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Merck & Co., the giant
pharmaceutical firm that formerly produced Vioxx, is the maker of Fosamax, also
known as Alendronate, used for many years to aid in reducing bone loss in
post-menopausal women. Fosamax has now been linked to numerous cases of
osteonecrosis, which is a severe bone disease of the jaw bone, and low-impact
fractures, a condition where bones become so brittle they can fracture with
very little force. The most recent case was filed in Hawaii, on behalf of a
62-year-old retired school teacher, whose simple act of stepping slightly
backwards while talking with friends led to a fracture of her femur so severe
she has required multiple surgeries to attempt to repair the bone. Fosamax is
among a group of drugs known as oral bisphosphonates, which are ironically
prescribed as treatment for women who have not yet developed osteoporosis,
while all the while contributing to a heightened susceptibility for these
debilitating conditions. Other bisphosphonates include Actonel, Boniva,
Bonefos, Didronel, Aredia, Skelid and Zometa.
As reported in the Hawaiian Star Ledger,
"As of March 31, about 1,450 Fosamax cases had been filed in the U.S.
against the pharmaceutical giant for osteonecrosis — a severe bone disease of
the jaw — [and] femur fractures and other bone injuries associated with
long-term use of the drug, according to company filings with the U.S.
Securities and Exchange Commission. Worldwide sales of Fosamax, a top-selling
drug for Merck, were $208 million in the first quarter, a 10 percent decline
from a year earlier, SEC filings show."
The U.S. FDA issued a safety warning
last year about atypical thigh-bone fractures with a possible link to the
long-term use of Fosamax, and issued a requirement that Merck add a warning
label to the product. The issue of osteonecrosis predates that warning by
several years, as far back as 2005.
From the FDA's own Safety
Communication:
[10-13-2010] The U.S. Food and Drug Administration
(FDA) is updating the
public regarding information previously communicated describing the risk of
atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur
fractures, in patients who take bisphosphonates for osteoporosis. This
information will be added to the Warnings and Precautions section of the
labels of all bisphosphonate drugs approved for the prevention or treatment of
osteoporosis.
Bisphosphonates are a class of
medicines that can be effective at preventing or slowing the loss of bone mass
(osteoporosis) in postmenopausal women, thus reducing the risk of common
osteoporotic bone fracture. Osteoporotic fractures can result in pain,
hospitalization, and surgery.
Atypical subtrochanteric femur
fractures are fractures in the bone just below the hip joint. Diaphyseal femur
fractures occur in the long part of the thigh bone. These fractures are very
uncommon and appear to account for less than 1% of all hip and femur fractures
overall. Although it is not clear if bisphosphonates are the cause, these
unusual femur fractures have been predominantly reported in patients taking
bisphosphonates.
The bisphosphonates affected by this
notice are only those approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium,
Boniva, Atelvia, and Reclast (and their generic products).
This notice does not
affect bisphosphonate drugs that only are used to treat Paget's disease or high
blood calcium levels due to cancer (i.e., Didronel, Zometa, Skelid, and their
generic products)."
Additional Information for Patients
If you currently take a
bisphosphonate, you should:
The Cartwright Law Firm currently
represents a number of individuals who have faced similar low-impact fractures
after taking Fosamax for many years. That these issues were known to both Merck
and the FDA makes the issue that much more alarming. If you or your loved ones
have been taking this prescription drug for a number of years, and have
recently suffered a bone fracture due to an act as simple as standing up, or
walking down a stairway, consider calling The Cartwright Law Firm today for
professional, experienced representation. You were assured this drug would make
your bones stronger. Now, Merck should be held accountable for failing to warn
consumers like you of a condition they had prior documented knowledge of. Let
The Cartwright Law Firm be your voice.
Serving clients throughout California,
The Cartwright Law Firm has been in existence for over 50 years in downtown San
Francisco. In that time, we have recovered tens of millions of dollars
for individuals and families struggling to pick up the pieces and start life
over again after a serious injury. For more information regarding our
practice, contact the San Francisco wrongful death and personal injury
attorneys at The Cartwright Law Firm today.
The Cartwright Law Firm
222 Front St. Fifth Floor
San Francisco, CA 94111
888-351-8460 (Toll-Free)
