People of Chinese descent are more likely to develop myopathy. If its a problem when taking simvastatin, ask the prescribing healthcare provider for medical advice. However, patients requiring ongoing statin treatment should not breastfeed and instead use infant formula or other alternatives. Pharmacy names, logos, brands, and other trademarks are the property of their respective owners. Atorvastatin (Lipitor): Top 12 Drug In some instances, after doctors have prescribed a drug for 10 years or more, it is taken off the market because of unforeseen, adverse side effects. Major has lisinopril 20 mg tablets in unit-dose blister packs on back order and the company estimates a release date in late-June 2023. Crestor These problems usually improve when the drug is stopped. Both forms are taken by mouth. Yet Another Blood Pressure Medication Recall Due 5 mg Simvastatin Tablets, 90-count bottle and 1000-count bottle. Besides taking the medicine correctly, another sure way to avoid the side effects of statins is to make sure the prescribing healthcare provider has a complete picture of your health conditions. Usually, the FDA (or a manufacturer) will order a recall on one date, then classify the severity of the recall as either Class I, II, or III at a later date. Patients should be aware of the following information: Statins also can lower the risk for heart attack and stroke in patients who have heart disease or risk factors for it. Consumers with medical questions about the recall can contact Aurobindo Pharma at 866-850-2876 or email the company at pvg@aurobindousa.com. Initial clinical trials put the incidence at about 2%, but the real-world incidence may be more than 6%. United States including Puerto Rico and Canada. The World Health Organization (WHO) considers it one of the safest, most effective, essential medications on the market. Rosuvastatin: 7 things you should you know about ACCORD pharmaceuticals Rosuvastatin calcium oral tablet, Sometimes a medicine is recalled because of confusing dosing instructions or a problem with the dosing tool provided with the drug. What to Do if a Drug You're Taking Is Recalled, Drug Recalls: Why They Happen and What You Should Do, Valsartan, Losartan & Other BP Med Recalls 2018-19, Medication Safety: Side Effects, Medication Disposal, Expiration Dates, and More, FDA's MedWatch Safety Alerts: August 2009. Healthcare professionals sometimes call them HMG-CoA reductase inhibitors, but its easier just to call them statins. They found a miscarriage rate of 25% in statin-exposed versus 21% for controls. Upper respiratory infections are the most common complaint among simvastatin users. Simvastatin tablets are used to lower cholesterol in individuals who have been diagnosed with high cholesterol. Stop taking simvastatin and contact a healthcare professional if muscles start to hurt or become weak. When FDA approved the first statin in 1987, the medicine came with our strongest warning recommending against use during pregnancy and breastfeeding. Theres a partial list below and a more complete list on this page. If the recall involves a prescription drug, call your doctor or pharmacist as soon as possible to find out what replacement is needed. PTI. WebA prescription statin used to treat high cholesterol and coronary heart disease is being recalled. These include fibrate cholesterol drugs like fenofibrate, corticosteroids, some malaria drugs, and alcohol. Reduced doses may help, but some people may need to switch to a different statin or a different type of cholesterol drug. 1. For More Info The list below includes voluntary recalls in which public notification has been issued. BJOG 2013;120:463-71. Cognitive side effects, like memory problems and confusion, may be an issue with simvastatin and related drugs. Simvastatin Information, Side Effects, Warnings and Recalls If a dose is missed, it can be taken when remembered, unless its almost time for the next dose. Whats the Difference Between a Class I, Class II, and Class III Recall? You can email the site owner to let them know you were blocked. Reason: Label Mixup (Simvastatin Tablets possibly mislabelled as Losartan Potassium). Rarely, The supplement is also widely prescribed to enhance cardiovascular health and wellbeing. Reassure patients who have an unintended exposure to statins in early pregnancy that it is unlikely to cause harm to the developing fetus. Hello! Urgent, with immediate and significant danger of death and/or serious injury. All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. In clinical trials, the incidence was close to 1 in 10 participants. Simvastatin is also very popular (46 million dispensed prescriptions). Because the benefits of statins may include prevention of serious or potentially fatal events in a small group of very high-risk pregnant patients, contraindicating these drugs in all pregnant women is not appropriate. Drug Route. truths about statins and high cholesterol 1 Despite the widespread use of statins to lower cholesterol and reduce cardiovascular morbidity and mortality, However, because statins decrease the bodys ability to make cholesterol and possibly other substances, it is possible these medicines could harm an unborn baby when taken by a pregnant mother (See Data Summary for more details). Atorvastatin belongs to the class of medicines known as statins. WebMulti event Drug Recall Enforcement Report Class II voluntary initiated by Preferred Pharmaceuticals, Inc., originally initiated on 03-23-2023 for the product Simvastatin FDA is requesting that manufacturers of cholesterol-lowering statins remove the contraindication included in the current prescribing information stating these medicines should never be used in patients during pregnancy. WebNovartis sells off dry eye disease med Xiidra, other ophthalmology assets to Bausch + Lomb for $2.5B. The major recalls originated from Micro Labs USA and Biocon, Inc. Inform the prescriber about all medical problems, 4. MEDICATION RECALL ADVISORY Voluntary Nationwide Recall Statin drugs are used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol ("bad cholesterol"). Simvastatin oral tablet is available as the brand-name drug Zocor. Unfortunately, some health risks associated with certain medications are not realized until after they become widely used. This may have overestimated statin use in the study population. They are available as brand-name and generic products. Despite the change, most patients should stop statins once they learn they are pregnant. Many older studies did not report or discuss the rate of miscarriage; however, three studies included miscarriage in their analyses and did not find an increased risk once adjustments were made for confounders.3, 9, 10 In 2009, McGrogan et al.8 reported an adjusted risk ratio for terminations of 2.48 (95% CI 1.65-3.73). To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this sheet. There were a few other relatively minor recalls (less than about 1,000 bottles each), with one also from Micro Labs USA. Drugs in short supply often include sterile injectables and potentially life-saving oncology (cancer) treatments. Toprol XL (metoprolol succinate) doesn't work for everyone. Healthcare professionals sometimes call them HMG-CoA reductase inhibitors, but its easier just to call them statins. You can sign up for email alerts about Drug Safety Communications on medicines or medical specialties of interest to you. If constipation occurs when taking any drug, the best advice is to consult with the prescribing healthcare provider. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". Before sharing sensitive information, make sure you're on a federal government site. For more about how much you can save with MedPro, see this useful savings calculator. To clarify, weve defined the three different recall classes here. Applies to atorvastatin: oral tablets. Recall FDA reviewed data from case series and prospective and retrospective observational cohort studies over decades of use of statins in pregnant women.1-15 Multiple larger, well-designed, and controlled observational studies did not find an increase in major birth defects associated with use of statins during pregnancy. Medicine is rigorously tested for safety and effectiveness before becoming available to the consumer. Pollack PS, Shields KE, Burnett DM, Osborne MJ, Cunningham ML, Stepanavage ME. Rosuvastatin calcium oral tablet, Apotex, 40 mg, bottle, 30 count, NDC 60505-4505-03 - discontinued. Three dosages are being recalled: 13,464 bottles of the 80 mg, 13,488 of the 40 mg, and 27,144 of the 20 mg, Is poorly manufactured. SIMVASTATIN Recall D-0411-2023 Product Safety Recalls CNN . If things are easily forgotten, or you start feeling confused or disoriented, talk to the prescribing healthcare provider. As per the information available on the US Food and Drug Administration website, Micro Labs USA is recalling certain lots of the drug in various strengths--20 mg, Upsides. The full list of all Simvastatin recalls from through 2017 is below. (2.1) Due to the increased risk of myopathy, including rhabdomyolysis, use of the 80-mg dose of simvastatin should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. No one knows for certain why statins harm muscles in some people, but there may be higher risk due to age, genetics, medical conditions, and drug interactions. Oxybutynin side effects include dry mouth, dizziness, and constipation. Should tolerance of the medication be something of an issue for a patient, an alternate day dosage strategy can be considered. Half the recalls listed in this reference are Class II. If its a problem when taking simvastatin, ask the prescribing healthcare provider for medical advice. None of the other statins, including the ultimately doomed cerivastatin (Baycol) had any cases of rhabdomyolysis prior to approval and the primary renal toxicity (separate from the secondary renal damage , nelfinavir, darunavir, and the antiviral booster cobicistat, Finally, healthcare providers are wary about combining simvastatin, a drug that can damage muscles, with other drugs that can damage muscles. Since then, multiple randomized trials and meta-analyses have demonstrated the benefit of statin therapy on the prevention of cardiovascular events. Statins More common side effects are headaches, constipation, and nausea. While rosuvastatin 40 mg and atorvastatin 80 mg are very similar in terms of LDL-cholesterol lowering, Khera said, there are select patients where a generic rosuvastatin Blood pressure medication recalled over cancer risk concerns DOZENS of blood pressure pills have been recalled from pharmacy shelves because they contain a chemical linked to cancer. Lupin Pharmaceuticals recalls 2 blood pressure medications : NPR These were safety signals from animal data at drug exposures higher than human doses, potential concern that lowering cholesterol may negatively affect the unborn baby or infant, and the perspective that short-term use during pregnancy and breastfeeding did not provide a substantial benefit to the mother. Their mode of action is primarily via inhibition of HMG-CoA (hydroxymethylglutaryl-coenzyme A) reductase, the rate-limiting enzyme in the cholesterol biosynthesis pathway. The FDA will also determine the public hazard The first date is the issue date and the second is the classification date. Geburtshilfe Und Frauenheilkunde 2008;68:S130. Atherosclerosis is a chronic process and the temporary discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. So far there have been no incidents in 2017. . Among the removed brands are two for chronic obstructive pulmonary disease (COPD), a chronic inflammatory lung disease that causes obstructed airflow from In recent years, however, Khera has relied more heavily on generic atorvastatin and simvastatin because these drugs were cheaper and provide similar potency. Simvastatin is a generic form of Zocor, a statin medication first developed by Merck in the early 1990s. Your health care professional will be able to advise whether you should stop taking the medicine during pregnancy and whether you may stop your statin temporarily while breastfeeding. Description . The estimated incidence is that 1% of patients will experience memory impairment, 1% will experience amnesia (memory loss), and 1% will feel confused at times when taking simvastatin. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins, What safety information is FDA announcing. Some statins have been shown to pass into human milk and may cause harm to the breastfed infant based on the mechanism of action. Rarely, severe muscle pain and rhabdomyolysis (a breakdown in muscle tissue) have been reported. FDA expects removing the contraindication will enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke. To date, there havent been any Class I recalls of Simvastatin, and there have been no recalls of the drug of any kind in 2017. WebFDA: Limit Use of 80 mg Simvastatin. recall The recall includes 90-count bottles of atorvastatin calcium tablets, 10 mg (NDC 70377-027 The last time we checked, atorvastatin was the most widely prescribed drug in the United States (114 million bottles dispensed in 2018). Description: Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Simvastatin Information | FDA Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor. The exact incidence is unknown. Simvastatin recalls are grouped by an FDA class number. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. as well as people who have risk factors for cardiovascular disease. Atorvastatin Side Effects The risk of muscle pain from Zetia (ezetimibe) alone is likely Patients who are at high risk of heart attack or stroke who require statins after giving birth should not breastfeed and should use alternatives such as infant formula. , low-density lipoprotein cholesterol (LDL), and triglycerides (fats) in the bloodstream. The biggest recall of the popular lipid-control drug yet was the 2015 Class III recall by Micro Labs. Description: Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9 SIMVASTATIN Recall D-0523-2023 Information Status

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