Why was fluvastatin discontinued?
Living in the modern world makes so many things more accessible and easily available. The simplest things can be seen such as food consumption where in current times is so different from what was seen 20 years ago. This is the same as what goes into the world of medicine. For example, morphine that is known as “God’s own medicine” that makes it so widely used in the past, is now seen as a danger when it is not used properly without medical advice. In this DoctorOnCall’s article, we will learn fluvastatin and the reason behind its discontinuation.
Fluvastatin belongs to a group of drugs known as statins or specifically, HMG-CoA reductase inhibitors. Statins in general works by reducing the production of cholesterol in the body that is made by the liver. Fluvastatin also is used to decrease the amount of bad cholesterol known as LDL cholesterol and triglycerides while increasing the amount of the good cholesterol known as HDL cholesterol in blood. In general, fluvastatin is used in conjunction with diet, weight loss and exercise to reduce risk for heart attack and stroke. It also helps in reducing the chance for heart surgery in those who have had heart disease or at risk of developing heart disease.
While fluvastatin is given to adults with the reasons mentioned above, fluvastatin is also indicated for children and adolescents aged 10 to 16 with heterozygous familial hypercholesterolemia. Fluvastatin is given in this group of age when they are unresponsive or failed to diet and LDL cholesterol remains high. The Reason fluvastatin is needed to reduce cholesterol in fats is to improve the heart and blood vessel function. This is because accumulation of cholesterol and fats along the wall of arteries can lead to decrease of blood flow which then results in low oxygen supply to many parts of the body. Compromised blood flow to the vital organs such as heart and brain can lead to higher chances for a heart attack or stroke respectively.
Fluvastatin comes in 20 mg and 40 mg immediate-release capsules and 80 mg extended-release tablets, taken by mouth. Capsule is typically taken with or without food once a day at bedtime or twice a day. The extended-release tablet is usually taken once a day without food. Patients are advised to take fluvastatin around the same time of day. This can ensure patients remember taking it on a daily basis. Fluvastatin needs to be taken as a whole and not to be crushed, split or chewed on. Taking it as a whole ensures the medicine works properly and in full dosage for high effectivity. Doctors typically advise patients to take fluvastatin in low doses initially and gradually increase the dose. It may take up to 4 weeks before a patient is able to see the benefit. Patients should continue to take fluvastatin even when they feel well and not to stop taking it without getting advice from their doctor.
Now that you know a lot more about fluvastatin, you may wonder, if the medicine seems good in general and works in helping patients, why was it discontinued then? It is worth noting that what is discontinued is the certain brand which is Lescol. The generic version of fluvastatin has been approved by the U.S. Food and Drug Administration (FDA). Generic versions are prescription drugs that have the same active ingredients but look different and contain different non-active ingredients compared to the brand-name medicine, which is in this case, different from Lescol.
Lescol XL contains fluvastatin sodium and is supplied as extended-release tablets with dose of fluvastatin of 80 mg. Reason for its discontinuation is due to manufacturing issues. Lescol capsule 20 mg is discontinued in Australia, cancelled under the Section 30(1C) of the Act which explains there is risk for serious illness or serious injury for the drug. Discontinuation of Lescol capsule 40 mg is issued by Singapore which changes the shell life from 36 months to 24 months due to stability profile of the drug substance susceptible towards high temperature and high humidity content in the hard gelatine capsule.
Treatment using fluvastatin in general is discontinued for a number of reasons. This includes its adverse events or side effects such as increased transaminase, upper abdominal pain, dyspepsia, fatigue and diarrhoea. Fluvastatin is also discontinued in patients who are found pregnant as there is great hazard to the fetus.
In essence, fluvastatin belongs to a group of statins. It works by reducing the amount of cholesterol produced by the liver. This in turn helps to maintain the healthy level of fats in blood. Such measures will help reduce the risk for heart disease. Fluvastatin is often given when lifestyle changes are not enough to control blood cholesterol. Discontinuation of fluvastatin depends on the dosage and brands. It is best to talk with your doctor if you have doubts when taking medicine and always remember to follow all doctor’s advice or instructions when taking the prescribed medicine.
