Janssen Pharmaceuticals has stopped making Levaquin (levofloxacin), a fluoroquinolone antibiotic associated with many side effects. In December, Janssen, which is part of pharma giant Johnson & Johnson, discontinued both the oral and IV versions. They company claimed the reason for the discontinuation was due to the availability of other treatment options as well as their aim to develop medicines for unmet needs. Levaquin may still be available in pharmacies through 2020, however. Despite Janssen’s move, generic versions of levofloxacin will still be made. Brand-name Levaquin was only 1% of the market share. In 2016, the FDA issued a “boxed warning” on fluoroquinolone antibiotics, the most severe the agency can order for a drug. This highlighted the risk of serious side effects including disturbances in attention, disorientation, agitation, nervousness, memory impairment, serious disturbances in mental abilities, and delirium. Last month, the agency also mandated another labeling change for fluoroquinolones. Posted July 17, 2018. Via The Indy Channel.
While cannabinoids, active ingredients in marijuana, are useful in controlling seizures, they also have the potential for causing adverse events. An analysis, conducted by the UK’s National Institute for Health Research, of 6 randomized controlled trials and 30 observational trials examined the use of cannabidiol, a medical-quality cannabinoid, to placebo in patients, most of whom had severe epilepsy. Patients on cannabidiol saw seizure-free chances increase by 7.8% compared to only 0.7% of those on placebo. Reducing seizure frequency by at least 50% was observed at 43.5% in the cannabidiol group compared to 25% in the placebo group. However, adverse events did increase in those taking cannabidiol compared to placebo (88.4% to 69.7%). In late June, the FDA approved the first cannabidiol-based drug, Epidiolex, for severe seizures. Posted July 30, 2018. Via Nursing Times.
The FDA is warning of dangers and false claims associated with so-called “vaginal rejuvenation” devices. The procedure uses lasers and other energy-based devices to destroy and/ or reshape vaginal tissue and is intended to treat menopausal symptoms as well as urinary inconsistencies or sexual function. The FDA has approved these devices to remove precancerous vaginal or cervical tissue along with genital warts, but has not approved its use for “vaginal rejuvenation.” Serious risks based on reports have been found with the procedure and there is no evidence to see if it is effective. After reviewing reports on the procedure, the FDA found that it can leave vaginal burns, scarring, pain during sex, and recurring/chronic pain. Since it has not been thoroughly reviewed, not all of the risks are known. The FDA has given companies offering the procedure 30 days to respond to questions they have. Posted July 30, 2018 Via FDA.