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Fosamax and Ortho Evra - Risks and Side Effects
Fosamax and Jaw death ( ONJ )
Fosamax is a medicine in the bisphosphonates family that is commonly prescribed to prevent bone loss or the decrease of bone density. There have been reports that persons taking Fosamax have developed a severe problem in which bone in their jaws dies. Thisjaw death, or Osteonecrosis of the jaw (ONJ), often appears after minor trauma such as a tooth extraction. Many patients who take Fosamax, or other bisphosphonates such as Actonel, may be at risk of developing this terrible complication.
What is ONJ?
Osteonecrosis of the Jaw ( ONJ ) also sometimes referred to as jaw death, bisphosphonate-associated osteonecrosis (BON) or osteochemonecrosis is a condition in which the bones that form the jaw begin to die. In most cases, the soft tissue that surrounds the teeth and covers the bones of the jaw recedes, and jaw bone becomes exposed. The jaw bone is then very susceptible to infection, especially after any trauma such as having teeth pulled, and the bone begins to die away. In serious cases, pieces of dead (necrotized) bone must often be removed, teeth may become loose or fall out, and sores can develop in the gums near the exposed bone. In the most severe cases, the jaw bone substantially disintegrates, leading to increased risk of jaw fractures and significant loss of bone.
What are the symptoms of ONJ?
The most distinctive symptom of ONJ is exposed bone in the mouth. Early signs of ONJ also include pain or swelling in the jaw, gum infections and sores that do not heal normally, a sensation of heaviness or numbness or other unusual feelings in the jaw, drainage or discharge from the jaw, and loosening of teeth. Because the early symptoms of ONJ resemble the symptoms of other dental problems, it is important to consult with a dentist in order to obtain an accurate diagnosis.
Texas FOSAMAX Attorneys will help you in your hour of need.CONTACT USToday.
FDA Announcement and Ortho Evra
Ortho Evra skin patch was the first skin patch approved for birth control. On November 10, 2005, the FDA announced a change to the labeling of the Ortho Evra contraceptive patch. The patch is manufactured by Johnson and Johnsons Ortho McNeil. The Ortho Evra patch is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone). The Ortho Evra contraceptive patch contains higher levels of a hormone known to cause blood clots than the average birth control pills. Women who use Ortho Evra are subject to 60% more estrogen than those using the birth control pill.
According to FDA reports, a dozen women died last year from blood clots believed to be related to the Ortho Evra patch. The reports also linked the birth control patch to dozens of other non-fatal strokes and blood clots. The FDA said it has received 21 reports of life-threatening blood clots and other ailments associated with Ortho Evra use.
Approximately 4 million women have used the Ortho Evra patch since it went on sale in 2002. FDA records show that seventeen (17) users of the Ortho Evra patch between the ages of 17 and 30 have suffered fatal heart attacks, blood clots, and possible strokes since August, 2002. Ortho-McNeil, the manufacturer of the birth control patch, has aggressively marketed the patch as a convenient alternative to oral birth control pills.
If you or a loved one has experienced a heart attack, stroke, or serious clot while using the Ortho Evra patch, you may want to consider your potential legal claim for this loss. If you would like the experienced attorneys at Baily & Galyen to evaluate your claim, Contact us at 1-800-529-8008.Our experienced staff will assist you with your claim.
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Bailey & Galyen are experienced, Texas product liability lawyers, and they will fight for your right to receive just compensation for the pain and suffering you have endured as the result of a dangerous and defective product. We are Board Certified Personal Injury Attorneys. Whether your injury is the result of a pharmaceutical product such as Vioxx, Seroquel, Fosamax, Ortho Evra or other dangerous product, we can help. Whatever product has caused your injury, your deserve to have your injuries compensated. Call 866-715-1529 or Contact us today for a free, initial consultation to discuss the merits of your Texas product liability lawsuit.
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Drugs and Medical Devices - An Overview
The costs of defective drugs and medical devices are great. Having defective drugs and medical devices on the market can lead to significant health risks in consumers. Risks can cause serious injury, disabilities and hospitalization. In some cases, injuries lead to more intensive surgeries than where originally necessary to correct the damage caused by the defect. Some harms caused by defective prescription drugs and medical devices also cause death. Fatal injuries caused by defects have been on the rise the past decade. This increase has lead to drugs being pulled off the markets, class action lawsuits, safety concerns and liability issues; we want to know who to blame.
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Defective Drugs
When a consumer receives a prescription for medication from his or her physician he or she would likely believe that drug is safe. However, safe does not necessarily mean harmless. According to the US Food and Drug Administration, “safe” means that the benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use. A defective drug is one whose potential risks offset its anticipated benefits. Likewise, a defective drug is one whose potential risks outweigh its possible benefits to the consumer.
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Defective Medical Devices
Medical devices are used to ease pain, help with disabilities and save lives. However, when these devices are flawed they may cause serious injury and death. Some medical device defects may include faulty design or insufficient manufacturing quality and are considered instruments used for treatment, diagnosis or prevention of disease or injury. The FDA categories of devices are complex and widely varied and many of the adverse effects of medical devices are preventable.
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Legal Duty of Manufacturer
We all rely on medications and medical products to help gain a higher quality of life or better health. However, not all drugs or medical products are helpful. Some may have been defectively manufactured or may be unsafe. These medical products may pose dangerous risks or injury. Drug and medical device manufacturers have a legal duty to make a safe product, test their products, meet FDA standards and approvals for their products (prior to entering the market) and to issue the appropriate warnings for any risks associated with their products. Likewise, physicians and pharmacists have a duty to rely manufacturers’ warnings to their patients or consumers when it is necessary and appropriate to avoid consumer injuries. If you have been injured by a drug or a medical device, you may be entitled to compensation for your injury.
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What Can You Do?
Manufacturers, physicians and pharmacists may be held liable for certain drug and medical device defects, but ultimately you are responsible for your own health. Keep yourself aware and knowledgeable of your medical treatment. You are accountable for taking your prescription correctly, taking the right dosage and not abusing your medications.
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Frequently Asked Questions about Drugs and Medical Devices
Q: Who is liable for harm suffered from prescription drugs?
A: Depending on the facts of your case, liable parties can range from drug and medical device manufacturers, to your treating physician, to the pharmacy that dispensed the medication.
Q: How can I find out if a medication I have been prescribed is dangerous?
A: Always ask your physician questions you have about medications he or she prescribes you. Also ask your pharmacist about possible risks and instructions on how to take your medications. If you are already taking a medication and would like to make sure it is still safe, check with the FDA Web site or the MedWatch Web site for updates on dangerous drugs.
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Drugs and Medical Devices Resource Links
United States Food and Drug Administration (FDA)
The FDA is the main federal agency charged with drug and medical device safety. The FDA's Web site includes news, product reports and approvals, safety alerts and recalls.
MedWatch
This Web site contains the FDA safety information and adverse event reporting program used by consumers to report defective drugs or medical devices or to check the status of medical products.
Breast Implants on Trial
From PBS's Frontline, this Web site includes news, documents, studies and other information related to breast implant defects and litigation.
Institute for Safe Medication Practices
The Institute for Safe Medication Practices is a nonprofit organization devoted to medication safety and serving health care providers and consumers.
RegSource.com
this Web site offers regulatory information and news on drugs, biologics, medical devices and pharmaceuticals.
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Bailey & Galyen are experienced, Texas product liability lawyers, and they will fight for your right to just compensation under the law for the pain and suffering you have endured due to a defective product. Contact us today to speak with your Texas product liability attorney about proceeding with product liability litigation.
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