Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
December 19, 2011
Health Canada has issued new restrictions concerning the use of alendronate. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Atypical femur fracture: There is evidence that long term use of this class of medication may contribute to a type of rare fracture of the long bone in the thigh (femur).
If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.
Bone, joint, and muscle problems: Rarely, people taking this medication experience severe bone, joint, or muscle pain. This is usually reversed when the medication is stopped.
Calcium and vitamin D: Calcium and vitamin D are important contributors to bone growth and strength. It may be necessary to take calcium or vitamin D supplements to get the best effect from alendronate if you are not getting enough from your diet. Your doctor may test you for low calcium levels or vitamin D deficiency before you start taking alendronate.
Effects on the esophagus: Alendronate may irritate the lining of the esophagus (the passage from the throat to the stomach). Esophagitis, ulcers, and erosions have been reported by people who take alendronate. In some cases, these effects have been severe and have required hospitalization. Contact your doctor at once if you suddenly experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn.
To ease the passage of the medication to the stomach and thus reduce the potential for irritation of the esophagus, swallow alendronate with a full glass of plain water upon arising for the day. Do not lie down until 30 minutes have passed and you have eaten your first food of the day. Do not chew or suck on the tablet, as this may lead to ulcers in the mouth or throat. Do not take alendronate at bedtime or before getting up for the day.
Effects on the stomach and intestines: Rarely, people taking this medication have developed ulcers of the stomach or intestines. If you suffer from stomach problems, such as ulcers and severe indigestion, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Get immediate medical attention if you have symptoms of a stomach or intestinal ulcer, such as nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood.
Jaw problems: Rarely, alendronate may cause severe jaw problems associated with delayed healing and infection, especially in people with cancer or after tooth extractions. If you experience any pain in the jaw, especially after having a tooth removed, contact your doctor immediately.
Kidney function: Alendronate is removed from the body by the kidneys. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if alendronate passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children and adolescents: The safety and effectiveness of using this medication have not been established for children under 18 years of age.