Statement by Merck & Co., Inc., in Response to the FDA’s Update Regarding a Safety Review on Bisphosphonates including FOSAMAX® (alendronate sodium)
The FDA announced its update on the safety review of bisphosphonates, including FOSAMAX®, that found no clear association between overall bisphosphonate exposure and the rate of serious or non serious atrial fibrillation. Increasing dose or duration of bisphosphonate therapy was also not associated with an increased rate of atrial fibrillation. These findings are based on the Agency’s review of data from clinical studies of bisphosphonates. These findings are consistent with Merck’s extensive review of our FOSAMAX clinical trials and post-marketing pharmacovigilance data that were submitted to the Agency. Go to http://www.merck.com/newsroom/press_releases/product/2007_0502.html
for further detail on clinical studies with FOSAMAX.
As with all of its medicines, Merck regularly monitors adverse experiences with FOSAMAX in its clinical trials and post-marketing events and reports these events to regulatory agencies worldwide in accordance with domestic and international reporting regulations and safety guidelines.
Important Information about FOSAMAX
FOSAMAX like other bisphosphonate containing products, should be used with caution in people with certain stomach or digestive problems. FOSAMAX 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 up straight for at least 30 minutes. In addition, FOSAMAX 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 or in patients who are pregnant or nursing. Patients who have difficulty swallowing liquids should not take FOSAMAX oral solution.
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. FOSAMAX may cause Jawbone problems, may include infection, and delayed healing after teeth are pulled.
The standard dosing regimen for FOSAMAX 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, 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.
For more information on products containing FOSAMAX, please see and read the prescribing information and patient package insert which are available at www.fosamax.com.
This statement contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and 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 risk factors and cautionary statements in Item 1A of Merck’s Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company’s periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
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