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Women who have gone through menopause are at a higher risk of developing osteoporosis as they age.  Boniva is a medication that has been prescribed to women in order to help increase their bone mass and prevent a fracture of the spine. Boniva is marketed both as a treatment for osteoporosis and as a means of preventing new cases. However, Boniva has also been associated with some severe side effects, including jaw fractures, femur bone fracture and other bone fractures. The side effects of Boniva are a serious matter. Ibandronate side effects cannot be simply be ignored. As a result, there have been numerous lawsuits against the manufacturer of this particular class of drugs, some of which have resulted in financial recoveries for the plaintiffs. If you have taken Boniva and have suffered any of these fractures, you should immediately contact a Boniva lawsuit attorney to see if you may be eligible for  Boniva side effects compensation. Many people are searcing the internet for the following,: “boniva vs fosamax” as well as “broken femur bone.”

What is Boniva?

Boniva medication was approved by the FDA to treat osteoporosis in 2003. The drug was designed and manufactured by Roche’s Genentech unit. In 2012, several different generic manufacturers received approval to make the drug after Genentech’s patent expired.

what is Boniva is an important question. Boniva can be taken in the tablet form or as an injection. The injections are given every three months and can mean that the patient does not have to take pills daily.  However, there have been shortages over the years of the injectable version. The drug has been a big contributor to Genentech’s bottom line. In 2011, the year before generic companies obtained approval to make the drug, sales of Boniva reached almost $500 million. The year before, sales reached nearly $1 billion. Genentech relied on a marketing blitz for the drug, setting aside a large budget for an ad campaign that featured actress Sally Field.  After generic versions of the drug were approved, sales levelled off for the drug.

What is Osteoporosis?

Bones continuously break down and re-form themselves. It is part of the normal process. However, when one suffers from osteoporosis, the bones break down and lose mass and they are not able to regrow. Osteoporosis can result from any one of a number of different conditions including rheumatoid arthritis or kidney and stomach conditions. Sometimes, osteoporosis simply comes from age. Those who have the condition suffer from issues with posture and are more likely to suffer bone breaks and femur bone fracture. There are over $20 billion in costs every year that are associated with osteoporosis.

How Boniva Works

Boniva ( ibandronate) medication works to prevent bone breakdown and to increase bone density. Specifically, it is known as Ibandronate. It is taken by tablet once every month. It contains nitrogen and prevents osteoclast-mediated bone resorption. In plain English, this is the process whereby cells break down the tissue in bones. The calcium from the tissue is then released into the bloodstream.  Boniva is supposed to increase the mass of the bones. Specifically, Boniva attempts to slow the process of bone breakdown and reformation since those who suffer from osteoporosis do not reform bone mass as well.

Boniva is a class of bisphosphonates. These substances are also found in laundry soaps and fertilizers. Bisphosphonates have also been used to treat certain types of cancer. Bisphosphonates work by binding to calcium ions, and the only place in the body where calcium is found in great supply is in the bones.

Side Effects of Boniva

what are the ibandronate side effects? While Boniva is intended to help strengthen the bones and prevent loss of bone density, in practice it can actually lead to bone fractures among people who are taking the drug. Specifically, the femur bone is at increased risk of fracture. This began to be noticed by researchers several years after the drug received FDA approval.  Some researchers have expressed concern that Boniva can help delay the reformation process while the bone breakdown is still occurring.

This has been the subject of an FDA communication that was issued in October 2010.  The FDA announced in March 2010 that it was looking into the issue of Boniva and fractures based on recent media reports. The FDA said that it had seen evidence of a clear connection, but nevertheless was looking into the issue.

femur bone fracture

This resulted in an FDA Drug Safety Communication.  The FDA does this when it wants to alert the public that it is looking at certain potential issues relating to drug complications, but is still evaluating the data. Specifically, the FDA warned that patients were at greater risk of atypical subtrochanteric femur fractures. This is a rare type of fracture that impacts the bone just below the hip joint. Although this fracture amount to less than one percent of the overall hip and femur fractures, it is more prevalent among those who are taking Boniva.  While the FDA’s conclusion was not established by scientific study, it resulted from statistics and reports of adverse incidents. As a result, the FDA stated that it could not recommend an optimal duration for Boniva treatments since long-term usage may potentially be connected with these types of fractures. The FDA required that a medication guide be given to patients when they are picking up their prescriptions.

Boniva medication

The FDA looked at several studies in reaching its conclusion. One study suggested that Boniva helped prevent fractures when used for up to five years. After that point, however, the long-term benefits dissipated. Another study looked at atypical fractures and found that 82 percent of the people who had these rare fractures were taking a bisphosphonate. The FDA did not look at whether this drug is dangerous in the first place. It only addressed complications that result from long-term usage of the drug.

what are long term effects of broken femur?

In addition to thigh bone fractures, those who have taken Boniva medication have also reported experiencing a condition known as “dead jaw.” This is similar to what happens when one does not fully recover from dental surgery. It can mean that there are loose teeth or infections in the jaw. Ultimately, this can lead the exposed jaw bone. At a certain point, the jaw bone can die and this is not fixable.  There are other side effects that have been associated with Boniva.

Boniva Product Liability Lawsuits

Lawsuits about the Bovina side effects were combined in a multi-district litigation with suits against Merck, who manufacturers a different products called Fosamax.  Plaintiffs found some success in the case when they sued the manufacturers for failure to warn about the side effects of these types of medication.  One major issue is: boniva vs fosamax?The case regarding Fosamax was initially thrown out by a lower Federal Court on a procedural issues before being revived by an appeals court. Now, the case is in front of the United States Supreme Court with an important point of law connected to failure to warn cases at issue.  The Fosamax case may change the way that drug product liability cases are litigated depending on the result at the Court.  Based on the Supreme Court’s ruling, it could lead to additional lawsuits related to the use of Bovina and other drugs of this class.

If you have taken Bovina and have suffered injury from any side effects, including atypical femoral fractures and “dead jaw,” you should immediately contact a  Boniva side effects lawyer to discuss your Boniva lawsuit legal rights. You may be entitled to financial compensation for the injury that you have suffered. As with any product liability lawsuit, your lawyer will work on a contingency basis. This means that you do not owe any money unless your Boniva lawsuit  lawyer is successful in helping you obtain a financial recovery for your injuries.

 

Sources:

https://www.reuters.com/article/us-fda-boniva/injectable-boniva-drug-in-short-supply-fda-idUSBRE85610320120607

https://saveourbones.com/whats-behind-the-sudden-decline-in-osteoporosis-ads/

https://www.nof.org/patients/what-is-osteoporosis/

https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

https://www.health.harvard.edu/blog/thigh-fractures-linked-to-osteoporosis-drugs-long-term-use-questioned-201205214737

https://www.webmd.com/osteoporosis/news/20120208/osteoporosis-medication-linked-unusual-thigh-fractures#2

https://well.blogs.nytimes.com/2012/05/09/new-cautions-about-long-term-use-of-bone-drugs/