Label Changes for:
Tekturna (aliskiren) tablets
November 2009
Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009
BOXED WARNING
WARNING: Avoid Use in Pregnancy
- When pregnancy is detected, discontinue Tekturna as soon as possible. Drugs that act directly on the reninangiotensin system can cause injury and death to the developing fetus.
WARNINGS AND PRECAUTIONS
Fetal/neonatal mobidity and mortality
- If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Impaired Renal Function
- Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances particularly in patients with severe renal impairment.
Head and Neck Angioedema (section revised)
- Discontinue Tekturna immediately in patients who develop angioedema, and do not readminister.
ADVERSE REACTIONS
Clinical Studies Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
DRUG INTERACTIONS
Effects of Aliskiren on Other Drugs
- Patients receiving furosemide could find its effect diminished after starting aliskiren
USE IN SPECIFIC POPULATIONS
Pregnancy
- When pregnancy is detected, Tekturna should be discontinued as soon as possible.
PATIENT COUNSELING INFORMATION
Information for Patients (added)
- Symptomatic Hypotension...
- Potassium Supplements...
- Relationship to Meals...
FDA Approved Patient Labeling
- What Is High Blood Pressure? Drugs that lower blood pressure lower your risk of having a stroke or heart attack.
- Who Should Not Take Tekturna? Do not take Tekturna if you are allergic to any of its ingredients, See the end of this leaflet for a complete list of the ingredients in Tekturna.
- What Are Possible Side Effects Of Tekturna?
- Angioedema...
- Common side effects of Tekturna include...
- How Do I Store Tekturna? Medicines are sometimes prescribed for condition not listed in the patient information leaflet. Do not take Tekturna for a condition for which is was not prescribed. ...If you have more questions about Tekturna talk with your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.
- What Should I Tell My Doctor Before Taking Tekturna? Have ever had a reaction called angioedema, to an ACE inhibitor medicine. Angioedema causes swelling of the face, lips, tongue, throat, arms, and legs, and may cause difficulty breathing.
- Tell your doctor about all the medicines you take...Atorvastatin (medicine to lower cholesterol in your blood)
- What Are Possible Side Effects Of Tekturna? Injury or death to an unborn baby.
- How Should I Take Tekturna? Tekturna can be taken by itself or safely in combination with other medicines to lower high blood pressure. Your doctor may change your dose if needed.
