FDA approves FOSAMAX PLUS D for Osteoporosis

Main Category: Bones / Orthopaedics
Article Date: 12 Apr 2005 - 14:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Merck & Co, Inc. announced today that the US Food and Drug Administration (FDA) has approved FOSAMAX PLUS DTM -

(alendronate sodium/cholecalciferol), a single once-weekly tablet containing 70 mg FOSAMAX® (alendronate sodium) and 2800 IU vitamin D3, representing 7 days worth of 400 IU of vitamin D. (The recommended intake of vitamin D is 400-800 IU daily). FOSAMAX has been demonstrated to reduce the risk of both hip and spine fractures in postmenopausal women with osteoporosis and is now the only bisphosphonate with the added benefit of a weekly dose of vitamin D.

"The approval of FOSAMAX PLUS D is important news for women diagnosed with osteoporosis," said Dr. Robert Heaney, Professor of Medicine, Creighton University. "This product will provide physicians with an important new option providing the well documented clinical benefit of FOSAMAX with the added advantage that those patients taking it are receiving a weekly dose of vitamin D. Having a product like FOSAMAX PLUS D available to help physicians better manage vitamin D nutrition in their patients should be welcomed news for the estimated 10 million Americans who have osteoporosis and the physicians who treat them."

Maintaining adequate levels of vitamin D is necessary for the development of strong bones because it helps increase the intestinal absorption of calcium. Vitamin D insufficiency is associated with reduced calcium absorption, bone loss, and increased risk of fracture. Patients at increased risk for vitamin D insufficiency (e.g. those who are nursing-home bound, chronically ill, over the age of 70 years) and with gastrointestinal malabsorption syndromes should receive vitamin D supplementation in addition to that provided in FOSAMAX PLUS D.

FOSAMAX PLUS D provides the proven power of FOSAMAX, the world's most prescribed osteoporosis medication[1]

FOSAMAX PLUS D provides the proven power of FOSAMAX, the world's most prescribed osteoporosis treatment, which has been demonstrated to significantly reduce the risk of both osteoporotic hip and spine fractures. The sustained efficacy of FOSAMAX for the treatment of osteoporosis in postmenopausal women was demonstrated in a trial that found in over 10 years of therapy FOSAMAX 10 mg once daily maintained or continued to build bone.

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.

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 severe kidney disease or low levels of calcium in their blood, in patients who are allergic to FOSAMAX PLUS D or in patients who are pregnant or nursing. FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.

The catalog price of FOSAMAX PLUS D will be equivalent to the price of FOSAMAX 70 mg tablets.

Many women are unaware of the importance of vitamin D

"Many physicians and patients frequently are unaware of the importance of vitamin D in bone health. Given its effect on calcium absorption, vitamin D insufficiency is an important medical concern for patients with osteoporosis, as it can lead to bone loss and an increased risk of fracture," said Dr. Robert Heaney.

Vitamin D is obtained from two sources: sunlight and diet. 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. Vitamin D can also come from the diet but there are limited dietary sources that contain the nutrient. Good dietary sources include fatty fish (e.g., salmon), vitamin D fortified milk and orange juice. However, for many people, dietary sources alone are not enough. For example, one must drink four 8 ounce glasses of milk to receive 400 IU of vitamin D.

Women, 51 and older, 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 are not consuming enough vitamin D. The study estimated that over 70% of women age 51-70 and almost 90% of women over 70 are not getting an adequate intake of vitamin D from food and supplements. This analysis was based on the adequate intake, as defined by the National Institute of Health's Institute of Medicine, of 400 IU per day for women age 51-70 and 600 IU per day for women over 70 years. Other organizations, such as the National Osteoporosis Foundation (NOF), recommend vitamin D intake of up to 800 IU per day. As a treatment for osteoporosis in postmenopausal women, FOSAMAX PLUS D offers 2800 IU vitamin D, representing 7 days worth of 400 IU of vitamin D.

Additional important information about FOSAMAX PLUS D

Patients should talk to their doctor if they have or have had problems with swallowing. In addition, patients should talk to their doctor if they have conditions which may cause an overproduction of vitamin D (e.g. sarcoidosis, leukemia, lymphoma). Patients should tell their doctor about all medicines they are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. The risk of severe esophageal 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%), musculoskeletal pain (2.9%), indigestion (2.7%), regurgitation (1.9%) and nausea (1.9%).

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.

About osteoporosis

Osteoporosis, the most prevalent bone disease in the U.S., 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. Most often, it is 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, osteoporosis is a national health threat and by 2020 one in two Americans over the age of 50 will be at risk for fractures from osteoporosis or low bone mass. 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.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in over 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K which the company incorporates by reference.

Full prescribing information for FOSAMAX PLUS D™ is available at 1-800-344-7833 and the patient product information is also available at 1-800-546-8173.