INFO, HEALTH TIPS AND NEWS

The use of contraceptives has been largely associated with women, but birth control for men might soon be available for use after Indian scientists announced that they have successfully completed clinical trials on the world’s first male birth control injection. The Indian Council for Medical Research said that the “product is ready,” and has a 97.3% success rate with no side effects, according to a report from the Hindustan Times. The contraceptive works via an injection to the vas deferens, the sperm-containing tube near the testicles. It contains a polymer called Steryene Maleic Anhydride, which was developed in the 1970s to inhibit sperm production. According to the report, the contraceptive will be effective for 13 years. VG Somani, the Drug Controller General of India, estimates approval of the drug to take around six months, minimum. “It’s the first in the world from India so we have to be extra careful about approval. We are looking at all aspects, especiall...

By John Miller and Carl O’Donnell (Reuters) - Novartis AG on Friday won U.S. approval for its experimental sickle cell disease drug, Adakveo, making it the first of several proposed new therapies designed to offer lasting relief for patients with the debilitating blood disease to get U.S. regulatory clearance. The drug will be priced between $84,852 and $113,136 per year for most patients, who will be infused by a healthcare provider with between three and four vials each month, Novartis said. The biologic drug, also known as crizanlizumab, was shown in trials in its high-dose formula to cut sickle cell pain crises nearly by half to 1.63 incidents annually from 2.98 in those getting a placebo. The Food and Drug Administration’s approval came nearly two months ahead of its due date for a decision in January. Novartis has forecast that the drug’s annual sales will top $1 billion, much of which will likely come from U.S. government payers such as Medicare and Medicaid. The dru...

A sampling of  levothyroxine  (LT4) liquid formulations obtained from compounding pharmacies and student pharmacists using state-of-the-art equipment, shows substantial variation in the active drug components of such products, potentially posing health risks, new research shows. "The results [of our study] were dramatic and it was a surprise to see this level of variation," Charles A. Carter, PharmD, said when presenting the findings here at the  American Thyroid Association (ATA) 89th Annual Meeting. "The compounded liquid formulation products are unlikely to provide precision in the prescribed dose, and reliable product performance is not likely to occur when administered to patients," said Carter, of the Department of Clinical Research, Campbell University, Buies Creek, North Carolina. Whether it's poorly mixed formula or concentrations significantly different from those expected in the prescription, the consequences could affect patient health, Jacq...

A recent statement from an EU panel restricting use of "high-strength"  estradiol vaginal  creams to just 4 weeks has caused some confusion, but also illustrates actual differences between the European and US approaches to regulating the products. The October 4  statement  said that the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) "recommended limiting the use of high-strength creams containing 100 micrograms/gram (0.01%) of  estradiol  to a single treatment period of up to 4 weeks," as  reported  by  Medscape Medical News . The advice, which reconfirms a  2014 recommendation , "is intended to minimize the risk of side effects such as blood clots, strokes, and certain types of cancer caused by  estradiol  absorbed into the bloodstream from creams applied inside the vagina to treat symptoms of vaginal atrophy in women who have been through  menopause ."   In response a w...

The US Food and Drug Administration (FDA) has approved the antibacterial drug cefiderocol ( Fetroja , Shionogi & Co) for complicated urinary tract infections (cUTI), including kidney infections, caused by susceptible Gram-negative microorganisms in patients age 18 years or older with few or no alternative treatment options. Cefiderocol is a cephalosporin antibiotic with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore, the company noted in a  news release  announcing approval. The approval follows a 14 to 2 vote last month in favor of approval by the FDA's Antimicrobial Drugs Advisory Committee,  as reported by   Medscape Medical News .  "I think the data from the cUTI study were straightforward and demonstrated meaningful activity," committee chairperson Lindsey R. Baden, MD, director of clinical research, Division of Infectious Diseases, Brigham and Women's Hospital, and as...