In a legal settlement that’s much talked about, FDA agreed to allow the drug company Amarin to market its prescription omega-3 fatty acid product for off-label use.Amarin’s icosapent ethyl (Vascepa) is FDA approved to treat extremely high triglyceride values of 500 mg/dL or above. Although physicians commonly prescribe the medication for off-label use, the agreement would allow Amarin to market Vascepa to patients with high triglyceride levels of 200 mg/dL to 499 mg/dL.Saseen also believes the decision could open a “floodgate” for other companies that are seeking to promote their prescription medications for off-label use. Other experts agree that the decision would signal to other drug companies that they may be able to negotiate with FDA.In 2015, Amarin sued FDA for the right to market Vascepa to a larger group of patients. The court ruled in Amarin’s favor and said prohibiting Amarin from disseminating truthful information about the medication was a violation of free speech. FDA decided not to appeal the judge’s ruling.The final settlement must still be approved by a federal judge.“Based on the unusual circumstances of this case and the scientific information known to the FDA at this time, the agency does not anticipate a substantial adverse impact on public health resulting from this agreement,” said FDA in a statement.FDA is encouraging health care providers to continue to use their best clinical judgment based on all available scientific information about use of Vascepa for individual patients.Many unknownsLike other omega-3 fatty acids, Vascepa provides a dose-dependent reduction in triglyceride levels. But much is still unknown about omega-3 fatty acids, and the mortality benefit of triglyceride reduction with Vascepa is unclear for patients with triglyceride levels less than 500 mg/dL, according to Evan Sisson, PharmD, associate professor in the department of pharmacotherapy and outcomes science at Virginia Commonwealth University School of Pharmacy in Richmond.Results of two large outcome trials, REDUCE-IT and STRENGTH, will provide information on whether long-term prescription omega-3 fatty acids are beneficial in reducing cardiovascular events in patients with triglyceride values that are elevated at a level of 200 mg/dL to 499 mg/dL.Sisson said results from REDUCE-IT, which compare Vascepa plus statin to statin alone, will help determine if reducing non-HDL cholesterol by adding Vascepa to a statin further reduces residual cardiovascular risk.“Although well-designed studies may suggest off-label uses for drugs, many consumers are unable to accurately evaluate the quality of the data,” said Sisson. “In the absence of a formal FDA review, pharmacists must serve as an advocate for patient safety, critically reviewing the drug therapy literature and interpreting the information for the patient and their health care team.” (See sidebar.)Vascepa for off-label use: What do MTM pharmacists need to know?Omega-3 fatty acid products are used for many different off-label purposes, ranging from dermatologic to psychiatric.“They are used for so many ‘uses’ that it is hard to sometimes determine what they are being used for or if they are being perceived by a patient or clinician as effective,” said Saseen.Sisson added that although omega-3 fatty acids effectively lower triglyceride levels, monotherapy is appropriate only for patients with significantly elevated levels—greater than 500 mg/dL—who are at risk of pancreatitis.“To lower cardiovascular risk, omega-3 fatty acids should always be used in addition to background statin therapy,” said Sisson.Of course, diet, exercise, and other lifestyle changes are also key.Medication therapy management pharmacists are accustomed to off-label uses of certain medications, which is all the more reason they need to stay up to date with the literature and what’s FDA approved and not. Sites such as Micromedex and the New England Journal of Medicine’s Journal Watch can provide reliable information for pharmacists to keep up with patients’ questions. In a legal settlement that’s much talked about, FDA agreed to allow the drug company Amarin to market its prescription omega-3 fatty acid product for off-label use. Amarin’s icosapent ethyl (Vascepa) is FDA approved to treat extremely high triglyceride values of 500 mg/dL or above. Although physicians commonly prescribe the medication for off-label use, the agreement would allow Amarin to market Vascepa to patients with high triglyceride levels of 200 mg/dL to 499 mg/dL. Saseen also believes the decision could open a “floodgate” for other companies that are seeking to promote their prescription medications for off-label use. Other experts agree that the decision would signal to other drug companies that they may be able to negotiate with FDA. In 2015, Amarin sued FDA for the right to market Vascepa to a larger group of patients. The court ruled in Amarin’s favor and said prohibiting Amarin from disseminating truthful information about the medication was a violation of free speech. FDA decided not to appeal the judge’s ruling. The final settlement must still be approved by a federal judge. “Based on the unusual circumstances of this case and the scientific information known to the FDA at this time, the agency does not anticipate a substantial adverse impact on public health resulting from this agreement,” said FDA in a statement. FDA is encouraging health care providers to continue to use their best clinical judgment based on all available scientific information about use of Vascepa for individual patients. Many unknownsLike other omega-3 fatty acids, Vascepa provides a dose-dependent reduction in triglyceride levels. But much is still unknown about omega-3 fatty acids, and the mortality benefit of triglyceride reduction with Vascepa is unclear for patients with triglyceride levels less than 500 mg/dL, according to Evan Sisson, PharmD, associate professor in the department of pharmacotherapy and outcomes science at Virginia Commonwealth University School of Pharmacy in Richmond.Results of two large outcome trials, REDUCE-IT and STRENGTH, will provide information on whether long-term prescription omega-3 fatty acids are beneficial in reducing cardiovascular events in patients with triglyceride values that are elevated at a level of 200 mg/dL to 499 mg/dL.Sisson said results from REDUCE-IT, which compare Vascepa plus statin to statin alone, will help determine if reducing non-HDL cholesterol by adding Vascepa to a statin further reduces residual cardiovascular risk.“Although well-designed studies may suggest off-label uses for drugs, many consumers are unable to accurately evaluate the quality of the data,” said Sisson. “In the absence of a formal FDA review, pharmacists must serve as an advocate for patient safety, critically reviewing the drug therapy literature and interpreting the information for the patient and their health care team.” (See sidebar.)Vascepa for off-label use: What do MTM pharmacists need to know?Omega-3 fatty acid products are used for many different off-label purposes, ranging from dermatologic to psychiatric.“They are used for so many ‘uses’ that it is hard to sometimes determine what they are being used for or if they are being perceived by a patient or clinician as effective,” said Saseen.Sisson added that although omega-3 fatty acids effectively lower triglyceride levels, monotherapy is appropriate only for patients with significantly elevated levels—greater than 500 mg/dL—who are at risk of pancreatitis.“To lower cardiovascular risk, omega-3 fatty acids should always be used in addition to background statin therapy,” said Sisson.Of course, diet, exercise, and other lifestyle changes are also key.Medication therapy management pharmacists are accustomed to off-label uses of certain medications, which is all the more reason they need to stay up to date with the literature and what’s FDA approved and not. Sites such as Micromedex and the New England Journal of Medicine’s Journal Watch can provide reliable information for pharmacists to keep up with patients’ questions. Like other omega-3 fatty acids, Vascepa provides a dose-dependent reduction in triglyceride levels. But much is still unknown about omega-3 fatty acids, and the mortality benefit of triglyceride reduction with Vascepa is unclear for patients with triglyceride levels less than 500 mg/dL, according to Evan Sisson, PharmD, associate professor in the department of pharmacotherapy and outcomes science at Virginia Commonwealth University School of Pharmacy in Richmond. Results of two large outcome trials, REDUCE-IT and STRENGTH, will provide information on whether long-term prescription omega-3 fatty acids are beneficial in reducing cardiovascular events in patients with triglyceride values that are elevated at a level of 200 mg/dL to 499 mg/dL. Sisson said results from REDUCE-IT, which compare Vascepa plus statin to statin alone, will help determine if reducing non-HDL cholesterol by adding Vascepa to a statin further reduces residual cardiovascular risk. “Although well-designed studies may suggest off-label uses for drugs, many consumers are unable to accurately evaluate the quality of the data,” said Sisson. “In the absence of a formal FDA review, pharmacists must serve as an advocate for patient safety, critically reviewing the drug therapy literature and interpreting the information for the patient and their health care team.” (See sidebar.)Vascepa for off-label use: What do MTM pharmacists need to know?Omega-3 fatty acid products are used for many different off-label purposes, ranging from dermatologic to psychiatric.“They are used for so many ‘uses’ that it is hard to sometimes determine what they are being used for or if they are being perceived by a patient or clinician as effective,” said Saseen.Sisson added that although omega-3 fatty acids effectively lower triglyceride levels, monotherapy is appropriate only for patients with significantly elevated levels—greater than 500 mg/dL—who are at risk of pancreatitis.“To lower cardiovascular risk, omega-3 fatty acids should always be used in addition to background statin therapy,” said Sisson.Of course, diet, exercise, and other lifestyle changes are also key.Medication therapy management pharmacists are accustomed to off-label uses of certain medications, which is all the more reason they need to stay up to date with the literature and what’s FDA approved and not. Sites such as Micromedex and the New England Journal of Medicine’s Journal Watch can provide reliable information for pharmacists to keep up with patients’ questions. Vascepa for off-label use: What do MTM pharmacists need to know?Omega-3 fatty acid products are used for many different off-label purposes, ranging from dermatologic to psychiatric.“They are used for so many ‘uses’ that it is hard to sometimes determine what they are being used for or if they are being perceived by a patient or clinician as effective,” said Saseen.Sisson added that although omega-3 fatty acids effectively lower triglyceride levels, monotherapy is appropriate only for patients with significantly elevated levels—greater than 500 mg/dL—who are at risk of pancreatitis.“To lower cardiovascular risk, omega-3 fatty acids should always be used in addition to background statin therapy,” said Sisson.Of course, diet, exercise, and other lifestyle changes are also key.Medication therapy management pharmacists are accustomed to off-label uses of certain medications, which is all the more reason they need to stay up to date with the literature and what’s FDA approved and not. Sites such as Micromedex and the New England Journal of Medicine’s Journal Watch can provide reliable information for pharmacists to keep up with patients’ questions. Vascepa for off-label use: What do MTM pharmacists need to know?Omega-3 fatty acid products are used for many different off-label purposes, ranging from dermatologic to psychiatric.“They are used for so many ‘uses’ that it is hard to sometimes determine what they are being used for or if they are being perceived by a patient or clinician as effective,” said Saseen.Sisson added that although omega-3 fatty acids effectively lower triglyceride levels, monotherapy is appropriate only for patients with significantly elevated levels—greater than 500 mg/dL—who are at risk of pancreatitis.“To lower cardiovascular risk, omega-3 fatty acids should always be used in addition to background statin therapy,” said Sisson.Of course, diet, exercise, and other lifestyle changes are also key.Medication therapy management pharmacists are accustomed to off-label uses of certain medications, which is all the more reason they need to stay up to date with the literature and what’s FDA approved and not. Sites such as Micromedex and the New England Journal of Medicine’s Journal Watch can provide reliable information for pharmacists to keep up with patients’ questions. Omega-3 fatty acid products are used for many different off-label purposes, ranging from dermatologic to psychiatric. “They are used for so many ‘uses’ that it is hard to sometimes determine what they are being used for or if they are being perceived by a patient or clinician as effective,” said Saseen. Sisson added that although omega-3 fatty acids effectively lower triglyceride levels, monotherapy is appropriate only for patients with significantly elevated levels—greater than 500 mg/dL—who are at risk of pancreatitis. “To lower cardiovascular risk, omega-3 fatty acids should always be used in addition to background statin therapy,” said Sisson. Of course, diet, exercise, and other lifestyle changes are also key. Medication therapy management pharmacists are accustomed to off-label uses of certain medications, which is all the more reason they need to stay up to date with the literature and what’s FDA approved and not. Sites such as Micromedex and the New England Journal of Medicine’s Journal Watch can provide reliable information for pharmacists to keep up with patients’ questions.