FDA approves Consensi

The U.S. Food and Drug Administration (FDA) has approved Consensi (amlodipine besylate and celecoxib), an antihypertensive calcium channel blocker and a non-steroidal anti-inflammatory drug (NSAID) combination for the treatment of hypertension and osteoarthritis pain.

Important information

Consensi contains celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), and amlodipine, a calcium channel blocker (CCB). NSAIDs can cause serious side effects, including:

Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:

with increasing doses of NSAIDs

with longer use of NSAIDs

Do not take Consensi right before or after a heart surgery called a “coronary artery bypass graft” (CABG).

Avoid taking Consensi after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines:

anytime during use

without warning symptoms

that may cause death

The risk of getting an ulcer or bleeding increases with:

past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs

taking medicines called “corticosteroids”, “anticoagulants”, “selective serotonin reuptake inhibitors (SSRIs)”, or “serotonin norepinephrine reuptake inhibitors (SNRIs)”

increasing doses of NSAIDs

longer use of NSAIDs

smoking

drinking alcohol

older age

poor health

advanced liver disease

bleeding problems

Consensi should only be used:

exactly as prescribed

at the lowest dose possible for your treatment

for the shortest time needed

Do not take Consensi:

if you are allergic to amlodipine, celecoxib or any of the inactive ingredients in Consensi. See the end of this Medication Guide for a complete list of ingredients.

if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.

right before or after heart bypass surgery

if you have had an allergic reaction to sulfonamides.

Before taking Consensi, tell your healthcare provider about all your medical conditions, including if you:

have heart problems.

have liver or kidney problems.

have asthma.

are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking Consensi during pregnancy. You should not take Consensi after 29 weeks of pregnancy.

are breastfeeding or plan to breastfeed. Consensi can pass into your breast milk. It is not known if Consensi will harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Consensi.

Consensi side effects

Consensi can cause serious side effects, including:

liver problems, including liver failure

worsening chest pain (angina) or heart attack, particularly in people with severe obstructive coronary artery disease

heart failure

swelling of your arms, legs, hands and feet (peripheral edema) is common with Consensi but can sometimes be serious.

kidney problems, including kidney failure

increased potassium levels (hyperkalemia)

life-threatening allergic reactions

life-threatening skin reactions

low red blood cells (anemia)

Your healthcare provider will monitor your blood pressure and do blood tests to check you for side effects during treatment.

Consensi may cause fertility problems in females that is reversible when treatment is stopped. Talk to your healthcare provider if this is a concern for you.

The most common side effects include:

swelling of the arms, legs, hands, and feet

joint swelling

dizziness

stomach pain

diarrhea

heartburn

headache

frequent urination

hot or warm feeling in your face (flushing)

gas

tiredness

extreme sleepiness

Get emergency help right away if you get any of the following symptoms:

shortness of breath or trouble breathing

chest pain

weakness in one part or side of your body

slurred speech

swelling of the face or throat

Stop treatment and call your healthcare provider right away if you get any of the following symptoms:

nausea

more tired or weaker than usual

diarrhea

itching

your skin or eyes look yellow

indigestion or stomach pain

flu-like symptoms

vomit blood

there is blood in your bowel movement or it is black and sticky like tar

unusual weight gain

skin rash or blisters with fever

swelling of the arms, legs, hands and feet

These are not all the possible side effects.

FDA approves Consensi

The U.S. Food and Drug Administration (FDA) has approved Consensi (amlodipine besylate and celecoxib), an antihypertensive calcium channel blocker and a non-steroidal anti-inflammatory drug (NSAID) combination for the treatment of hypertension and osteoarthritis pain. Important information Consensi contains celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), and amlodipine, a calcium channel blocker (CCB). NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take Consensi right before or after a heart surgery called a coronary artery bypass graft (CABG). Avoid taking Consensi after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called corticosteroids, anticoagulants, selective serotonin reuptake inhibitors (SSRIs), or serotonin norepinephrine reuptake inhibitors (SNRIs) increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems Consensi should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed Do not take Consensi: if you are allergic to amlodipine, celecoxib or any of the inactive ingredients in Consensi. See the end of this Medication Guide for a complete list of ingredients. if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery if you have had an allergic reaction to sulfonamides. Before taking Consensi, tell your healthcare provider about all your medical conditions, including if you: have heart problems. have liver or kidney problems. have asthma. are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking Consensi during pregnancy. You should not take Consensi after 29 weeks of pregnancy. are breastfeeding or plan to breastfeed. Consensi can pass into your breast milk. It is not known if Consensi will harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Consensi. Consensi side effects Consensi can cause serious side effects, including: liver problems, including liver failure worsening chest pain (angina) or heart attack, particularly in people with severe obstructive coronary artery disease heart failure swelling of your arms, legs, hands and feet (peripheral edema) is common with Consensi but can sometimes be serious. kidney problems, including kidney failure increased potassium levels (hyperkalemia) life-threatening allergic reactions life-threatening skin reactions low red blood cells (anemia) Your healthcare provider will monitor your blood pressure and do blood tests to check you for side effects during treatment. Consensi may cause fertility problems in females that is reversible when treatment is stopped. Talk to your healthcare provider if this is a concern for you. The most common side effects include: swelling of the arms, legs, hands, and feet joint swelling dizziness stomach pain diarrhea heartburn headache frequent urination hot or warm feeling in your face (flushing) gas tiredness extreme sleepiness Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing chest pain weakness in one part or side of your body slurred speech swelling of the face or throat Stop treatment and call your healthcare provider right away if you get any of the following symptoms: nausea more tired or weaker than usual diarrhea itching your skin or eyes look yellow indigestion or stomach pain flu-like symptoms vomit blood there is blood in your bowel movement or it is black and sticky like tar unusual weight gain skin rash or blisters with fever swelling of the arms, legs, hands and feet These are not all the possible side effects.