On January 12, 2020, the United States Food and Drug Administration (FDA) will be giving final approval to to raise prescription drug dosages for adults with systolic blood pressure of 130 to 139 millimetres of mercury or less (mmHg). The FDA also mandated that written prescriptions be able to vary in doses for adults with systolic blood pressure of 140 mmHg and higher.
Patients and public health advocates have long been calling for expanded access to lowering blood pressure to help adults with such high blood pressure (HDL, systolic, and diastolic) reach those proposed targets. This year marks a milestone in the journey of lowering hypertension in the United States that has engaged pharmaceutical research, regulation, and prevention, and the FDA has responded in a meaningful way by implementing options for patients who wish to take a different dose of drugs to lower blood pressure.
Adults with untreated high blood pressure can have a significant health burden. By having a higher elevated blood pressure, they run a higher risk of kidney disease and other cardiovascular health issues. As such, with the potential of lowering hypertension blood pressure, the FDA has permitted individualized medication therapy to reduce blood pressure in both adults and adults with diabetes who do not reach target blood pressure and plan to take one or more medications to meet those targets.
A number of advances are helping to change the standard of care for the treatment of high blood pressure in adults and reduce the barriers to obtaining and maintaining effective treatment. Even though the United States lags significantly behind many other countries in the treatment of high blood pressure, and adoption of the latest treatment strategies in adults with high blood pressure may be especially slow, innovations for medications and drug dosages have been advancing rapidly. In the past few years, the FDA has supported these innovations, as well as groundbreaking scientific information about how to manage blood pressure disorders such as atherosclerosis.
Reducing blood pressure in adults with hypertension was recommended by the World Health Organization’s guidelines in 2015. Although some older adults with untreated high blood pressure may have liver damage, angina, and some other serious health problems associated with high blood pressure, most will experience improved health outcomes over the course of a lifetime through improved blood pressure control.
The release of the finalized ESR and the launch of Notice of Proposed Rulemaking (NPRM) facilitates the expansion of access to injectable, subcutaneous (under the skin), and oral blood pressure lowering medications. Injectable and subcutaneous medication options, such as Januvia and Byetta, provide an opportunity for more optimal blood pressure control for patients with type 2 diabetes and other risk factors for high blood pressure. These types of drugs also have a shorter convenience time, providing an additional convenience factor for people who are trying to reduce blood pressure. The oral option, Signacon, is similar to a minibar by providing a package of lifestyle changes for adults with hypertension, which will help reduce blood pressure, improve weight, and lower cholesterol.
The FDA has targeted new options and choices for adults with uncontrolled hypertension, all while strengthening our existing standards for the management of high blood pressure. The FDA plans to increase awareness among doctors and patients about the options, as well as provide information and guidance to help get the right treatment for everyone.
The FDA’s announcement of four new therapies to reduce high blood pressure coincides with the launch of a major public education and awareness campaign for adults with high blood pressure. Supported by a partnership between the FDA and the National Heart, Lung, and Blood Institute, the campaign will provide clinical information and tools to patients and their doctors that promote ways to become more physically active and eat healthy.