- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
FDA updates drospirenone-containing birth control pill labels to emphasize possible increased risk of blood clots in women
Drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills, according to recent FDA observational (epidemiologic) studies.
Drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills, according to recent FDA observational (epidemiologic) studies.
Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. Based on its review, FDA is adding information about the risk of blood clots to the labels of drospirenone-containing birth control pills, including drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets (Beyaz, Bayer), drospirenone/ethinyl estradiol/levomefolate calcium tablets (Safyral, Bayer), levomefolate calcium tablets and drospirenone/ethinyl estradiol (Yasmin, Bayer), and drospirenone/ethinyl estradiol (Yaz, Bayer).
CONTROVERSY ALREADY EXISTED
"While it is well-justified for FDA to now issue product labeling changes based upon review of this more recent epidemiologic data, it should also be noted that general risk of clotting still remains relatively low with all oral contraceptives, and epidemiologic evidence can be muddled by a wide array of confounding factors," Calabrese continued. "Nonetheless, providers should take heed in closely monitoring and evaluating these data and labeling changes for themselves and openly discussing the risks and benefits of various oral contraceptive options with their patients."
According to a Bayer press release, the updated United States labels state that combined oral contraceptives containing drospirenone may be associated with a higher risk of venous thromboembolism (VTE) than combined oral contraceptives containing levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a 3-fold increase. The labels state that before initiating use of drospirenone-containing combined oral contraceptives in a new combined oral contraceptive user or a woman who is switching from a contraceptive that does not contain drospirenone, consider the risks and benefits of a drospirenone-containing combined oral contraceptive in light of her risk of a VTE.
TALK ABOUT RISKS
Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of combined oral contraceptives. The risk of VTE is highest during the first year of combined oral contraceptive use. The greatest risk of VTE is present after initially starting a combined oral contraceptive or restarting (following a 4-week or greater pill-free interval) the same or a different combined oral contraceptive.
The revised labels update information that there is a risk of VTE among all combined oral contraceptives, but that the risk of VTE associated with pregnancy is even greater than the risk associated with any combined oral contraceptive use, including drospirenone-containing combined oral contraceptives.
In 2011, Bayer HealthCare Pharmaceuticals updated labels for drospirenone-containing products in various countries, (eg, Europe, Canada, and Australia).
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.
