doctors if they have any concerns,” it added.

The Pharmaceutical Services, which said they were carefully monitoring the situation, urged Cypriot doctors to report any suspect or undesirable effects in their patients at Tel. 22-407179 or www.moh.gov.cy/phs.