Is Permax Safe ?

FDA Public Health Advisory
Pergolide (marketed as Permax)

The FDA has posted notification 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.

Permax is used for:

Treating Parkinson disease when used with levodopa/carbidopa.

Permax is dopamine agonist. It works by stimulating dopamine receptors in the brain.

Do NOT use Permax if:

• you are allergic to any ingredient in Permax
• you are allergic to ergot-type medicines (eg, ergotamine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Permax :

Some medical conditions may interact with Permax . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart or kidney problems, irregular heartbeat, lung problems, low blood pressure, or hallucinations

Some MEDICINES MAY INTERACT with Permax . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Butyrophenones (eg, haloperidol), metoclopramide, phenothiazines (eg, thioridazine), or thioxanthenes (eg, thiothixene) because the effectiveness of Permax may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Permax may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Permax may cause drowsiness, dizziness, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Permax . Using Permax alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Permax may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Permax . Permax will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Neuroleptic malignant syndrome (NMS) is a potentially deadly syndrome associated with Permax if you suddenly stop taking it or if your dose is lowered too quickly. Symptoms may include increased body heat; rigid muscles; altered mental abilities, including lack of response to your surroundings; fast or irregular heartbeat; sweating. Contact your doctor at once if any of these symptoms occur. Do not stop taking Permax without first talking with your doctor.
• Use Permax with caution in the ELDERLY because they may be more sensitive to its effects, especially confusion.
• Permax is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is unknown if Permax can cause harm to the fetus. If you become pregnant while taking Permax , discuss with your doctor the benefits and risks of using Permax during pregnancy. It is unknown if Permax is excreted in breast milk. Do not breast-feed while taking Permax .

If you suddenly stop taking Permax , you may experience WITHDRAWAL symptoms, including anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, lightheadedness, or seizures.

Possible side effects of Permax :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; diarrhea; difficulty sleeping; dizziness; drowsiness; dry mouth; lightheadedness; loss of appetite; nausea; pain; runny nose; stomach pain; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; increased jerking movements; leg or foot swelling; seeing or hearing strange things (hallucinations); severe dizziness or lightheadedness; trouble breathing; unusual weakness; unusually slow, fast, or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088).

General information:

• If you have any questions about Permax , please talk with your doctor, pharmacist, or other health care provider.
• Permax is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Permax . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.