how long has reclast been on the market

how long has reclast been on the market插图

April 16, 2007
FDA Approved: Yes (First approvedApril 16,2007) Brand name: Reclast Generic name: zoledronic acid Dosage form: Injection

What is Reclast approved for?

Reclast Approval History. Reclast (zoledronic acid) is a bisphosphonate indicated for the treatment for Paget’s disease, postmenopausal osteoporosis and prevention of fractures.

When did Reclast come out for osteoporosis?

– August 19, 2008. Reclast is the latest drug introduced to treat osteoporosis. Unlike earlier drugs of the same type – Fosamax, Actonel and Boniva – Reclast has not been approved for prevention of osteoporosis. But like the approved drugs, it is a bisphosphonate, a class of drugs that works by slowing bone breakdown.

When should Reclast be discontinued?

Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture reevaluated periodically. Reclast injection must be administered as an intravenous infusion over no less than 15 minutes.

Does Reclast have any side effects?

I have had 7 years of Reclast infusions without any noticeable side effects. My bone scans showed no worsening for 5 years, then much worse recently. I just had my first Prolia injection today. No side effects.

Why is reclast used?

Reclast may be used to treat or prevent osteoporosis caused by menopause, steroid use, or low hormone levels due to gonadal failure. Reclast may also be used to increase bone mineral density in men and to treat Paget’s disease of the bone in men and women.

How long does reclast last?

The optimal duration of use of Reclast has not been determined. Discontinuation of therapy should be considered by doctors after 3 to 5 years in patients with osteoporosis at a low risk of fracture.

What is a reclast?

Reclast is a brand (trade) name for zoledronic acid. Zoledronic acid strengthens bones and may be used for the treatment or prevention of osteoporosis. It works by inhibiting osteoclasts which are responsible for breaking down and reabsorbing bone (by a process known as bone resorption).

What medications interact with reclast?

Common medications that may interact with Reclast include: aminoglycoside antibiotics, such as amikacin, gentamicin, kanamycin, neomycin, paromomycin, or tobramycin. angiogenesis inhibitors, such as bevacizumab or everolimus. aspirin.

How long does it take to administer reclast?

Reclast must be administered over no faster than 15 minutes because shorter infusion times have been associated with an increased risk of renal toxicity which may progress to kidney failure.

Can you take Zometa with reclast?

Do not take any other medications with Reclast without first talking with your doctor. Never take other bisphosphonates (such as Zometa) while taking Reclast.

What are the side effects of a syringe?

Fever, nausea, constipation, anemia, and shortness of breath are the most frequently reported side effects. Low blood pressure, abdominal pain, and vomiting may also occur. A lowering in the levels of certain electrolytes such as phos phate, po tassium, and magnesium may occur .

How long does reclast stay in your system?

Reclast stays in your system for at least a year (hence the annual treatment). This means that you’re stuck with the drug and its side effects for as long as it’s in your system. If you experience unpleasant side effects, there’s no way to stop taking Reclast; it’s in your body for a year, doing its damage.

Can reclast infusion cause renal failure?

Renal failure as a result of Reclast infusion can quickly become fatal as doctors can’t remove the drug from your bloodstream.

Does reclast cause kidney failure?

Sadly, more than one case of Reclast infusion has resulted in deadly kidney failure, leaving hurt and confusion behind. Why didn’t the doctor warn them? Those who survive the horrible side effects of Reclast infusion are also left wondering why they weren’t warned of these possible side effects. They are also left with lasting side effects from renal toxicity.

Is reclast infusion a new treatment?

I hope this anonymous patient finds the Save Our Bones site in time, because the unfortunate truth is that Reclast infusion is a new treatment with an old story.

Does Prolia have side effects?

My bone scans showed no worsening for 5 years, then much worse recently. I just had my first Prolia injection today. No side effects. My mother had a hip fracture at age 72 and passed away from pneumonia within 10 days, due to being on hospice for early Alztimers.

Is AlgaeCal Plus good for osteoporosis?

Willis Hi I am in same case like you, I am talking. AlgaeCal Plus is very good for Osteoporosis. Thanks

What is Zolendronic acid (Reclast?)?

Zolendronic acid is used to treat or prevent osteoporosis. Osteoporosis is a disease which causes bones to become thin. You are at risk for osteoporosis if you are:

What about side effects?

The most common side effects with the injection are bone, muscle and joint pains, flu like illness and headache. The flu like symptoms generally disappear s after 24-48 hours and usually occurs only after the first injection. The most common side effects with the pill are diarrhea, pain in the extremities, and upset stomach. Less common side effects may be pain or trouble swallowing, heartburn and stomach ulcers.

What about other medications?

Tell your doctor if you are taking Zometa, a diuretic or “water pill”, or an antibiotic. Take your calcium and vitamin D as recommended by your doctor.

How long does zolendronic acid last?

Zolendronic acid is given as an infusion (through a vein in your arm) lasting 15 minutes. You should drink 2 glasses of fluid at least one hour before receiving your infusion. You may eat normally before your infusion. Zolendronic acid infusions are once a year.

How long does it take for bisphosphonate to cause pain?

Rarely patients have reported severe bone, joint and muscle pain that begins from 1 day to one month after starting any bisphosphonate, including Zolendronic acid.

Is Johns Hopkins Arthritis Center educational?

All information contained within the Johns Hopkins Arthritis Center website is intended for educational purposes only. Physicians and other health care professionals are encouraged to consult other sources and confirm the information contained within this site. Consumers should never disregard medical advice or delay in seeking it because of something they may have read on this website.

Can you get bone density test for osteoporosis?

Your doctor may order bone density tests to follow your osteoporosis. Contact your doctor if you have any questions about this or any of your medications. Contact your doctor if you experience any troubling side effects.

How is Reclast given?

Reclast is given as an infusion into a vein. A healthcare provider will give you this injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What is the name of the medicine that treats high calcium levels?

Zometa is another brand of zoledronic acid used to treat high blood levels of calcium caused by cancer (also called hypercalcemia of malignancy). This medicine also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body. You should not use Reclast and Zometa at the same time.

What is the best medicine for osteoporosis?

Reclast is used to treat or prevent osteoporosis caused by menopause, or steroid use. This medicine also increases bone mass in men with osteoporosis. Reclast is for use when you have a high risk of bone fracture. Reclast is also used to treat Paget’s disease of bone. Zometa is another brand of zoledronic acid used to treat high blood levels …

What is zoledronic acid?

Reclast ( zoledronic acid) (sometimes called zoledronate) is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures. Reclast is used to treat or prevent osteoporosis caused by menopause, or steroid use.

How long does reclast last?

Follow your doctor’s instructions very closely. Your doctor will determine how long to treat you with this medicine. Reclast is often given for only 3 to 5 years.

How long does zoledronic acid stay in your system?

Zoledronic acid can remain in your body for weeks or years after your last dose. Use effective birth control to prevent pregnancy while using this medicine. Talk with your doctor about the need to prevent pregnancy after you stop using Reclast. This medicine may affect fertility (ability to have children) in women.

Why is reclast not recommended?

Maizes tells me that she is hesitant to recommend Reclast for two reasons. The first is that studies of the drug have shown that it can increase risk of atrial fibrillation, a disorder in which the two upper chambers of the heart quiver instead of beating in an organized and efficient fashion. Atrial fibrillation usually is not life-threatening but can be dangerous. It requires treatment, because over time it can lead to stroke and heart failure.

How does reclast work?

But like the approved drugs, it is a bisphosphonate, a class of drugs that works by slowing bone breakdown. Reclast has an obvious appeal – it is given as a once-a-year injection, freeing patients from the need to take drugs weekly or monthly.

Why do women take bisphosphonates?

Most of those affected have been cancer patients who needed the drug to help control bone loss after their disease had spread to the bones, but some are women who took bisphosphonates for osteoporosis prevention or treatment .

Is reclast a good drug?

Is it a good idea? Reclast is the latest drug introduced to treat osteoporosis. Unlike earlier drugs of the same type – Fosamax, Actonel and Boniva – Reclast has not been approved for prevention of osteoporosis. But like the approved drugs, it is a bisphosphonate, a class of drugs that works by slowing bone breakdown.

Can osteoporosis patients take their medication?

The advantage is billed as convenience for patients, but the real issue is historically poor compliance with osteoporosis medications: patients often don’t fill prescription s, don’t take their medication regularly, or just stop taking it.

How long does it take for reclast to increase BMD?

Reclast significantly increased BMD at the lumbar spine, total hip and femoral neck, relative to treatment with placebo at time points 12, 24, and 36 months. Treatment with Reclast resulted in a 6.7% increase in BMD at the lumbar spine, 6.0% at the total hip, and 5.1% at the femoral neck, over 3 years as compared to placebo.

What is reclast treatment?

Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [ see Clinical Studies (14.5) ].

How much does reclast reduce hip fracture risk?

Reclast demonstrated a 1.1% absolute reduction and 41% relative reduction in the risk of hip fractures over a median duration of follow-up of 3 years. The hip fracture event rate was 1.4% for Reclast-treated patients compared to 2.5% for placebo-treated patients.

What is reclast used for?

Reclast is indicated for treatment of osteoporosis in post menopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Reclast reduces the incidence of fractures (hip, vertebral, and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined …

What is the recommended daily dose of reclast?

Reclast is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months [ see Clinical Studies (14.4) ].

What are the symptoms of reclast?

In patients given Reclast at randomization and placebo at Month 12, Reclast was associated with signs and symptoms of an acute phase reaction: myalgia (20.4%), fever (19.3%), chills (18.2%), pain (13.8%) , headache (13.3%), fatigue (8.3%), arthralgia (6.1%), pain in extremity (3.9%), influenza-like illness (3.3%), and back pain (1.7%), which occurred within the first 3 days following the dose of Reclast. The majority of these symptoms were mild to moderate and resolved within 3 days of the event onset but resolution could take up to 7-14 days.

How old are the patients in the osteoporosis trial?

The combined osteoporosis trials included 4863 Reclast-treated patients who were at least 65 years of age, while 2101 patients were at least 75 years old. No overall differences in efficacy or safety were observed between patients under 75 years of age with those at least 75 years of age, except that the acute phase reactions occurred less frequently in the older patients.

How often is reclast given?

Reclast is given once a year for treatment of osteoporosis in men and postmeopausal women and once every two years for prevention of osteoporosis in postmenopausal women. Wolfe noted that more than one million infusions of Aclasta had been administered worldwide as of October 2010. The 265 cases of renal impairment reported in Canada corresponds …

What are the side effects of reclast?

As I wrote in my Reclast review, the most commonly reported Reclast side effects are fever, muscle, joint and bone pain, flu-like symptoms, and fever.

What did the public citizen want?

The consumer group Public Citizen wants the U.S. Food and Drug Administration to do what Canada apparently did five months ago – tell Novartis to warn physicians and consumers about a dangerous link between a widely-used osteoporosis drug and serious renal toxicity, which can result in death.

Does reclast grow new bone?

Also, Reclast does not grow new bone, it is suppose to repair bone, but from all of my research, it does more harm than it could ever do good. I will probably have to change doctors, but “it is what it is”. I have been taking the Bovine Powder for about six months now, and I am no longer having hip pain.

Is Reclast the same as Canadian?

The drug is called Reclast in the U.S. and is identical to the Canadian version. Five months later, the FDA has done nothing, said Public Citizen’s Sidney Wolfe, M.D., in a letter to FDA Commissioner Margaret Hamburg, M.D.

Is reclasta the same as zoledronic acid?

In a letter to the FDA, Public Citizen’s Health Research Group said the Canadian government reacted after learning of 265 cases of serious kidney impairment in patients using Aclasta (zoledronic acid). The drug is called Reclast in the U.S. and is identical to the Canadian version. Five months later, the FDA has done nothing, …

In Summary

Common side effects of Reclast include: hypophosphatemia, hypokalemia, and hypomagnesemia. Other side effects include: hypocalcemia. See below for a comprehensive list of adverse effects.

For the Consumer

Along with its needed effects, zoledronic acid (the active ingredient contained in Reclast) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

For Healthcare Professionals

Applies to zoledronic acid: intravenous powder for injection, intravenous solution

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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