[Posted 11/16/2014] ISSUE: FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases.
FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.
BACKGROUND: The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on November 16, 2014. FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.
RECOMMENDATION:Health care professionals should not change the way they prescribe these drugs at this time. Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Prasugrel may cause serious or life-threatening bleeding. Tell your doctor if you currently have or have had a condition that causes you to bleed more easily than normal, if you have recently had surgery or been injured in any way, or if you have or have ever had a stomach ulcer; bleeding in your stomach, intestines, or head; a stroke or mini-stroke; a condition that may cause bleeding in your intestines such as polyps (abnormal growths in the lining of the large intestine) or diverticulitis (inflamed bulges in the lining of the large intestine); or liver disease. Tell your doctor and pharmacist if you are taking medications that may cause bleeding including anticoagulants (blood thinners) such as warfarin (Coumadin); heparin; other medications to treat or prevent blood clots; or regular use of a non-steroidal anti-inflammatory medications such as ibuprofen (Advil, Motrin) and naproxen (Aleve). Your doctor may not prescribe prasugrel for you if you have any of these conditions, you are taking any of these medications, you weigh less than 132 lb (60 kg), or you are older than 75 years of age. Your doctor also will probably not prescribe prasugrel if you are likely to need heart bypass surgery (a certain type of open heart surgery) right away. While you are taking prasugrel, you will probably bruise and bleed more easily than usual, bleed for longer than usual, and have nosebleeds. However, if you experience any of the following symptoms, call your doctor immediately: bleeding that is unexplained, severe, long-lasting, or uncontrollable; pink or brown urine; red or black, tarry stools; vomit that is bloody or that looks like coffee grounds; coughing up blood or blood clots; or bruises that are unexplained or that get larger.
If you are having surgery, including dental surgery, or any type of medical procedure, tell your doctor or dentist that you are taking prasugrel. Your doctor will probably tell you to stop taking prasugrel at least 7 days before your surgery is scheduled.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with prasugrel and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
Talk to your doctor about the risk of taking prasugrel.
Why is this medication prescribed?
Prasugrel is used along with aspirin to prevent serious or life-threatening problems with the heart and blood vessels in people who have had a heart attack or severe chest pain and have been treated with angioplasty (procedure to open the blood vessels that supply blood to the heart). Prasugrel is in a class of medications called anti-platelet medications. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke.
How should this medicine be used?
Prasugrel comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take prasugrel at around the same time 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 prasugrel exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablet whole; do not split, chew, or crush it.
Prasugrel will help prevent serious problems with your heart and blood vessels only as long as you take the medication. Do not stop taking prasugrel without talking to your doctor. If you stop taking prasugrel, there is a higher risk that you may have a heart attack, develop a blood clot, or die.
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 prasugrel,
- tell your doctor and pharmacist if you are allergic to prasugrel, any other medications, or any of the ingredients in prasugrel tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section.
- tell your doctor if you have or have ever had kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking prasugrel, call your doctor.
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?
Prasugrel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- excessive tiredness
- pain in the back, arms, or legs
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- purple patches on the skin
- yellowing of the skin or eyes
- shortness of breath
- slow, fast, or irregular heartbeat
- slow or difficult speech
- sudden weakness of an arm or leg
- stomach pain
- decreased urination
- swelling of the eyes, face, mouth, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
Prasugrel 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/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. The medication will come with a gray cylinder that helps keep the tablets dry; leave this cylinder in the container with the medication. 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.
What other information should I know?
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.