GlaxoSmithKline (GSK) asserts it has been fully forthcoming regarding its drug abacavir (found in Ziagen, Epzicom and Trizivir) and a possible link to heart attacks, according to a letter GSK sent late last week to The Independent. The letter refutes an article published on May 12 suggesting that the company neglected to publicly disclose a Swedish report filed with the company in 2005—three years before the international Data Collection on Adverse Events on Anti-HIV Drugs (D:A:D) study documented a 90 percent increased risk of heart attack among patients taking abacavir.
When the D:A:D study results initially became public—first at the 15th Conference on Retroviruses and Opportunistic Infections in February in Boston, and then in an April issue of The Lancet—GSK responded by saying that an analysis of their studies on abacavir turned up no sign of an increased risk of a heart attack. The Independent, however, said that GSK failed at that time to mention that physicians in Uppsala, Sweden, sent GSK a warning letter in May 2005 detailing 34 cases of heart attacks in their patients taking the nucleoside reverse transcriptase inhibitor.
In their letter, GSK asserts that they cooperated fully with the Food and Drug Administration (FDA) at the time of the 2005 report and that extensive analysis of multiple databases satisfied both GSK and the FDA that there was no added heart attack risk in people taking abacavir.
NEW! Scroll down to comment on this story.
Please click OK to confirm your comment and confirm you accept our posting rules. Note your message will be reviewed by our staff before going live.
Previous Comments:
comments 1 - 2 (of 2 total)
Mike, Ridgeland, MS, 2008-05-21 15:58:56
Steve ... thanks for the follow through ... I'm on Epzicom and previous family history as well as my own Cholesterol increase has me concerned as well. I'll be checking a bit further, but as I've discovered in the past, some of these studies and results are skewed.
Steve, , 2008-05-21 11:58:06
I've been taking Trizivir for 5 years now, so was quite concerned about this. But it is VERY important to read further to put studies like this in perspective. After reading the D_A_D study results, this 90% increase is based on the ORIGINAL possibility of an hiv+ person (considering all other risk factors), possibly having a heart attack of 2%, and the 90% increase in THIS study changes THAT risk to 3.8%, which is quite a difference! Knowledge (and further research on one's own) is power.
"I'm HIV positive and diabetic (as well as have high cholesterol) and some of my meds specify taking them with 'high fat foods' which I have to do twice a day. I've eaten as healthy as possible, but when it comes to high fat foods, I am in a quandary...about what to eat sometimes..."
