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Ozempic Side Effects ‘Well-Known,’ Novo Nordisk Argues
Novo Nordisk has refuted a Louisiana woman’s claim that her doctors weren’t properly warned of the side effects of the company’s blockbuster drug Ozempic, saying the vomiting and pain she alleged to have experienced are documented side effects included on the drug’s label.
The Danish drugmaker filed a motion to dismiss Jaclyn Bjorklund’s lawsuit against the company on Friday in Louisiana federal court. Bjorklund said that while taking the drug for Type 2 Diabetes she developed gastroparesis, a slowdown in the emptying of the stomach into the small intestine, that led to her vomiting and pain.
The company in its motion to dismiss said the delay is actually part of how the drug works to improve blood sugar management. It also said that her symptoms were “extensively discussed” on the U.S. Food and Drug Administration’s approved label for the drug. Novo further argued that the Louisiana law Bjorklund cites in her lawsuit doesn’t require physicians to be warned “about known risks such as the well-known side effects of Ozempic and Mounjaro she claims to have experienced.”
Court records show Bjorklund was one of the first people to sue Novo Nordisk about the side effects associated with Ozempic, which is among several drugs originally developed to help treat diabetes that have boomed in popularity because of their effectiveness in helping with weight loss. At least two similar lawsuits are pending, one in Louisiana federal court and one in Pennsylvania federal court, records show.
Ozempic Class Action Lawsuit Over Gastroparesis Risk Filed in Canada
Novo Nordisk faces a class action lawsuit over Ozempic in Canada, presenting claims similar to a growing number of complaints now being filed in the U.S., indicating that the maker of the popular diabetes and weight loss drug failed to adequately warn about the risk of gastroparesis, also known as stomach paralysis.
The complaint was filed last month by Suzanne Talbot in the Supreme Court of British Columbia, indicating that side effects of Ozempic caused a blockage in her biliary system, resulting in severe pain, chronic diarrhea, heartburn and hospitalization.
Ozempic (semaglutide) was initially introduced for the treatment of people with Type 2 diabetes. However, amid aggressive advertisements that promoted the weight loss benefits, Ozempic has been increasingly prescribed as a diet drug in recent years, leading the drug maker to introduce a higher dose version, known as Wegovy, which is specifically approved for weight loss use.
Although the drug has been marketed as safe and effective, concerns have emerged in recent months about painful and debilitating gastrointestinal problems from Ozempic and Wegovy, primarily involving a medical condition known as gastroparesis, which results from delayed emptying of the stomach.
As a result of the drug maker’s failure to sufficiently disclose the risk, a number of former users are now pursuing Ozempic lawsuits and Wegovy lawsuits in both the U.S. and Canada, each raising similar allegations that they developed painful and debilitating stomach problems, which could have been avoided if false and misleading information had not been provided for users and the medical community.
Uptake of Flu Vaccine Among Healthcare Workers Falls to Just Over Half of All Staff
Uptake of the flu vaccine among hospital healthcare workers fell by almost 10% last winter, with rates varying significantly across the country. Just over half of hospital staff (54.2%) were vaccinated against influenza in the 2022/23 winter season, down from 64% the previous year, according to a new report.
The report, prepared by the Health Protection Surveillance Centre (HPSC) and published on its website last month, surveyed staff in 49 hospitals, just three of which are privately run.
The report’s authors said that uptake recorded among healthcare workers was a ‘marked reduction’ compared to the previous winter. However, it added that under-reporting of vaccinations could have occurred because of staff receiving the inoculation in settings outside of their workplace, and issues with the Health Service Executive (HSE’s) national COVAX vaccine reporting system which maintains data on vaccination rates.
A statement from the HSE said that the organization has implemented ‘a comprehensive plan’ to increase flu vaccination rates among workers, which includes the opportunity for staff to avail of both the flu and COVID-19 vaccines at staff vaccination clinics across the country. “In addition, health and care workers may also avail of vaccines with participating GPs and pharmacies,” the statement added.
Biogen-Sage Therapeutics Postpartum Depression Pill Priced at $15,900
Biogen (BIIB.O) and Sage Therapeutics’ (SAGE.O) oral pill to treat postpartum depression (PPD) in adults is expected to cost U.S. wholesalers $15,900 for a full 14-day treatment, Sage Therapeutics said on Tuesday.
The drug, Zurzuvae, is expected to be commercially available for adults with PPD in December.
The companies had sought U.S. approval for Zurzuvae to treat major depressive disorder (MDD), or clinical depression, and postpartum depression, but the Food and Drug Administration in August approved it only for PPD.
Jefferies had estimated peak sales of more than $1 billion for the drug if it was approved to treat clinical depression, and $250 million to $500 million for postpartum depression.
U.S. Orders Puerto Rico Drug Distribution Company to Pay $12 Million in Opioid Case
One of Puerto Rico’s biggest distributors of pharmaceutical drugs was ordered to pay $12 million after being accused of not reporting hundreds of suspicious orders for controlled substances, the U.S. Justice Department said Monday.
Drogueria Betances, LLC is accused of not reporting at least 655 orders for fentanyl and at least 113 orders for oxycodone from 2016 through June 2019. The orders were considered suspicious given in part their frequency and size, the department said.
The company also is accused of hundreds of record-keeping violations and of not submitting reports of its distribution transactions to the U.S. Drug Enforcement Administration, including those involving opioids, from May 2017 to July 2018, officials said.
Judge Trims U.S. Lawsuit Accusing Cencora of Fueling Opioid Epidemic
A federal judge on Monday pared back a U.S. government lawsuit accusing drug distributor Cencora (COR.N), formerly called AmerisourceBergen, of fueling the nation’s deadly opioid epidemic by failing to report hundreds of thousands of suspicious orders of prescription painkillers.
U.S. District Judge Jerry Pappert in Philadelphia federal court ruled that the government could only seek penalties for alleged failure to report suspicious orders after October 2018, when the federal Controlled Substances Act was amended to explicitly require such reports. The government’s lawsuit, filed last December, claimed that the company failed to report suspicious orders going back to 2014.
It was not immediately clear how large an effect the order could have on Cencora’s potential liability in the case. The U.S. Department of Justice declined to comment, and Cencora did not immediately respond to a request for comment.
The government claimed in its lawsuit that Cencora systematically refused or negligently failed to flag suspicious orders by pharmacy customers when it had reason to know that opioids were being diverted to illegal channels.
Kenya Manufacturer Is First in Africa to Get WHO Approval for Malaria Drug
A Kenyan pharmaceutical company, Universal Corporation Limited, has become the first manufacturer in Africa to receive World Health Organization (WHO) approval to produce a lifesaving malaria drug.
The antimalarial drug, sulfadoxine-pyrimethamine plus amodiaquine (Spaq), is frequently used to prevent seasonal malaria in children during months of peak transmission periods such as rainy seasons. Previously, demand for drugs such as Spaq in Africa has been met through the importation of generic versions of the medicine from India and China.
Big Pharma Wants to Use AI to Increase Diversity in Clinical Trials
Black Americans are twice as likely as their White counterparts to develop multiple myeloma, but their participation rate in clinical trials of treatments for bone marrow cancer is a dismal 4.8%. Now drug giant Johnson & Johnson says it’s had success increasing that share by using an untraditional tool: artificial intelligence.
Algorithms helped J&J pinpoint community centers where Black patients with this cancer might seek treatment. That information helped lift the Black enrollment rate in five ongoing studies to about 10%, the company says. Prominent academic centers or clinics that have traditionally done trials are often not easily accessible by minority or low-income patients because of distance or cost.
