ISSUE: A recently published study - a meta-analysis combining cancer-related findings from several clinical trials - suggested use of angiotensin receptor blockers (ARBs) may be associated with a small increased risk of cancer.
BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Brand names include Atacand (candesartan), Avapro (irbesartan), Benicar (olmesartan), Cozaar (losartan), Diovan (valsartan), Micardis (telmisartan), and Teveten (eprosartan).
The meta-analysis included data from over 60,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. The mean duration of follow-up ranged from 1.7 to 4.8 years.
The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). No statistically significant difference in cancer deaths was noted.
RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Do not take telmisartan if you are pregnant. If you become pregnant while taking telmisartan, call your doctor immediately. Telmisartan may harm the fetus.
Before taking telmisartan,
tell your doctor and pharmacist if you are allergic to telmisartan or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); digoxin (Lanoxin); and diuretics ('water pills'). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had heart failure or kidney or liver disease.
tell your doctor if you plan to become pregnant or are breast-feeding.
What side effects can this medication cause?
Telmisartan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
Telmisartan 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 storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. 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.
Symptoms of overdose may include:
rapid or pounding heartbeat
What other information should I know?
Keep all appointments with your doctor. Your blood pressure should be checked regularly to determine your response to telmisartan.
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.
AHFS® Consumer Medication Information. © Copyright, 2011. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Brand names of combination products
Micardis-HCT 40/12.5 (containing Hydrochlorothiazide and telmisartan)
Micardis-HCT 80/12.5 (containing Hydrochlorothiazide and telmisartan)
Micardis-HCT 80/25 (containing Hydrochlorothiazide and telmisartan)
Twynsta 40/10 (containing Amlodipine and telmisartan)
Twynsta 40/5 (containing Amlodipine and telmisartan)
Twynsta 80/10 (containing Amlodipine and telmisartan)
Twynsta 80/5 (containing Amlodipine and telmisartan)
Generic Name: telmisartan (TEL mi SAR tan)
Brand Names: Micardis
What is Micardis?
What does 140 over 90 mean? Learn about high blood pressure numbers.
Micardis (telmisartan) is in a group of drugs called angiotensin II receptor antagonists. It works by decreasing certain chemicals in the body that cause blood vessels to constrict and sodium and fluid to be stored by the kidneys.
Micardis is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.
Micardis is also used to reduce the risk of stroke, heart attack, or death from heart problems in people who are at least 55 years old with risk factors for serious heart disorders.
Micardis may also be used for other purposes not listed here.
Important information about Micardis
Do not use Micardis if you are pregnant. Telmisartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using Micardis and tell your doctor right away if you become pregnant during treatment. You should not use this medication if you are allergic to telmisartan. Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of Micardis. Do not use potassium supplements or salt substitutes while you are taking Micardis, unless your doctor has told you to.
To be sure Micardis is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.
If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.
In rare cases, Micardis can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.
Before taking Micardis
You should not use Micardis if you are allergic to telmisartan.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Micardis:
- kidney disease;
- liver disease;
congestive heart failure; or
if you are dehydrated.
FDA pregnancy category D. Do not use Micardis if you are pregnant. Micardis may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment. It is not known whether telmisartan passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
See also: Micardis pregnancy and breastfeeding warnings (in more detail)
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What should I avoid while taking Micardis?
Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of Micardis. Do not use potassium supplements or salt substitutes while you are taking Micardis, unless your doctor has told you to.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Micardis side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. In rare cases, Micardis can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.
Call your doctor at once if you have any other serious side effects such as:
feeling like you might pass out;
painful or difficult urination;
feeling short of breath, even with mild exertion; or
swelling in your hands or feet.
Less serious Micardis side effects may include:
runny or stuffy nose, sore throat, cough;
stomach pain, diarrhea;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effectsl. You may report side effects to FDA at 1-800-FDA-1088.
See also: Micardis side effects (in more detail)
What other drugs will affect Micardis?
Before taking Micardis, tell your doctor if you are using any of the following drugs:
a diuretic (water pill); or
digoxin (digitalis, Lanoxin).
This list is not complete and there may be other drugs that can interact with Micardis. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More Micardis resources
Compare Micardis with other medications
- Micardis Generic Telmisartan (TEL mi SAR tan)
- micardis - Google Search
- TELMISARTAN - ORAL (Micardis) side effects, medical uses, and drug interactions.
- Angiotensin Receptor Blockers Linked to Cancer - CBS News
- Telmisartan - Wikipedia, the free encyclopedia
- Micardis HCT (Telmisartan, Hydrochlorothiazide) Drug Information: User Reviews, Side Effects, Drug Interactions and Dosage at RxList
- Micardis Information from Drugs.com
- Telmisartan - PubMed Health