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Nationwide Antidepressant Recall Update as FDA Sets Risk Class
Thousands of bottles of antidepressants have been recalled across the U.S. after they were found to contain levels of a potentially cancer-causing chemical above the acceptable limit as set out by the U.S. Food and Drug Administration (FDA).
The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on Oct. 10 and has been given the second highest risk classification by the FDA.
Duloxetine is a medication used to manage depression, anxiety, and nerve pain, such as fibromyalgia. It works by increasing levels of mood-boosting chemicals in the brain. However, during its production, low levels of a chemical called N-nitroso-duloxetine can also be produced.
This chemical belongs to a group of chemicals called nitrosamines that are commonly found in water and food products.
However, when they are present in higher concentrations, and we are exposed to them for an extended period of time, these chemicals may increase our risk of developing cancer. As a result, their concentrations are strictly limited by the FDA.
Drug Companies That Violate Law Would Fund Medical Research Under New Democratic Legislation
Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.) have introduced legislation that would require pharmaceutical companies who have entered settlement agreements over violating federal law to invest a portion of their profits into key agencies.
Titled the “Medical Innovation Act,” the bill would apply to large drugmakers who are found to have violated federal laws and also have received federal funding that helped them develop what the bill calls “blockbuster drugs.” The legislation defines these drugs as those that had net sales of at least $1 billion in the previous calendar year.
Funds collected through this legislation would go towards initiatives in the National Institutes of Health and the Food and Drug Administration. Companies would be required to invest a percentage of their profits into these federal health agencies for five years.
Warren’s office identified at least 40 pharmaceutical companies in the last five years that would be affected by this bill. “Big Pharma shouldn’t be able to defraud the federal government and get away with just a slap on the wrist,” Warren said in a statement. “This bill will help us save lives by ensuring giant drug companies that enter into settlement agreements with the federal government chip in to fund the next generation of medical research.”
Montelukast Didn’t Cut Time to COVID Symptom Relief in Clinical Trial
A 14-day course of the oral anti-inflammatory drug montelukast didn’t shorten symptom duration in nonhospitalized U.S. adults with mild or moderate COVID-19, finds a randomized controlled clinical trial published today in JAMA Network Open.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines-6 (ACTIV-6) Study Group and Investigators randomly assigned 1,250 infected participants aged 30 and older to receive a 14-day course of montelukast (10 milligrams daily) or placebo from Jan. 27 to June 23, 2023, a period dominated by SARS-CoV-2 Omicron subvariants.
The ongoing ACTIV-6 platform trial assesses repurposed drugs for COVID-19 outpatients.
On day one of the study, 3.7%, 33.2% and 61.0% of participants reported no, mild, or moderate symptoms, respectively. They were enrolled within a median of four days of symptom onset and received montelukast or placebo within a median of five days.
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Why Big Pharma Refuses to Take on the Threat of Antibiotic-Resistant Germs
Millions of people could die from antibiotic-resistant germs in the near future. But there are very few new antibiotics in the research pipelines of the big pharmaceutical companies, which are focused on developing more profitable drugs. What is behind this blatant injustice — and what can be done about it?
Some 40 million people will die from antibiotic-resistant germs in the next 25 years, according to the latest estimate. All reasonable experts agree: New medicines must be developed urgently, otherwise we will face the threat of living in a post-antibiotic era, an era in which people die from simple infections because doctors can no longer treat them.
Yet although the problem and solutions are obvious, there are very few new antibiotics in the research pipelines of the big pharmaceutical companies. More and more companies are even closing down their antibiotics divisions. The reason? Antibiotics are not profitable.
Companies will rather focus on another cancer drug that marginally improves the prognosis for lung cancer; another cholesterol-lowering drug that is slightly more effective than its predecessor and is so inexpensive to develop that it brings in billions without any major risks; or yet another anticoagulant.
And so billions of dollars in development costs are spent on drugs that have little impact on people’s health, while virtually nothing is spent on developing drugs that could save millions of lives. It is a blatant injustice.
Survey: Only a quarter of US adults concerned about RSV, down from 35% in 2023
Just 26% of U.S. adults say they are concerned that they or a family member may be infected by respiratory syncytial virus (RSV) in the next three months, down from 35% last year, while the proportion worried about COVID-19 and flu stayed the same, according to the latest health survey from the Annenberg Public Policy Center (APPC) at the University of Pennsylvania.
“It is possible that memories of last year’s winter holiday surge in respiratory illnesses and of the 2022-23 ‘tripledemic’ of COVID-19, flu, and RSV respiratory viruses have faded,” Kathleen Hall Jamieson, PhD, director of the APPC and survey director, said in a press release.
The results show an increasing awareness of the importance of RSV vaccines for infants, according to Laura Gibson, PhD, an Annenberg senior data analyst. “If this translates into increased immunization rates, we could reduce their hospitalization rates,” she said.
Merck Says Experimental RSV Treatment Protected Infants in Trial, Paving Way for Potential Approval
Merck on Thursday said its experimental treatment designed to protect infants from respiratory syncytial virus (RSV) showed positive results in a mid- to late-stage trial, bringing the company one step closer to filing for approval of the shot.
The pharmaceutical giant could emerge as a new competitor in the market for treatments against RSV, which causes thousands of deaths among older Americans and hundreds of deaths among infants each year. Complications from the virus are the leading cause of hospitalization among newborns, making Merck’s drug a valuable new treatment option if approved.
Merck plans to discuss the study data with regulators worldwide, with a goal of making the treatment available for infants as early as the 2025 to 2026 RSV season, according to a release.
The trial examined the safety and efficacy of a single dose of the treatment, clesrovimab, in healthy preterm and full-term infants entering their first RSV season. Merck presented the results at the medical conference IDWeek in Los Angeles.
NIH Study Shows Bavarian Nordic’s Mpox Shot Elicits Immune Response in Teens
With the clade 1 outbreak of mpox (formerly monkeypox) raging through the Congo and other countries in Central Africa, younger people have become markedly vulnerable to infection.
While Bavarian Nordic’s vaccine Jynneos is approved in several countries to prevent mpox and smallpox infections in adults, there has been a lack of data to support its approval in adolescents. But that is beginning to change as interim results of a trial of Jynneos in teenagers indicate that it is safe and elicits a comparable immune response as seen in adults.
Earlier this week, based on results from a 2023 study, the World Health Organization announced the prequalification of Jynneos for adolescents ages 12 to 17.
