The FDA has announced that Hismanal is associated with risks of death due to irregular heart rhythms when taken with certain other drugs and when used at higher than the recommended labeled dose. The new labeling also provides additional precautions against using Hismanal with a number of other drugs. Additionally, the label now recommends that Hismanal should not be taken with grapefruit juice. These recommendations are based on the potential of these drugs and grapefruit juice to interfere with the body's handling and metabolism of Hismanal. The new labeling also emphasizes that patients with liver disorders should not take Hismanal.
All drugs have side effects which can result in the discontinuation of effective therapy.
The following describes an unusual adverse event, reported in the literature, in a special patient population. Overall percentage ranged from 5 to 64. The potential seriousness of the problem extends well beyond appearance. A number of people taking protease inhibitor drugs have developed diabetes, high blood sugar and high levels of lipids in their blood and there is a concern about the long-term possibility of increased risk of heart disease among people who use protease inhibitors. The problem of unusual fat accumulation is becoming more pronounced in part because more people have been treated for longer periods with the combination drug therapies.