Reclast Class Action Lawsuit

Pharmaceutical companies always seem to have a new drug that cures one problem, but also creates more problems than they solve. If you are one of the many people who were treated with a Novartis medication called Reclast then you’ll find the following information very important.

What is Reclast?

Reclast- Zoledronic acid is a dug that is used to treat the condition known as Paget’s disease as well as for the treatment of osteoporosis in postmenopausal women, and in some cases is also prescribed for men to treat their cases of osteoporosis also.

How is Reclast Used?

Reclast is a prescription medication that is given to patients once a year in a 15 minute intravenous infusion. In patients with cancer, it is sometimes administered to treat instances of hypercalcemia, a condition which cause high levels of calcium in a patient’s blood.

The Novartis drug is also prescribed to treat bone damage caused by Paget’s disease, other forms of cancer that attack the bones and multiple myeloma.

Reclast has been shown in studies to decrease the frequency of fractures of the hip, along with vertebral and non-vertebral osteoporosis-related fractures.

Side Effects

There are several side effects associated with this medication including:

  • Fever
  • Muscle, joint, and bone pain
  • Flu-like symptoms
  • Headaches
  • Atrial Fibrillation
  • Severe Musculoskeletal Pain
  • Kidney Failure
  • Fractures of the Femur

There is one side effect caused by Reclast that is quite devastating. It’s a condition called dead jaw. The medical term for dead jaw is called osteonecrosis of the jaw, and it’s a condition that retards the recovery of the jaw after any dental procedure.

Patients who suffer from this condition loss jaw tissue due to infection, and eventually the infected tissue just dies. What happens afterward is that the person who has this disease can expect to become disfigured, as well as bone exposure.

The FDA and Reclast

The FDA has had some involvement in regulating Reclast, but its methods have come under fire. In a letter sent to the FDA from a group called the Public Citizen’s Health Research Group, the letter mentions the Canadian government’s reaction to information detailing at least 265 cases problems with patient’s kidneys after taking a medication called Aclasta, and in the U.S. it’s called Reclast.

Five months after they received that letter, the FDA not acted on the information contained within that letter.

Another letter sent to the FDA from Sidney Wolfe, M.D., the organization was again under fire because it had not taken any actions against Novartis for not alerting the public and health care professionals about the dangers associated with this drug.

FDA Recalls

The FDA did issue some warnings against Reclast. The first warning was reported on the Jere Beasley Report on October 6, 2011. The FDA basically just gave a slap on the wrist to Novartis, the manufacturer of Reclast after they received information about five deaths from acute kidney failure in 2009. They also received reports of eleven deaths as well as at least nine cases of kidney failure in patients taking this medication.

In September of 2011, the FDA finally warned the general public and healthcare professionals about the dangers of using Reclast, mentioning that the drug could cause kidney failure in patients who have taken the drug.

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