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FDA advisory panel recommends stronger warning for drospirenone-containing birth control
An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.
An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.
The day-long joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of FDA in December was to involve discussion on the risks and benefits of drospirenone-containing birth control pills because of emerging safety concerns over the potentially higher risk of venous thromboembolism associated with these drugs compared with levonorgestrel-containing drugs, according to FDA meeting materials.
The committee heard testimony on research results from Bayer HealthCare Pharmaceuticals, the manufacturer of a family of drospirenone-containing birth control pills. Research results presented by Bayer demonstrated no increased risk of blood clots, which conflicted with other studies that found evidence that drospirenone was associated with higher risk of blood clot formation.
In September, FDA released a statement informing the public that it remained concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. The agency scheduled the December meeting after several studies demonstrated conflicting results.
"None of the studies to date provides a definitive answer as to the safety of [these contraceptives] with regard to thrombotic and thromboembolic events. The entire body of studies provides conflicting evidence that cannot be easily reconciled by any single difference among studies," according to the FDA materials released prior to the meeting.
Bayer HealthCare thanked the committee members for their efforts and participation in the discussion on the benefit-risk profile for drospirenone-containing combination oral contraceptives.
The company added that it will continue to work with FDA and other regulatory authorities to make label updates as appropriate.
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.
