Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
January 17, 2014
Health Canada has issued new restrictions concerning the use of Effient (prasugrel). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Bleeding problems: Prasugrel increases the risk of bleeding because it reduces the ability of your blood to clot. People who weigh less than 60 kg (132 pounds) should not use prasugrel due to an increased risk of bleeding. Using other blood thinners (e.g., warfarin, NSAIDs) and blood clot dissolving drugs (e.g., alteplase) may further increase the risk of bleeding.
If you experience signs of serious or excessive bleeding (easy bruising, bleeding from the rectum, red or black stools, bloody urine, persistent abdominal pain and vomiting, coughing up blood), contact your doctor immediately.
If you have a history of bleeding disorders, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Thrombotic thrombocytopenic purpura (TTP) is a rare condition that may occur while taking prasugrel and that requires immediate medical attention. Signs include decreased number of blood cells, reduced kidney function, and fever. Your doctor will order blood tests to monitor for this condition while you are taking prasugrel.
Heart problems: There is an increased risk of bleeding if prasugrel is started in the hospital before your doctor checks the heart arteries with a procedure known as an angiogram. This risk is something that your doctor will consider before starting the medication.
If you are already taking prasugrel, this risk does not affect your situation and you should not stop taking the medication without first speaking to your doctor.
Lactose intolerance: This medication contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take this medication.
Liver function: If you have decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with severely reduced liver function should not take prasugrel.
Stomach problems: Since prasugrel can increase the risk of bleeding, it is important to remind your doctor if you have had stomach ulcers, and have the doctor or pharmacist review your medications to determine if they may cause stomach ulcers (e.g., NSAIDs such as ibuprofen, naproxen, and others). Bleeding in the digestive system is a medical emergency. If you experience signs of bleeding in the stomach, intestines, or rectum, such as black and tarry stools, vomiting blood, or blood in the stools, seek medical help immediately.
Stopping prasugrel: Do not stop taking prasugrel suddenly as this increases the risk of blood clots, heart attack, and death. If you need to stop taking prasugrel due to bleeding problems, your doctor should monitor you for any blood clots.
Surgery: Your doctor may want you to stop taking prasugrel at least 7 days prior to any planned surgery to prevent any unnecessary bleeding. However, you should not stop taking prasugrel without talking to your doctor first. It is important to tell any doctors including your dentist that you are taking prasugrel if you plan to have any surgery or dental procedure.
Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if prasugrel passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Seniors are generally at increased risk for bleeding with or without medications. Because of the increased risk of bleeding with this medication, prasugrel is not recommended for people over 75 years of age unless the benefits outweigh the risks.