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FDA approves first Boniva generics to treat or prevent osteoporosis
FDA approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause
FDA approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.
Apotex, Orchid Healthcare, and Mylan Pharmaceuticals have gained FDA approval to make generic 150-mg ibandronate tablets.
The most common type of bone disease, osteoporosis, is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures of the hip, spine, and wrist. Ibandronate is in a class of medications called bisphosphonates that help increase bone mass and reduce the chance of having a spinal fracture.
According to the National Institutes of Health, in the United States more than 40 million people either already have osteoporosis or are at high risk due to low bone mass.
“Men as well as women are affected by osteoporosis, a disease that can be prevented and treated,” Keith Webber, PhD, deputy director of the Office of Pharmaceutical Science in FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “For people who must manage their health conditions over time, it is important to have affordable treatment options.”
An FDA-required Medication Guide will be given to patients and caregivers when ibandronate is dispensed, describes the risks and adverse reactions people should be mindful of when using the drug. Ibandronate can cause serious side effects including: esophagus problems; low calcium levels in the blood; bone, joint, or muscle pain; severe jaw-bone problems; and unusual thigh-bone fractures.
In the clinical trials for Boniva, the most commonly observed adverse reactions were back pain, indigestion (dyspepsia), pain in extremity, diarrhea, headache, and muscle pain (myalgia).
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
