That is a particular worry in this case, since clinical trials were so short (only 3 months vs. the more usual 6 to 12 months, or longer).The statins on the market in the U.S. which can be combined with Zetia, are Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin).
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Zetia (ezetimibe) is a medicine used to lower levels of total cholesterol and LDL (bad) cholesterol in the blood. The companies’ principle marketing claim for Zetia has been improved safety over other cholesterol lowering drugs, particularly the statins, but with no actual proof that safety is, in fact, improved. This approval occurred despite the fact that the FDA Pharmacology Reviewer sounded a warning of serious safety concerns about the combination, and recommended Pharmacology recommends approval of this drug [ezetimibe] for monotherapy for the proposed indication [use], but preclinical studies do not support safety of ezetimibe in combination with statins. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. You should not use Zetia if you have moderate to severe liver disease. The FDA Alert(s) below may be specifically about Zetia or relate to a group or class of drugs which include Zetia (ezetimibe).
Most commonly, these are "non-preferred" brand drugs. Drug therapy may be needed to achieve these goals; medication is usually needed to reduce LDL cholesterol to 100 mg/dL and is almost always needed to reduce it to 70 mg/dL. In addition to the rhabdomyolysis, we found 83 reports of increased CPK blood levels in patients taking Zetia alone with only two cases of elevations in patients taking the combination Zetia with a statin. Follow all directions on your prescription label. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.Audience: Cardiovascular healthcare professionals and patientsGavreto (pralsetinib) is an oral selective RET kinase inhibitor for the...Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the...Qdolo (tramadol hydrochloride) is an opioid agonist indicated in adults for ...Xaracoll (bupivacaine hydrochloride) is a fully bioresorbable collagen implant...The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. But it doesn’t work as well as statins. Do not take this medicine in larger or smaller amounts or for longer than recommended.Zetia is usually taken once daily. For the latest FDA MedWatch alerts, Audience: Endocrinologists, cardiologists, other healthcare professionals, patientsFDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. You will need frequent blood tests to measure your cholesterol levels.Zetia is only part of a complete program of treatment that also includes diet, exercise, and weight control. The FDA subsequently approved the fixed combination pill of Vytorin (ezetimibe and simvastatin). When Zetia was combined with a statin, toxicity was seen in even more organs: liver, stomach, skeletal muscle, spleen, heart, lungs, testes, and prostate.Muscle: A major safety concern with cholesterol lowering drugs, particularly the statins, is the possibility of rhabdomyolysis, a breakdown of muscle. A number of new drugs have been withdrawn within their first seven years after release. You may also take ezetimibe 2 hours before taking any of these other medicines.You may need frequent blood tests to check your liver function if you take ezetimibe with a statin medicine.It may take up to 2 weeks before your cholesterol levels improve. Both Zetia and the fixed combination with simvastatin are co-promoted by Schering-Plough and Merck.
FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.
Combination with a Statin. Most commonly, these are generic drugs. Unlike the more common drugs like Lipitor, which block the enzyme your liver needs to produce cholesterol, Zetia actually works to reduce the absorption of cholesterol in the digestive tract. Zetia FDA Alerts.
Data sources include IBM Watson Micromedex (updated 2 Sep 2020), Cerner Multum™ (updated 1 Sep 2020), … Both Zetia and the fixed combination with simvastatin are co-promoted by Schering-Plough and Merck. The unpublished Zetia studies, devised as safety tests, would not prove the drug’s effectiveness. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.