Link to Original MedWatch:http://bit.ly/2zcqAy9
AUDIENCE: Pharmacy, Neurology, Urology, Patient
ISSUE: FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines, Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa).
BACKGROUND: FDA alerted the public of a clinical trial in March 2010 suggesting a possible increased risk of prostate cancer with the entacapone component of Stalevo. FDA subsequently required the Stalevo manufacturer, Novartis, to conduct a study to further evaluate this potential risk. FDA also studied this issue independently using data from the Department of Veterans Affairs Health Care System. Based on these additional studies, FDA concluded that entacapone use is not associated with an increased risk of prostate cancer (see Data Summary, available at: http://bit.ly/2zcqAy9).
RECOMMENDATION: As a result, FDA' s recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the prescribing information.
Health Care Professionals: should follow standard prostate cancer screening recommendations for patients.
Patients: should continue to take their medicine as prescribed. Talk to your health care professionals if you 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.
Why is this medication prescribed?
Entacapone is an inhibitor of catechol-O-methyltransferase (COMT). It is used in combination with levodopa and carbidopa (Sinemet) to treat the end-of-dose 'wearing-off' symptoms of Parkinson's disease. Entacapone helps the levodopa and carbidopa work better by allowing more of it to reach the brain, where it has its effects.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Entacapone comes as a tablet to take by mouth. It is taken with every dose of levodopa and carbidopa, up to 8 times a day. Entacapone may be taken with or without food. Read your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take entacapone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Entacapone helps control the symptoms of Parkinson's disease, but it does not cure it. Continue to take entacapone even if you feel well. Do not stop taking entacapone without talking to your doctor. Stopping entacapone suddenly may make your Parkinson's disease worse and could have other dangerous effects. Your doctor probably will decrease your dose gradually if necessary.
What special precautions should I follow?
Before taking entacapone,
- tell your doctor and pharmacist if you are allergic to entacapone or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially ampicillin, apomorphine (Zydis), bitolterol (Tornalate), chloramphenicol (AK-Chlor, Chloromycetin), cholestyramine (Cholybar, Questran, Questran Light, others), medications that cause drowsiness (including medications for anxiety and sleeping pills), dobutamine (Dobutrex), epinephrine (AsthmaHaler, EpiPen Auto-Injector, Primatene Mist, others), erythromycin (E-Base, E.E.S., E-Mycin, others), isoetharine (Arm-a-Med Isoetharine, Beta-2, Bronkometer, others), isoproterenol (Dispos-a-Med Isoproterenol, Isuprel, Medihaler-Iso, others), methyldopa (Aldomet), phenelzine (Nardil), probenecid (Benemid), rifampin (Rifadin, Rimactane), tranylcypromine (Parnate), and vitamins and herbal products.
- tell your doctor if you have or have ever had liver disease or a history of alcoholism.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking entacapone, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking entacapone.
- you should know that this medication may make you drowsy. Do not drive a car or operate heavy machinery until you know how entacapone affects you.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.
What side effects can this medication cause?
Entacapone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- upset stomach
- movements you cannot control
- stomach pain
If you experience any of the following symptoms, call your doctor immediately:
- difficulty breathing
- high fever
- muscle stiffness
- weakness with or without a fever
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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
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).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What other information should I know?
Keep all appointments with your doctor and the laboratory. You may become dizzy when you get up after sitting or lying down, especially when you begin taking entacapone. To avoid this problem, make sure to get up slowly, especially if you have been sitting or lying down for a long time.
Entacapone may cause your urine to change to a brownish-orange color. This effect is common and is not harmful.
Do not let anyone else take your medicine. 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.
Brand names of combination products
- Stalevo® (containing Carbidopa, Entacapone, Levodopa)