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Fosamax and Possible Side Effects


While there is no cure for osteoporosis, appropriate treatment may help manage symptoms. There are drug products approved by the FDA to stop, slow, or prevent the progression of osteoporosis. Fosamax (Alendronate) falls under the class of bisphosphonates, a drug class that is effective at slowing or preventing bone loss in postmenopausal women. This further decreases the risk of fragility fractures, or osteoporotic bone fractures. Bone fractures that occur in patients with secondary osteoporosis often result in pain and the need for hospitalization and surgical management.

There is no known and established optimal duration for the use of bisphosphonates in osteoporosis patients. While there is no clear evidence of atypical bone fractures directly linked to bisphosphonate use, uncommon fractures have been observed in patients who are prescribed these drugs. Atypical bone fractures, such as diaphyseal femur fractures and subtrochanteric femur fractures, have been found to be associated with long-term use of bisphosphonates. Studies have indicated that these fractures account for approximately 5-10 percent of all femur and hip fractures.

FDA-approved bisphosphonate drugs for the treatment or prevention of osteoporosis must have information on the risks of atypical subtrochanteric femoral fractures and diaphyseal femoral fractures. These must be included in the warnings and precautions section. The drugs affected by the notice, issued in October 2010, include Reclast, Atelvia, Boniva, Actonel with Calcium, Fosamax Plus D, Fosamax, and the generic versions of these drug products. Conversely, other bisphosphonates used for the treatment of hypercalcemia from cancer or Paget’s disease are not affected by this FDA notice.

What are the Side Effects of Fosamax?

As with any drug product on the market, side effects may occur. Since Fosamax received FDA approval in June 1999, many severe and life-threatening side effects have been reported by patients using the drug. Possible side effects from the use of Fosamax, which may have possible grounds for a drug product liability case may include but are not limited to:

  • Musculoskeletal pain
  • Dizziness and headache
  • Osteonecrosis of the jaw (ONJ)
  • Adverse reactions in the upper gastrointestinal tract

There have been warning letters and legal proceedings on side effects from the use of Fosamax. If you experienced side effects from Fosamax use, it is advisable to seek guidance from a physician to determine if they occurred as a direct result of the drug product. From there, seek advice from an experienced drug product liability lawyer near you.

Osteonecrosis of the Jaw from Osteoporosis Drug Use

Osteonecrosis of the jaw (ONJ) is a medical condition characterized by bone exposure within the oral cavity. ONJ involves insufficient healing within eight weeks and no link to any cause. Spontaneous occurrences of ONJ have been stated on the drug label of Fosamax. Local infection accompanied by delayed healing and tooth extraction are the general associations with ONJ and Fosamax use. Known risk factors for ONJ include poor oral hygiene, concomitant therapies, cancer diagnosis, and invasive dental procedures, including dental implants and tooth extraction.

Basis for Drug Product Liability Claims

When a manufacturer releases a drug product on the market, they are responsible for ensuring the safety and efficacy of the medicine. Furthermore, manufacturers must adhere to FDA regulations for drug labeling and other criteria. This serves to ensure that patients have sufficient warning and knowledge of any potential complications or side effects that may be experienced due to drug product use. If a manufacturer fails to do so, and an individual suffers adverse effects from product use, the manufacturer may be held strictly liable for the resulting damages.

In drug product liability cases, there must be sufficient evidence demonstrating that the plaintiff used the medication as intended and was subject to dangerous or unforeseen dangers as a direct result of using the drug. If side effects from the use of Fosamax are concerning, it is best to discuss this in detail with an experienced drug product liability lawyer near you. An attorney with extensive experience, knowledge, and resources can advise a potential claimant on their options moving forward. Most lawyers, like ours at our personal injury law firm, offer free case reviews.

Importance of Working With a Lawyer on a Drug Product Liability Case

When an individual has experienced harm due to a product, it is advisable to reach out to an experienced attorney for assistance. The manufacturer, distributor, and other parties involved with the product may be held strictly liable for losses associated with an unsafe or faulty product. Eligible claimants may be compensated for medical bills, wage loss, and any other losses from the adverse effects of a drug product. A product liability lawyer can help seek maximum compensation for adverse effects experienced from the use of Fosamax and other drug products.

How an Attorney Can Help With a Drug Product Liability Claim

When an injured party retains legal counsel for a drug product liability case, their attorney will use their experience, skills, and resources to:

  • Conduct an in-depth investigation into the drug product
  • Review the FDA database, Adverse Event Reporting System (FAERS), for reports submitted for complaints on product quality, drug error, and adverse events
  • Work with expert witnesses in support of a drug product liability claim
  • Determine the value of economic and non-economic damages considering all circumstances and facts involved in the matter
  • Protect the rights of the client if the opposing party disputes the matter and alleges product misuse
  • Handle all verbal and written communications and negotiations with the other side, including insurers and defense counsel

The right attorney will go above and beyond to hold the manufacturer accountable for adverse effects associated with drug product use. To learn more about how an attorney can help, contact our law firm.

Discuss Your Case With a Drug Product Liability Lawyer

If you or a loved one has been harmed by a drug product, you may be entitled to financial compensation for your losses. Here at the Law Offices of Edward A. Smith, we have the knowledge, experience, and resources to effectively manage your Fosamax case. You deserve to have a California drug product liability lawyer who will protect your rights and have your best interests at heart. We are well-versed in California state laws and federal regulations overseeing the pharmaceutical industry. Contact us today for free, friendly advice on your potential Fosamax case at (916) 921-6400 or (800) 404-5400.

Photograph Source: Karolina Grabowska via Pexels ds llo [cs 1069]

DISCLAIMER: This document is for informational purposes only and does not constitute a Retainer/Services Agreement. No attorney-client relationship will exist between you and our firm unless and until we enter into a signed Retainer/Services Agreement. The information you obtain at this site is not, nor is it intended to be medical or legal advice. Do not stop taking any medication without consulting your physician.