[Posted 09/19/2012] ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with pramipexole (Mirapex). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether pramipexole increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with pramipexole and will update the public when more information is available.
FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with pramipexole than with placebo; however, these results were not statistically significant. FDA also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with pramipexole use. However, study limitations make it difficult to determine whether excess heart failure was related to pramipexole use or other influencing factors (see FDA Drug Safety Communication Data Summary for a detailed discussion of the studies).
BACKGROUND: Pramipexole is a prescription medicine used to treat the signs and symptoms of Parkinson's disease and moderate to severe symptoms of primary restless legs syndrome, in a class of medicines called dopamine agonists.
RECOMMENDATION: At this time, FDA has not concluded that pramipexole increases the risk of heart failure. Healthcare professionals should continue to follow the recommendations in the drug label when prescribing pramipexole. Patients should continue to take their pramipexole as directed and should contact their health care professional if they have any questions or concerns. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Pramipexole is used alone or with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Pramipexole is also used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Pramipexole is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance in the brain that is needed to control movement.
Pramipexole comes as a tablet to take by mouth. When pramiprexole is used to treat Parkinson's disease, it is usually taken three times a day. When pramiprexole is used to treat restless legs syndrome, it is usually taken once a day, 2 to 3 hours before bedtime. Pramipexole may be taken with or without food, but taking pramipexole with food may help to prevent nausea that may be caused by the medication. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take pramipexole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will start you on a low dose of pramipexole and gradually increase your dose. Your doctor will probably not increase your dose more often than once every 4 to 7 days. It may take several weeks before you reach a dose that works for you.
If you are taking pramipexole to treat restless legs syndrome, you should know that as your treatment continues, your symptoms may worsen, may begin earlier in the evening or afternoon, or may occur in the early morning. Call your doctor if your symptoms worsen or if they begin to occur at different times than in the past.
Pramipexole controls the symptoms of Parkinson's disease and restless legs syndrome but does not cure these conditions. Continue to take pramipexole even if you feel well. Do not stop taking pramipexole without talking to your doctor. If you are taking pramipexole to treat Parkinson's disease and you suddenly stop taking the medication, you may experience, fever, muscle stiffness, changes in consciousness, and other symptoms. Your doctor will probably decrease your dose gradually over 7 days.
If you stop taking pramipexole for any reason, do not start to take the medication again without talking to your doctor. Your doctor will probably want to increase your dose again gradually.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
If you are taking pramipexole to treat Parkinson's disease, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
If you are taking pramipexole to treat restless legs syndrome, skip the missed dose. Take your regular dose 2 to 3 hours before your next bedtime. Do not double the next dose to make up for the missed dose.
abnormal body movements and motions
difficulty falling asleep or staying asleep
difficulty remembering or thinking
abnormal thoughts or dreams
loss of appetite
frequent urination or urgent need to urinate
difficulty urinating or pain when urinating
decreased sexual interest or ability
swelling of the arms, hands, feet, ankles, or lower legs
hallucinations (seeing things or hearing voices that do not exist)
changes in vision
shortness of breath
dark, red, or cola-colored urine
muscle stiffness or aching
Some people who took medications such as pramipexole to treat Parkinson's disease or restless legs syndrome developed gambling problems, an increased interest in sex, or overeating problems. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you have difficulty controlling any of these behaviors. Tell your family members about these risks so that they can call the doctor even if you do not realize that your behavior has become a problem.
People who have Parkinson's disease may have a greater risk of developing melanoma (a type of skin cancer) than people who do not have Parkinson's disease. There is not enough information to tell whether medications used to treat Parkinson's disease such as pramipexole increase the risk of developing skin cancer. You should have regular skin examinations to check for melanoma while you are taking pramipexole even if you do not have Parkinson's disease. Talk to your doctor about the risk of taking pramipexole.
Pramipexole may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 09/19/2012
AHFS® Consumer Medication Information. © Copyright, 2013. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.