The FDA is notifying you that the companies that manufacture and distribute pergolide have agreed to withdraw this drug from the market due to the potential for heart valve damage.  Two new studies showed that patients with Parkinson’s disease who were treated with pergolide had an increased chance of serious damage to their heart valves when compared to patients who did not receive the drug.  Pergolide is a member of a class of drugs known as dopamine agonists and is used with levodopa and carbidopa to manage the signs and symptoms (tremors and slowness of movement) of Parkinson’s disease.

Patients with Parkinson’s disease who are taking pergolide should:

• Contact their healthcare professional to discuss alternate treatment options. 
• NOT stop taking Pergolide without consulting their healthcare professional, since stopping pergolide too quickly can be dangerous and several other effective treatments are available.

Why is this medication prescribed?

Pergolide is used with another medication to treat the symptoms of Parkinson's disease (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Pergolide 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.

How should this medicine be used?

Pergolide comes as a tablet to take by mouth. It is usually taken 3 times a day, but may be taken only once a day at first. To help you remember to take pergolide, take it around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pergolide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of pergolide and gradually increase your dose, not more than once every 3 days.

Pergolide controls Parkinson's disease but does not cure it. It may take some time before you feel the full benefit of pergolide. Continue to take pergolide even if you feel well. Do not stop taking pergolide without talking to your doctor. If you suddenly stop taking pergolide, you may experience hallucinations (seeing things or hearing voices that do not exist), confusion, fever, muscle stiffness, loss of consciousness, sweating, fast heartbeat, incontinence, and other symptoms. Your doctor will probably decrease your dose gradually.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking pergolide,

• tell your doctor and pharmacist if you are allergic to pergolide; other ergot alkaloids such as bromocriptine (Parlodel), cabergoline (Dostinex), dihydroergotamine (D.H.E., Migranal), ergonovine (Ergotrate), ergotamine (Cafergot, Ercaf, others), methylergonovine (Methergine), and methysergide (Sansert); or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants; antihistamines; diazepam (Valium); dicloxacillin (Dyanpen); furosemide (Lasix); medications for anxiety; medications for mental illness such as chlorpromazine (Thorazine), fluphenazine, haloperidol (Haldol), perphenazine, prochlorperazine (Compazine), thioridazine (Mellaril), thiothixene (Navane), and trifluoperazine (Stelazine); medications for nausea such as metoclopramide (Reglan) and promethazine (Phenergan); medications for seizures such as phenytoin (Dilantin); propranolol (Inderal); salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had a problem with a heart valve or any inflammation, scarring, or fluid in the area surrounding the heart or lungs. It is especially important to tell your doctor if you developed any of these conditions while you were taking another medication. Also tell your doctor if you have or have ever had low blood pressure; irregular heartbeat, any condition that causes you to be confused or hallucinate (see things or hear voices that do not exist), uncontrolled movements of any part of your body, especially your hands or face, a sleeping disorder, or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pergolide, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pergolide.
• you should know that pergolide may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that you may suddenly fall asleep during your regular daily activities while you are taking pergolide. You may not feel drowsy before you fall asleep. If you suddenly fall asleep while you are doing something such as eating, talking, or watching television, call your doctor. Do not drive a car or operate machinery until you talk to your doctor.
• remember that alcohol can add to the drowsiness caused by this medication.
• you should know that pergolide may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking pergolide. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

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 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.

What side effects can this medication cause?

Pergolide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• diarrhea
• stomach pain
• upset stomach
• vomiting
• indigestion
• loss of appetite
• weight gain
• difficulty falling asleep or staying asleep
• dry mouth
• nervousness
• confusion
• restlessness
• pain anywhere in your body, especially your back, joints, or neck
• flushing
• change in ability to taste food
• eye or vision problems such as double vision
• hiccups
• flu-like symptoms
• runny nose
• tight or floppy muscles

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• hallucinations (seeing things or hearing voices that do not exist)
• delusions (mistaken ideas about what is happening or who you are)
• difficulty moving
• chest pain
• fast or pounding heartbeat
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• large weight gain in a very short time period
• dizziness
• weakness
• shortness of breath
• rash

Like all medications, pergolide was studied in a limited number of patients before it was approved for sale to the public. Some patients who took pergolide during these studies died while they were taking the medication. Most of these patients were elderly, had many health problems, and had been taking pergolide for years. The patients died of a variety of causes and it seems likely that many of these patients would have died even if they had not taken pergolide. It is not known if pergolide contributed to these deaths. Talk to your doctor about the risks of taking pergolide.

Pergolide may cause other side effects. Call your doctor if you have any unusual problems while 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/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

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 emergency/overdose

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.

Symptoms of overdose may include:

• upset stomach
• vomiting
• blurred vision
• dizziness
• fainting
• pounding heartbeat
• angry or aggressive behavior
• hallucination (seeing things or hearing voices that do not exist)
• movements that you cannot control
• tingling in arms or legs
• seizures
• fast thinking and motion

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to pergolide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Permax®