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LDL-lowering medication approved

The FDA has approved Amgen's evolocumab (Repatha) for lowering low-density lipoprotein (LDL) cholesterol levels. It is indicated for use in addition to diet and maximally tolerated HMG-CoA reductase inhibitor (statin) therapy in adults with heterozygous and homozygous familial hypercholesterolemia (FH) or clinical evidence of atherosclerotic cardiovascular disease who require further LDL-cholesterol lowering.


Evolocumab is the second proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor approved in the United States. Evolocumab is a human monoclonal antibody that binds to PCSK9 and inhibits the binding of PCSK9 to low-density lipoprotein receptors (LDLRs) in hepatocytes of the liver. By blocking PCSK9's ability to work, more LDLRs are available to remove LDL-C from the blood and lower LDL-C levels.


The FDA's approval of evolocumab is based on data from clinical trials of patients with heterozygous and homozygous FH, patients unable to tolerate statins, and patients at high risk for cardiovascular events who are not adequately controlled on statin therapy.


The most common adverse reactions of evolocumab include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and redness, pain, or bruising at the injection site. For more prescribing information, consult product labeling.


OxyContin approved for some pediatric patients

The extended-release opioid oxycodone (OxyContin) has been approved for pediatric patients ages 11 and older with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.


The FDA requested that Purdue Pharma LP, the maker of OxyContin, conduct studies evaluating the use and safety of the medication in patients ages 11 to 16 to support a pediatric indication for the drug. The new study data give healthcare providers more information on how to safely manage pain in pediatric patients following surgery or trauma.


Pediatric patients must already be responding to and tolerating a minimum opioid dose equal to at least 20 mg of oxycodone or its opioid equivalent per day for 5 consecutive days before they can be prescribed an equivalent dose of OxyContin. OxyContin is not intended to be the first opioid drug used in pediatric patients, but the data showed that changing from another opioid drug to OxyContin is safe if done properly.


Warnings and precautions on the drug's labeling is the same for pediatric and adult patients.


New combination medication for type 2 diabetes approved

A new medication for type 2 diabetes mellitus, Synjardy, has been approved that combines the sodium glucose cotransporter 2 inhibitor empagliflozin with metformin hydrochloride in a single pill. The medication is a product of the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance.

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Synjardy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled with either empagliflozin or metformin monotherapies, or in patients already being treated with empagliflozin and metformin. It is not indicated for type 1 diabetes mellitus or diabetic ketoacidosis.


The medication contains a warning on its labeling about the risk of lactic acidosis, as does all metformin-containing medications.


Drug safety communication issued on fingolimod

The FDA recently warned that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking fingolimod (Gilenya) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking fingolimod who had not been previously treated with an immunosuppressant drug for MS or another medical condition. Prior to this report, fingolimod could not be conclusively linked with PML.

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Healthcare providers should report adverse events or adverse reactions related to the use of fingolimod to the FDA's MedWatch Safety Information and Adverse Event Reporting Program and consult the FDA's recommendations.