(RxWiki News) The US Food and Drug Administration (FDA) has approved a novel prescription weight management device.
This device is found under the name Plenity. The FDA approved it to help with weight management in adults who are overweight or obese, meaning those who have a body mass index (BMI) of 25 to 40. This new approval is to be used in combination with diet and exercise.
Plenity contains hydrogel particles. It's the first and only approved product made from cellulose and citric acid for weight management.
Here's how this prescription device works to help with weight management: The hydrogel particles expand in the stomach and make you feel full. Plenity absorbs the water you drink and mixes with the food you eat to make you feel full. As a result, you should feel the need to eat less.
The cellulose and citric acid create a 3-D hydrogel matrix. The capsules release thousands of particles that quickly absorb water in the stomach to make small gel pieces. All of these processes come together to make you feel full.
This product is to be taken with water twice a day (20 to 30 minutes before lunch and dinner). It is to be taken with 16 ounces of water. Common side effects include fullness, bloating, gas and stomach pain.
This weight management product may not be for everyone. Women who are pregnant and those who have an allergy to cellulose, citric acid, sodium stearyl fumarate, gelatin or titanium oxide are not candidates for Plenity.
Plenity has to be used with caution in those with stomach problems like gastroesophageal reflux disease (GERD), ulcers or heartburn.
Plenity can affect how the body absorbs medications that are to be taken at the same time. Your health care provider will tell you if you need to adjust the timing of your medications in relation to when you take Plenity.
Plenity will only be available through a prescription. It is not yet available. The biotechnology company Gelesis produces Plenity.
Written By Anyssa Garza, PharmD, BCMAS