Fosamax Alert! Dangerous Side Effects

Fosamax Alert! Dangerous Side Effects

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When a product enters the mainstream market, many people assume, and reasonably so, that such a product would have undergone sufficient testing. However, oftentimes a drug will be placed on the market before that drug has been tested properly. Since testing measures often are inadequate, manufacturers find themselves forced to change the drugs label warnings often, usually on the insistence of the FDA. It is questionable whether manufacturers of such drugs would voluntarily change such labels, if not asked to do so by the FDA, as to avoid any controversy or public backlash as to inadequacies on the drugs initial label warnings.
Consumers are harmed when drug manufacturers fail to thoroughly test drugs, and, in doing so, fail to place warnings on the drugs labels which adequately reflect a particular drugs risks. The medication Fosamax is a prime example of manufacturers failure to ensure that a drugs safety requirements are reflected in drug label warnings before the drug is placed on the U.S. market.
Fosamax is in a class of drugs known as bisphosphonates, which are used to increase bone mass and reduce bone fractures. Oral bisphosphonates commonly are prescribed to prevent or treat osteoporosis in postmenopausal women. Bisphosphonates may be prescribed in tablet form such as Fosamax, or as intravenous bisphosphonates such as Zometa and Aredia. Fosomax is manufactured by Merck, and was approved by the FDA in 1995. However, in March 2010, the FDA announced that it would be investigating a possible link between the drug Fosamax (alendronate), and a particular type of leg fracture.
It recently has been discovered that Fosamax side effects include an increased risk of developing atypical fractures of the thigh in patients taking the drug will. Such atypical fractures, which include atypical subtrochanteric femur fractures- fractures in the bone just below the hip joint, and diaphyseal femur fractures- fractures occurring in the long part of the thigh bone, are associated with Fosamax and bisphosphonates generally. These types of fractures are very uncommon and are estimated to account for less than 1% of all hip and femur fractures overall. It is shocking that this drug has been on the market for over fifteen years, and yet this very serious risk of bone fractures was never reflected on the drugs safety label.
On October 13, 2010, the U.S. Food and Drug Administration (FDA) announced that it would require new warnings to be placed on the labels of bisphosphonates including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast. The label changes will reflect the increased risk of atypical fractures of the thigh associated with bisphosphonates.
Because of the inadequacy in these manufacturers testing procedures and, consequentially, inadequacy in warning labels, the FDA has had to take stringent measures by alerting the public of this increased risk of femur fractures through alterations to the drugs labels. Consumers should have been warned of these serious risks of fractures over fifteen years ago, when the drug Fosamax first entered the market.
Due to manufacturers, including Mercks, shortcomings in discovering any risks associated with Fosamax and other bisphosphonates medications, the public has suffered. Consumers and patients who decided to take the drug may have declined to take the drug had they known the manner in which their health and safety was at risk because of the drugs side effects.
Consumers and patients should have the information necessary to make meaningful medical decisions with their physicians. Failing to keep a watchful eye over drug manufacturers gives such manufacturers too much freedom to make inadequate labeling decisions thereby placing the health of patients at risk. A slap on the wrist through the FDA by implementing drug label changes is not enough to vindicate the rights of patients who have been harmed by large drug manufacturers. Safety testing procedures must be made more thorough. It is vital that medication safety labels reflect a medications risks from the moment a particular drug enters the mainstream U.S. market. Ensuring adequate safety labels will help to safeguard consumers and patients well being.

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