Fosamax – FDA information
Fosamax is the brand name of the drug that has alendronate sodiumin it. It is also classified as a bisphosphonate and acts as a specific inhibitor of osteoclast-mediated bone resorption. Being synthetic analogs of pyrophosphate, bisphosphonates bind to the hydroxyapatite found in bone.
Due to a rising number of claims that some drugs in the market can be responsible for several serious side effects, an agency called The Food and Drug Administration (FDA), in order to ensure public health and safety is monitoring the potential side effects of popular drugs. Fosamax with some other drugs Aredia and Zomenta have made some buzz for quite some time. The claims made against these drugs have been significant enough for FDA to issue a warning for using these drugs: The warning is published on the official fda website at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm
On September 24, 2004 a letter was sent to oncologists, dentists, and other healthcare professionals, informing them about Novartis’ Zometa and its severe dental side effects. Less than a year later, another warning, this time against Aredia, was delivered to the medical and healthcare experts. Aredia is also a bisphosphonate manufactured by Novartis.
In 2005 alone, doctors wrote 22.4 million prescriptions for Fosamax knowing that each one of these people taking this drug could potentially suffer the misery of osteonecrosis of the jaw.
You need to consult with a compassionate and experienced attorney immediately if you or someone you know developed this devastating condition due to Fosamax. You may not be able to take legal action against those responsible for your agonizing condition, but you could be get a financial compensation package for your physical pain and emotional suffering.
Latest updates on the Warning and Precaustions section of bisphophonates were made by FDA in October, 2010. The drugs included Fosamax, manufactured by Merck. The warning came after experts found a link between the usage of the drug and the continuous bone fractures by the users. It results in various other health problems but the rate of unusual fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures are too high to be ignored. Reports also suggest that the drug also causes osteonecrosis, a disfiguring condition caused by the rotting of the jaw. Merck & Co. has had to defend a flood of lawsuits for the last five years filed by osteonecrosis victims.
Drug Name(s): FOSAMAX (Brand Name Drug)
FDA Application No.: (NDA) 020560
Active Ingredient(s): ALENDRONATE SODIUM
Company: MERCK AND CO INC
Original Approval or Tentative Approval Date: September 29, 1995
Chemical Type: 1 New molecular entity (NME)
Review Classification: P Priority review drug
Other reactions which can be called severe include nausea, heartburn, stomach pain, diarrhea, muscle cramps, blood clotting disorders, numbness and seizures. After medical trials the drug reported mild side effects, hence it was approved by FDA in 1995. But today the side effects of Fosamax are too much to call ‘mild’ as it can cause an irreversible loss like jaw decay. Therefore FDA has instructed all physicians to hand a medication guide to their patients which explains recent findings about Fosamax’s side effects.
A possible side effect of Fosamax Plus D is fracture in a specific part of the thigh bone. It is advisable, rather must, to call your doctor if you develop new or unusual pain in the hip or thigh.