bannerHON
img
HONnews
HONnews
img PATIENT / PARTICULIER img PROFESSIONNEL DE SANTE img WEBMESTRE img
img
 
img
HONcode sites
Khresmoi - new !
HONselect
News
Conferences
Images

Themes:
A B C D E F G H I
J K L M N O P Q
R S T U V W X Y Z
Browse archive:
2017: D N O S A J J M A M F J
2016: D

 
  Other news for:
Diabetes Mellitus
Diabetes Mellitus, Non-Insulin-Dependent
 Resources from HONselect
Diabetes Drug Gets FDA Warning Due to Amputation Risk
Canagliflozin tied to a doubling of amputations of legs, feet, agency says

By Robert Preidt

WEDNESDAY, May 17, 2017 (HealthDay News) -- The type 2 diabetes prescription drug canagliflozin (brand names Invokana, Invokamet, Invokamet XR) appears to increase the risk of leg and foot amputations, the U.S. Food and Drug Administration now says.

The FDA is requiring the medications to carry new warnings about the risk. The required warnings on the drug's labeling include the most serious and prominent boxed warning.

The agency's decision is based on data from two large clinical trials showing that leg and foot amputations occurred about twice as often in patients taking canagliflozin as among those taking a placebo.

Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred. Some patients had more than one amputation, some had amputations involving both limbs, according to the FDA.

Type 2 diabetes occurs when the body becomes resistant to insulin. Insulin is a hormone that helps to usher sugar from foods into the body's cells. When this process doesn't work correctly, blood sugar levels rise. Left untreated, high blood sugar levels can cause a number of possible complications, including heart disease, kidney problems and amputations, according to the American Diabetes Association.

Canagliflozin is meant to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These drugs lower blood sugar levels by causing the kidneys to remove sugar from the body through the urine.

It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

Patients taking canagliflozin should immediately notify their health care providers if they develop new pain or tenderness, sores or ulcers, or infections in the legs or feet, the FDA said in a news release. Patients should not stop taking their medication without first talking to their health care provider.

Before prescribing canagliflozin to patients, doctors should consider factors that may predispose patients to the need for amputations, including a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers, the FDA said.

In addition, doctors should monitor patients taking canagliflozin for the above signs and symptoms, and discontinue canagliflozin if these complications occur.

More information

The American Diabetes Association has more on diabetes complications.

SOURCE: U.S. Food and Drug Administration, news release, May 16, 2017

Copyright © 2017 HealthDay. All rights reserved. URL:http://consumer.healthday.com/Article.asp?AID=722790

Resources from HONselect: HONselect is the HON's medical search engine. It retrieves scientific articles, images, conferences and web sites on the selected subject.
Amputation
Risk
Blood
Health Personnel
Ulcer
Association
Specialty Chemicals and Products
The list of medical terms above are retrieved automatically from the article.

Disclaimer: The text presented on this page is not a substitute for professional medical advice. It is for your information only and may not represent your true individual medical situation. Do not hesitate to consult your healthcare provider if you have any questions or concerns. Do not use this information to diagnose or treat a health problem or disease without consulting a qualified healthcare professional.
Be advised that HealthDay articles are derived from various sources and may not reflect your own country regulations. The Health On the Net Foundation does not endorse opinions, products, or services that may appear in HealthDay articles.


Inicio img Sobre nosotros img Rincón de la prensa img Boletín HON img Mapa del sitio img Política ética img Contactos