Effient Warnings and Precautions
Because Effient can cause serious bleeding problems in certain people, tell your healthcare provider before starting treatment if you have recently had surgery, are over 75 years old, or have severe liver disease. Other safety precautions for Effient include warnings on following the dosing guidelines carefully and avoiding the drug if you have active bleeding, such as a bleeding stomach.
What Should I Tell My Healthcare Provider Before Starting Treatment?Prior to taking Effient® (prasugrel hydrochloride), talk to your healthcare provider if you have:
- A bleeding disorder
- Intestinal or stomach ulcers or bleeding
- Bleeding in the brain
- An aneurysm
- Severe liver disease, such as liver failure or cirrhosis
- A history of stroke or transient ischemic attacks (TIAs or "mini-strokes")
- Any allergies, including to food, dyes, or preservatives.
Also, let your healthcare provider know if you:
- Will be having surgery
- Are pregnant or thinking of becoming pregnant
- Are breastfeeding.
Make sure to tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Specific Precautions and Warnings With EffientWarnings and precautions to be aware of prior to taking Effient include the following:
- One of the most serious Effient side effects is bleeding, including potentially fatal internal bleeding. People at the highest risk for this problem include those who:
- Are 75 years of age or older
- Undergo a heart bypass surgery
- Weigh 132 pounds or less
- Have suffered a recent physical trauma
- Have had a recent surgery
- Have recent or recurrent gastrointestinal bleeding or ulcers
- Have severe liver disease
Effient should not be given to any individual with active bleeding.
- In general, the risks of Effient outweigh the benefits for people age 75 or older, except in special groups, such as those with diabetes or a history of a previous heart attack. Before recommending this medication to elderly individuals, healthcare providers must carefully consider the benefits and risks for the individual.
- Let your healthcare provider know if you develop any signs of bleeding, such as:
- Easy bruising
- Cuts or scrapes that are slow to stop bleeding
- Black, tarry stools; bright-red blood in the stool; or vomiting of blood (signs of gastrointestinal bleeding)
- Signs of bleeding in the brain, such as vision or speech changes, weakness or numbness in an arm or leg, or a severe headache.
- Effient should not be given to people who have had a stroke or transient ischemic attacks (TIAs, commonly known as "mini-strokes"). Studies suggest that the drug increases the risk of strokes in such people.
- This medication should not be given to people who are likely to need heart bypass surgery. If a person already taking Effient needs to have a bypass, the procedure should be postponed for seven days if possible, in order to decrease the risk of life-threatening bleeding.
- Effient should be stopped ahead of time for any elective surgery. Ask your healthcare provider when you should stop and restart it.
- Effient may interact with a few different medications (see Effient Drug Interactions).
- At this time, it is not entirely clear how long people should continue to take Effient, and different healthcare providers may have different opinions on this matter. Your healthcare provider will take into account your particular situation when recommending how long you should take it. Stopping the medicine too soon may increase your risk of heart attacks, blood clots in your stent, and death.
- Medications like Effient have been linked to a serious condition known as thrombotic thrombocytopenic purpura (TTP). Be sure to let your healthcare provider know right away if you develop any symptoms of TTP, such as:
- Effient is a pregnancy Category B medication, which means it is probably safe for use during pregnancy, although the full risks are currently unknown (see Effient and Pregnancy for more information).
- At this time, it is unknown if this medicine passes through breast milk in humans. If you are breastfeeding or plan to start, discuss this with your healthcare provider prior to beginning treatment (see Effient and Breastfeeding for more information).