FDA Approves New Dosage Strength of FOSAMAX PLUS D (alendronate sodium/cholecalciferol), Increasing Vitamin D Intake for Patients with Osteoporosis

New Dose Supports National Osteoporosis Foundation Call for Older Americans to Take More Vitamin D

WHITEHOUSE STATION, N.J., - Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new dosage of FOSAMAX PLUS D™ (alendronate sodium/cholecalciferol), a single, once-weekly tablet containing FOSAMAX® (alendronate sodium) 70 mg and 5,600 international units (IU) of vitamin D3 (cholecalciferol).

“This once-weekly medicine now contains both the well-documented fracture benefits of FOSAMAX as well as 5,600 IU of vitamin D3. This provides physicians with another option to manage their osteoporotic patients, many of whom are not getting enough vitamin D3,” said Robert Heaney, M.D., professor of medicine, Creighton University, Omaha, Nebraska. “The importance of vitamin D3 for postmenopausal women with osteoporosis has been recently highlighted by the updated recommendation from the National Osteoporosis Foundation (NOF) for increased vitamin D intake.”

NOF calls for increased vitamin D intake for Americans over 50
The NOF recently updated its recommendations for calcium and vitamin D intake, advocating for 800-1,000 IU of vitamin D3 per day for adults over 50. Consistent with these recommendations, FOSAMAX PLUS D (70 mg alendronate/5,600 IU vitamin D3) is now the appropriate dose for most postmenopausal patients with osteoporosis being treated with FOSAMAX PLUS D. Patients at increased risk for vitamin D deficiency (e.g., those who are nursing-home bound, chronically ill, over the age of 70 years) or with gastrointestinal malabsorption syndromes may require vitamin D supplementation in addition to that provided in FOSAMAX PLUS D (70 mg/5,600 IU).

FOSAMAX PLUS D is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, FOSAMAX PLUS D increases bone mass and reduces the incidence of fracture, including those of the hip and spine. FOSAMAX PLUS D is also indicated to increase bone mass in men with osteoporosis. It is the only bisphosphonate with a weekly dose of vitamin D3, as per the NOF guidelines.

FOSAMAX PLUS D, like other bisphosphonate containing products, should be used with caution in people with certain stomach or digestive problems. FOSAMAX PLUS D should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes. In addition, FOSAMAX PLUS D should not be used in patients with low levels of calcium in their blood or in patients who are allergic to FOSAMAX PLUS D, and is not recommended for use in patients with severe kidney disease or in patients who are pregnant or nursing. FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.

Nearly two out of three women over 50 are not getting enough vitamin D
According to an analysis published in 2004 and based on the Third National Health and Nutrition Examination Survey (NHANES III), a majority of Americans do not receive enough vitamin D. The analysis estimated that over 70 percent of women age 51-70 and almost 90 percent of women over 70 are not getting an adequate intake of vitamin D from food and supplements.

“It is clear that adequate levels of vitamin D are required for normal bone formation and most patients with osteoporosis need to find ways to get more,” added Dr. Heaney.

Benefits of vitamin D
Maintaining adequate levels of vitamin D is necessary for the development of strong bones because it helps increase the intestinal absorption of calcium. Low levels of vitamin D are associated with reduced calcium absorption, bone loss, and increased risk of fracture.

The skin manufactures the majority of the body’s vitamin D after direct exposure to sunlight but as adults age, the ability to make vitamin D through the skin diminishes. Avoiding sun exposure or using sunscreen can also limit a person’s production of vitamin D. There are limited dietary sources that contain vitamin D including fatty fish (e.g., salmon), and some brands of milk and orange juice that are fortified with small amounts of vitamin D. However, for many people, dietary sources alone are not enough. For example, one must drink four eight-ounce glasses of milk to deliver just 400 IU of vitamin D.

About osteoporosis
Osteoporosis is a major public health threat and the most prevalent bone disease that can lead to bone loss and an increased risk of fractures. Over 10 million Americans over the age of 50 have osteoporosis and another 34 million have low bone mass. Osteoporosis is especially common in women after menopause, but also occurs in older men. It is most often due to an increase in the rate of resorption (breakdown) of bone tissue that is not matched by the rate of bone formation. The risk of having an osteoporosis-related fracture increases with age. According to the Surgeon General, one in two Americans over the age of 50 will be at risk for fractures from osteoporosis or low bone mass by 2020 unless they make changes to their diet and lifestyle. In fact, one out of every two women over age 50 will have an osteoporosis-related fracture in their remaining lifetime, with the risk of fracture increasing with age.

Additional important information about FOSAMAX PLUS D
Patients should talk to their doctor if they have or have had problems swallowing. In addition, patients should talk to their doctor if they have conditions which may cause changes in vitamin D metabolism (e.g., sarcoidosis, leukemia, lymphoma). Vitamin D supplementation may worsen hypercalcemia and/or hypercalciuria in such patients and their urine and serum calcium should be monitored. Patients should tell their doctor about all medicines they are taking, including prescription and non-prescription medicines, vitamins and herbal supplements. These include calcium supplements, antacids, aspirin, non-steroidal anti-inflammatory drugs, olestra, mineral oils, orlistat, bile acid sequestrants, anticonvulsants, cimetidine and thiazides.

Some patients may develop severe digestive tract reactions including irritation, inflammation or ulceration of the esophagus. The risk of severe esophageal adverse experiences appears to be greater in patients who fail to follow dosing instructions (see prescribing information for more details). Patients who experience new or worsening heartburn, difficulty or pain when swallowing or chest pain should stop taking the drug and call their doctor right away. Patients who develop severe bone, joint, and/or muscle pain at any time should contact their doctor. The most commonly reported side effects with FOSAMAX in clinical studies have been abdominal pain (3.7 percent), musculoskeletal pain (2.9 percent), indigestion (2.7 percent), regurgitation (1.9 percent) and nausea (1.9 percent).

The standard dosing regimen for FOSAMAX PLUS D includes swallowing the tablet with six to eight ounces of plain water the first thing upon arising for the day and at least 30 minutes before the first food, beverage or medication of the day. After swallowing FOSAMAX PLUS D, patients should not lie down for at least 30 minutes and not until after consuming their first food of the day. Patients should not chew or suck on a tablet of FOSAMAX PLUS D.