" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
Advise the Patient
- To contact their healthcare provider or go to the emergency department right away if a hypersensitivity reaction occurs. Early signs of hypersensitivity reactions may include rash, hives, itching, facial swelling, tightness of the chest, and wheezing [see WARNINGS AND PRECAUTIONS].
- To contact their physician or treatment center for further treatment and/or assessment if they experience a lack of clinical response to factor VIII replacement therapy, as this may be a manifestation of an inhibitor [see WARNINGS AND PRECAUTIONS].
- To contact their healthcare provider or go to the emergency department right away if a thromboembolic event should occur [see WARNINGS AND PRECAUTIONS].
- That despite stringent procedures designed to reduce risk, the risk of transmitting infectious agents cannot be totally eliminated. Advise patients, especially pregnant women and immunocompromised individuals, to report any signs and symptoms of fever, rash, joint pain, or sore throat, to their physician immediately [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 5/2/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Alphanate Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.