The Food and Drug Administration recently cautioned that it is investigating the possibility that the combination Parkinson’s drug Stalevo® may increase the risk of heart attack, stroke, and death in elderly patients who are taking it.
Stalevo Heart Attack Risk
August 25, 2010 – This month, the FDA cautioned that it is investigating the possibility that the combination Parkinson’s drug Stalevo may increase the risk of heart attack, stroke, and death in elderly patients who are taking it. The agency urged patients not to stop taking the drug but warned them to let their physicians know if the patients have risk factors for cardiovascular disease.
Stalevo STRIDE-PD Study
The first indication of heart attack risk for Stalevo, the agency said, came from a clinical trial called STRIDE-PD, in which 373 patients took Stalevo and 372 received carbidopa/levodopa. The average age of the patients was 60, and the trial lasted an average of 2.7 years. The study found seven heart attacks and one death in the Stalevo group and none in the carbidopa/levodopa group. STRIDE-PD study findings appeared to indicate that the addition of Stalevo leads to an increased risk of all types of “cardiovascular events” such as stroke and heart attack.
Precautions Before Taking Stalevo
- Consult your doctor before beginning treatment with Stalevo if you are pregnant, planning to become pregnant, or breastfeeding. If you become pregnant while taking Stalevo, call your doctor.
- Stalevo may change the color of your sweat, saliva, or urine to a dark red, brown, or black color. While these effects are no cause for concern, they may stain your clothing.
- Consult your doctor about the risks of developing leukemia, bladder cancer, or other cancers after the end of your Stalevo treatment.
- Use extra caution when getting up from a sitting or lying position throughout your Stalevo treatment, especially at the beginning.
- Stalevo may cause nausea, especially at the beginning of treatment.