Risedronate
Encyclopedia
Risedronic acid or risedronate sodium (USAN
) is a bisphosphonate
used to strengthen bone
, treat or prevent osteoporosis
, and treat Paget's disease
of bone. It is produced and marketed by Warner Chilcott
, Sanofi-Aventis
, and in Japan by Takeda
under the trade names Actonel, Atelvia, and Benet. It is also available in a preparation that includes a calcium carbonate supplement, as Actonel with Calcium.
, it can lead to esophageal ulcers
. Therefore, it is recommended that risedronate be taken with the body upright, and followed by a glass of water. Moreover, risedronate is poorly absorbed when taken with food, so it is recommended that no food or drink other than water be taken for 2 hours before and 30 minutes after taking risedronate. Risedronate has a faster esophageal transit time and different chemical chain which results in less gastrointestinal side-effects than other drugs in this class. The dosage instructions also show that risedronate can be taken with less water than other drugs in the class.
Risedronate is also available as a 75mg tablet to be taken on two consecutive days each month (2CDM) in order to optimize patient adherence. This formulation has been studied in a randomized, double-blind, parallel-group, multinational trial in 1229 postmenopausal women with osteoporosis.
filed a Lanham Act
false claims lawsuit against rival drugmakers Roche
and GlaxoSmithKline
claiming false advertising about Boniva
. The manufacturers of Boniva, a rival bisphosphonate, were accused in the suit of causing a "serious public health risk" through misrepresentation of scientific findings. In a ruling on September 7, 2006 U.S. District Judge Paul A. Crotty rejected P&G's attempted injunction. P&G was criticized for attempting to "preserve its market share by denigrating Boniva". Judge Crotty wrote that "Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented".
In 2006, P&G faced controversy over its handling of clinical research involving risedronate (News Reports and discussion).
In common with other bisphosphonate
drugs, risedronate appears to be associated with the rare side effect osteonecrosis of the jaw
, often preceded by dental procedures inducing trauma to the bone.
United States Adopted Name
United States Adopted Names are unique nonproprietary names assigned to pharmaceuticals marketed in the United States. Each name is assigned by the USAN Council, which is co-sponsored by the American Medical Association , the United States Pharmacopeial Convention , and the American Pharmacists...
) is a bisphosphonate
Bisphosphonate
Bisphosphonates are a class of drugs that prevent the loss of bone mass, used to treat osteoporosis and similar diseases...
used to strengthen bone
Bone
Bones are rigid organs that constitute part of the endoskeleton of vertebrates. They support, and protect the various organs of the body, produce red and white blood cells and store minerals. Bone tissue is a type of dense connective tissue...
, treat or prevent osteoporosis
Osteoporosis
Osteoporosis is a disease of bones that leads to an increased risk of fracture. In osteoporosis the bone mineral density is reduced, bone microarchitecture is deteriorating, and the amount and variety of proteins in bone is altered...
, and treat Paget's disease
Paget's disease
Sir James Paget, a surgeon and pathologist, described several diseases, including:* Paget's disease of bone * Paget's disease of the breast* Paget-Schroetter disease* Extramammary Paget's disease...
of bone. It is produced and marketed by Warner Chilcott
Warner Chilcott
Warner Chilcott is a pharmaceutical company based in Rockaway, New Jersey, USA. It has production and research facilities in Fajardo, Puerto Rico, Larne, Northern Ireland, Dundalk, Ireland and Weiterstadt, Germany. It is primarily focused on two core therapeutic areas: women’s healthcare and...
, Sanofi-Aventis
Sanofi-Aventis
Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
, and in Japan by Takeda
Takeda Pharmaceutical Company
is the largest pharmaceutical company in Japan and Asia and a top 15 pharmaceutical company. The company has over 19,000 employees worldwide and achieved $15.7 billion USD in revenue during the 2008 fiscal year...
under the trade names Actonel, Atelvia, and Benet. It is also available in a preparation that includes a calcium carbonate supplement, as Actonel with Calcium.
Administration
Risedronate is taken orally, usually weekly or monthly. Notably, if risedronate lodges in the esophagusEsophagus
The esophagus is an organ in vertebrates which consists of a muscular tube through which food passes from the pharynx to the stomach. During swallowing, food passes from the mouth through the pharynx into the esophagus and travels via peristalsis to the stomach...
, it can lead to esophageal ulcers
Peptic ulcer
A peptic ulcer, also known as PUD or peptic ulcer disease, is the most common ulcer of an area of the gastrointestinal tract that is usually acidic and thus extremely painful. It is defined as mucosal erosions equal to or greater than 0.5 cm...
. Therefore, it is recommended that risedronate be taken with the body upright, and followed by a glass of water. Moreover, risedronate is poorly absorbed when taken with food, so it is recommended that no food or drink other than water be taken for 2 hours before and 30 minutes after taking risedronate. Risedronate has a faster esophageal transit time and different chemical chain which results in less gastrointestinal side-effects than other drugs in this class. The dosage instructions also show that risedronate can be taken with less water than other drugs in the class.
Risedronate is also available as a 75mg tablet to be taken on two consecutive days each month (2CDM) in order to optimize patient adherence. This formulation has been studied in a randomized, double-blind, parallel-group, multinational trial in 1229 postmenopausal women with osteoporosis.
Controversies
In January 2006 P&G and its marketing partner Sanofi-AventisSanofi-Aventis
Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
filed a Lanham Act
Lanham Act
The Lanham Act is a piece of legislation that contains the federal statutes of trademark law in the United States. The Act prohibits a number of activities, including trademark infringement, trademark dilution, and false advertising.-History:Named for Representative Fritz G...
false claims lawsuit against rival drugmakers Roche
Hoffmann-La Roche
F. Hoffmann-La Roche Ltd. is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange....
and GlaxoSmithKline
GlaxoSmithKline
GlaxoSmithKline plc is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom...
claiming false advertising about Boniva
Ibandronic acid
Ibandronic acid or ibandronate sodium , marketed under the trade names Boniva, Bondronat and Bonviva, is a potent bisphosphonate drug used in the prevention and treatment of osteoporosis....
. The manufacturers of Boniva, a rival bisphosphonate, were accused in the suit of causing a "serious public health risk" through misrepresentation of scientific findings. In a ruling on September 7, 2006 U.S. District Judge Paul A. Crotty rejected P&G's attempted injunction. P&G was criticized for attempting to "preserve its market share by denigrating Boniva". Judge Crotty wrote that "Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented".
In 2006, P&G faced controversy over its handling of clinical research involving risedronate (News Reports and discussion).
In common with other bisphosphonate
Bisphosphonate
Bisphosphonates are a class of drugs that prevent the loss of bone mass, used to treat osteoporosis and similar diseases...
drugs, risedronate appears to be associated with the rare side effect osteonecrosis of the jaw
Osteonecrosis of the jaw
Osteonecrosis of the jaw is a severe bone disease that affects the maxilla and the mandible. Various forms of ONJ have been described over the last 160 years, and a number of causes have been suggested in the literature...
, often preceded by dental procedures inducing trauma to the bone.