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 Actonel DR® (risedronate delayed-release). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Effects on the esophagus and stomach: Risedronate delayed-release may irritate the lining of the esophagus (the tube that connects the mouth and the stomach) and the stomach.
Esophagitis (inflammation of the esophagus lining), ulcers, and erosions have been reported by people who take risedronate delayed-release. To ease the passage of the medication to the stomach and thus reduce the risk of irritation of the esophagus, swallow risedronate delayed-release with at least 120 mL (4 ounces) of plain water with breakfast. Do not lie down for at least 30 minutes after taking the tablet.
If you experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn, stop taking this medication and contact your doctor.
Jaw problems: Some people taking this type of medication have developed a type of jaw problem called osteonecrosis of the jaw. This is more likely to occur if you have dental surgery, have cancer, are receiving chemotherapy or corticosteroids (e.g., prednisone), or already have dental health problems. It is important to practice good mouth care during treatment with this medication. Talk to your doctor to find out whether you might be at risk. Your doctor may ask you to see your dentist before you start this medication.
Kidney function: Risedronate may not be removed from the body at the expected rate if the kidneys are not working properly. This increases the risk of side effects for the person taking this medication. 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.
If you have severely reduced kidney function, you should not take risedronate delayed-release.
Low calcium levels or vitamin D deficiency: Risedronate delayed-release may lower the calcium levels in your blood. If you have low blood calcium before you start taking this medication, it may get worse during treatment. Your low blood calcium must be treated before you take this medication. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms.
Call your doctor right away if you have symptoms of low blood calcium such as spasms, twitches, or cramps in your muscles; or numbness or tingling in your fingers, toes, or around your mouth.
Your doctor may prescribe or suggest that you take calcium and vitamin D to help prevent low calcium levels in your blood, while you take risedronate delayed-release.
Musculoskeletal pain: Severe bone, muscle, and joint pain have been reported by some people taking this medication. If you experience any severe symptoms, talk to your doctor about whether you should continue taking this medication.
Other risedronate products: Do not take this medication if you are already taking a medication than contains risedronate.
Thigh bone fractures: Some people have developed fractures with little or no trauma in their thigh bone while taking this or similar medications. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh. Call your doctor immediately if you have these symptoms.
Vision issues: Some people have developed inflammation of the eye after taking this or similar medication. If you develop any issues with your eye or vision, call your doctor immediately.
Pregnancy: Risedronate delayed-release is not intended to be taken by pregnant women and has not been studied for use by pregnant women.
Breast-feeding: Risedronate delayed-release is not intended to be taken by breast-feeding women. It is not known if risedronate passes into breast milk.
Children: The safety and effectiveness of this medication have not been established for children.