It is a well known fact that breastfeeding is best source of nutrition for infants. Breast milk provides minerals, vitamins and antibodies in most acceptable format when they need it. Nutrition taken by mother passes to breast-milk and same thing applies to medicines taken by mothers. Not all drugs cause problem for baby but some do. Lets analyze if Tricor | Fenofibrate Tablet is safe for baby while breastfed.
What is Tricor | Fenofibrate Tablet used for?
TRICOR is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). For treatment of adult patients with severe hypertriglyceridemia (1.2). Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1). 1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia TRICOR is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. 1.2 Severe Hypertriglyceridemia TRICOR is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. 1.3 Important Limitations of Use Fenofibrate at a dose equivalent to 145 mg of TRICOR was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
I am breastfeeding mother and I am using Tricor | Fenofibrate Tablet. Can it have any bad effect on my kid? Shall I search for better alternative?
Tricor | Fenofibrate Tablet contains only one active ingredient that is Fenofibrate. We have analyzed the usage of Fenofibrate in breastfeeding and our analysis suggest that Fenofibrate poses Low risk for infant while breastfeeding and hence Tricor | Fenofibrate Tablet itself shall be considered Low risk item for breastfeeding.
Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Fenofibrate should not be used in nursing mothers. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Tricor | Fenofibrate Tablet Breastfeeding Analsys
Fenofibrate while Breastfeeding Low Risk
CAS Number: 49562-28-9
Fenofibrate, like other fibrates, decreases elevated blood lipids (triglycerides and cholesterol) by increasing the activity of lipases that catabolize triglyceride-rich lipoproteins and slightly decreasing cholesterol biosynthesis (AEMPS 2017, BGP 2015, Miller 1998). In general, fibrates have a discrete effect on the increase of high density lipoprotein (HDL) concentration and the reduction of low density lipoprotein (LDL). Since the last update we have not found published data in relation to breastfeeding. Its high binding to plasma proteins makes it unlikely it will pass into breast milk. Cholesterol levels in milk are very stable even in hypercholesterolemic women and are not severely affected by diet or nutritional status of the mother, suggesting that 3 is synthesized, at least in part, in the mammary gland (Lawrence 2016, p 289-90).It is not probable therefore, but it is not known if the fibrates are able to alter the lipid composition of the milk. Infants need to ingest large amounts of cholesterol, as it is critical to the proper development of the nervous system, cell membranes and is a precursor of several hormones and vitamins. Until there is more data in relation to breastfeeding, it is prudent to avoid using it, at least while breastfeeding exclusively. Suspending the pharmacological treatment of hyperlipidemia during breastfeeding is not likely to alter the long-term outcome of the disease, especially when breastfeeding can be considered therapeutic (Lawrence 2016, p.393). It is advisable to follow a lipid-lowering diet. In case of administering a fibrate during breastfeeding it is advisable to choose those with a shorter half-life: bezafibrate, gemfibrozil.
Tricor | Fenofibrate Tablet Breastfeeding Analsys - 2
Fenofibrate while Breastfeeding
CAS Number: 49562-28-9
No relevant published information exists on the use of fenofibrate during breastfeeding. Because of a concern with disruption of infant lipid metabolism, fenofibrate is best avoided during breastfeeding. An alternate drug is preferred, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be avoided during fenofibrate therapy and for 5 days after the final dose.
What should I do if already breastfed my kid after using Tricor | Fenofibrate Tablet?
During whole lactation period you shall first discuss with your doctor and then together you shall decide whether you shall take that drug or not however if you have already taken Tricor | Fenofibrate Tablet then you shall inform your doctor, But you should not be worried too much as Tricor | Fenofibrate Tablet comes in category of low risk drug.
I am nursing mother and my doctor has suggested me to use Tricor | Fenofibrate Tablet, is it safe?
Though Tricor | Fenofibrate Tablet dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.
If I am using Tricor | Fenofibrate Tablet, will my baby need extra monitoring?
Who can I talk to if I have questions about usage of Tricor | Fenofibrate Tablet in breastfeeding?
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week