Quetiapine Fumarate

WEDNESDAY, Feb. 12, 2025 -- Lithium is associated with an increased risk for thyroid dysfunction and chronic kidney disease (CKD) in patients with incident bipolar disorder (BD), according to a study published online Feb. 11 in JAMA Network Open . Joe Kwun Nam Chan, Ph.D., from the University of Hong Kong, and colleagues examined the risk for thyroid and kidney dysfunction in patients aged 15 years or older with incident BD treated with lithium and other mood stabilizers and antipsychotics in an Asian population in Hong Kong. Overall, 4,752, 4,500, and 7,029 individuals had analyzable data for hypothyroidism, hyperthyroidism , and CKD, respectively. The researchers found that compared with nonlithium treatments, lithium was associated with an increased risk for hypothyroidism and CKD3+ (adjusted hazard ratios, 2.00 and 1.35, respectively), but not with CKD4+ or end-stage kidney disease. Elevated rates of hypothyroidism, hyperthyroidism, and CKD3+ were seen in association with higher lithium serum levels (adjusted hazard ratios, 2.08, 1.81, and 2.11, respectively). There was an association seen for a greater number of lithium toxicity episodes with increased CKD3+ risk. Compared with lithium, valproate, olanzapine, quetiapine, and risperidone generally exhibited a lower likelihood of thyroid dysfunction and CKD3+, with no difference in advanced CKD. Mean lithium serum levels >0.5028, >0.5034, and >0.5865 mEq/L represented thresholds associated with hypothyroidism, hyperthyroidism, and CKD3+, respectively. "Our findings further identified thresholds of lithium serum levels associated with thyroid and kidney abnormalities, thereby providing empirical evidence to inform clinical guidelines on recommending lithium treatment that balances the efficacy and safety," the authors write. Several authors disclosed ties to the pharmaceutical and medical technology industries. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

By Bhanvi Satija and Michael Erman New York: The U.S. FDA approved Bristol Myers Squibb's schizophrenia drug on Thursday, providing patients with a treatment option that reduces symptoms of the mental disorder without common side effects. Bristol Myers obtained the drug Cobenfy , also known as KarXT , through its $14 billion takeover of Karuna Therapeutics last year. The drugmaker is banking on the treatment to help power growth as patents on its older cancer drug Revlimid and blood thinner Eliquis expire later this decade. William Blair analysts expect $2.5 billion in U.S. sales for the drug by 2030. Bristol shares rose 4 per cent in extended trading. Bristol said it expects to make the drug available to patients by late October, at a list price of $1,850 a month or about $22,500 annually. FDA's approval was based on data from two studies in which patients on the drug experienced a meaningful reduction in symptoms. The drug is the first approved antipsychotic that targets cholinergic receptors as opposed to dopamine receptors, which have long been the standard of care. "So there is an unmet need still in the treatment of schizophrenia, particularly in patients who may show response to the positive symptoms but still have residual negative symptoms," said Alan Schatzberg, psychiatry professor at Stanford University School of Medicine. Schatzberg said the drug could be a "game changer" for schizophrenia patients. While antipsychotics that target dopamine receptors reduce symptoms of the disorder, their use also causes side effects such as tremors or involuntary movements and sleepiness. Common side effects from Cobenfy in trials included vomiting, nausea, constipation among others. The FDA said Cobenfy should not be prescribed to patients with urinary retention, or those with moderate or severe kidney or liver disease. Bristol expects 80 per cent of the drug's patient population to be covered under Medicare and Medicaid insurance plans in the 12 to 18 months of its launch. "Our focus is to ensure that all of these coverage decisions are made very quickly after launch, so we can have access for patients," said Chief Commercialization Officer Adam Lenkowsky. The company expected to see significant utilization of the drug by the end of 2025, he added. Currently approved antipsychotic drugs include Vanda Pharmaceuticals' Fanapt, AbbVie's Vraylar and generic drugs like olanzapine, quetiapine and aripiprazole, among others. AbbVie is also developing newer drugs for the disease after its $8.7 billion takeover of Cerevel Therapeutics late last year. Reviva Pharmaceuticals , Neurocrine Biosciences and Celon Pharma are also developing treatments for schizophrenia. Schizophrenia causes persistent delusions and hallucinations and significantly impairs the way patients perceive reality. (Reporting by Puyaan Singh and Bhanvi Satija in Bengaluru and Michael Erman in New York; Editing by Krishna Chandra Eluri and Alan Barona)