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FDA Actions in Brief June 2010 (Vimovo, CIP-Tramadol ER, Zymaxid, Lumizyme, Rapamune, Sprix)
Recent FDA Approvals (through May 2010) related to Vimovo, CIP-Tramadol ER, Zymaxid, Lumizyme, Rapamune, Sprix
Naproxen and esomeprazole magnesium (Vimovo, AstraZeneca and Pozen) delayed-release tablets were approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Extended-release tramadol (CIP-Tramadol ER, Cipher) was approved for the treatment of moderate-to-moderately severe chronic pain in adults. Strengthened warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressants, and the risk of overdosage.
Gatifloxacin ophthalmic solution (Zymaxid, Allergan) 0.5% was approved for the treatment of bacterial conjunctivitis caused by susceptible strains of Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, and Streptococcus pneumoniae.
A 0.5-mg lower-dosage strength tablet of sirolimus (Rapamune, Pfizer) was approved for the prophylaxis of organ rejection in patients aged >13 years receiving kidney transplants, with specific regimens recommended for use in patients at low-to-moderate immunologic risk and in patients at high immunologic risk.
Ketorolac tromethamine nasal spray (Sprix, Roxro) was approved for the short-term (up to 5 days) management of acute moderate-to-moderately severe pain that requires analgesia at the opioid level.
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.
