Actonel Side Effects Lawsuit

Actonel Side Effects Lawsuit

Actonel Side Effects Lawsuit 

Actonel is risedronate sodium tablets used for the treatment of osteoporosis.

Risedronate sodium is a white and odorless fine crystalline powder that is soluble in water and aqueous solutions. It is insoluble essentially in common organic solvents. All dose strengths include the following inactive ingredients:

  • Crospovidone
  • Hydroxypropyl Cellulose
  • Hypromellose
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Polyethylene Glycol
  • Silicon Dioxide
  • Titanium Dioxide

The dose strength-specific ingredients are as follows:

  • 5mg ferric oxide yellow, lactose monohydrate
  • 30mg lactose monohydrate
  • 35mg ferric oxide red/ ferric oxide yellow lactose monohydrate
  • 75mg ferric oxide red
  • 150mg FD&C blue no. 2 aluminum lake
 Actonel possesses an affinity for hydroxyapatite crystals in bone and it acts an antiresorptive agent. Actonel inhibits osteoclasts at cellular level that hold normally to the bone surface but show evidence of reduced active resorption.
Used for the treatment of osteoporosis in postmenopausal women, Actonel reduces the commonness of vertebral fractures and a compound endpoint of nonvertebral osteoporosis-related fractures. For men with osteoporosis, Actonel is used for treatment to increase bone mass.
Actonel is used, in both men and women who are starting or continuing systemic glucocorticoid treatment, for the prevention and treatment of glucocorticoid-induced osteoporosisand is also used to treat Paget’s disease of bone in both men and women.

Actonel is to be taken at least 30 minutes before the first intake of food or drink, excluding water, during the day with a full glass of water and patients should not lie down for 30 minutes after taking the medication. If it is inadequate for the patient to intake food, supplemental calcium and vitamin D should be received but if received, Actonel should be taken at a different time of day for the calcium supplement may interfere with the absorption of the medication.

For treatment of Postmenopausal Osteoporosis in women the following regimen is recommended:
  • One 5mg tablet orally-taken daily
  • One 35mg tablet orally-taken once a week
  • One 75mg tablet orally- taken on two consecutive day in each month
  • One 150mg tablet orally- taken once a month

For treatment to increase bone mass in men the following regimen is recommended:

  • One 35mg tablet orally-taken once a week

For treatment of Paget ’s disease the following regimen is recommended:

  • One 35mg tablet orally-taken once daily for two months

In a multinational trial of Actonel which included 3232 women, ages 38 to 85, taking 5mg Actonel once daily, the incidence of serious adverse side effects was plentiful. The Gastrointestinal adverse events included abdominal pain (12.2%), diarrhea (10.8%), dyspepsia (10.8%), and gastritis (2.7%). Glossitis and duodentis have also been uncommonly reported (0.1%-1%). The Musculoskeletal side effects included back pain (28%), arthralgia (23.7%), myalgia (6.7%), and bone pain (5.3%)

Actonel and other bisphosponates can cause upper gastrointestinal disorders including esophagitis, dysphagia, and esophageal or gastric ulcers. Dosing instructions should be followed to reduce the risk of side effects.

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