Alprazolam

Both recalls were graded Class II, suggesting that use of the suspect meds could lead to temporary or reversible negative health effects. Viatris and Teva Pharmaceutical Industries recently launched separate recalls in the U.S. related to dissolution problems for a common anxiety medication and concerns around an unapproved raw material in a high blood pressure patch, respectively.Both recalls were graded Class II, suggesting that use of the suspect meds could lead to temporary or reversible negative health effects. In both instances, the FDA determined that the probability of serious health risks to patients was remote.In the case of Viatris, the drugmaker is pulling (PDF) one lot of extended release Xanax tablets, citing failed dissolution specifications, which concerns (PDF) how drugs are broken down to release their active ingredients in the body. The recall pertains to 3-mg tablets in 60-count bottles that were produced in Ireland and distributed across the U.S. via Viatris Specialty in Morgantown, West Virginia, according to the FDA report. Viatris initiated the recall on March 17. The action concerns a batch that was slated to expire at the end of next February.The Xanax XR recall is “specific to one lot of one strength (3mg) of the brand product only, and 51 bottles were distributed to U.S. wholesalers between Aug 27, 2024, and May 29, 2025,” a Viatris spokesperson said in an emailed statement. “No other batches of the Xanax XR brand product, or its generics, are impacted,” the spokesperson added, clarifying that the “vast majority of patients in the U.S. are dispensed generic alprazolam, which this recall does not affect.”The product pull is being carried out “at the retailer level, as agreed with the FDA, meaning that patients do not need to take any action,” according to the company representative. As for Teva, the branded and generic drugs hybrid is yanking multiple lots of its clonidine transdermal system across 0.1-, 0.2- and 0.3-mg/day dosage forms, separate entries on this week’s FDA enforcement report note. Teva’s medication-delivering patch is cleared for treatment of high blood pressure, and it is also used off label for other conditions like ADHD and anxiety, Quartz reports.The clonidine patch batches were produced by Actavis Laboratories UT in Salt Lake City, with the pull coming down to good manufacturing practices deviations tied to the use of an “unapproved raw material,” the FDA’s report reads. Last Month, the California State Board of Pharmacy released a dispatch (PDF) noting that the concerns around the raw material were linked to a “lack of extractable and leachable data for the unapproved raw material to establish safety of the drug product.” The alert acknowledged that Teva’s own toxicological evaluation and health hazard assessment found that the product was unlikely to cause serious health issues and that the overall risk of harm to patients was “considered not applicable.” Teva launched its ongoing recall on March 19, moving to pull seven total batches slated to expire as soon as this month and as late as next May.  Teva’s action follows an unrelated blood pressure med recall late last year. In November, the company withdrew more than 500,000 bottles of the widely-used drug prazosin hydrochloride, citing higher-than-acceptable levels the cancer-linked impurity N-nitroso prazosin during deviation testing. Nitrosamines, many of which are carcinogenic, are a group of compounds that can form under a variety of conditions, including during the storing or manufacturing of drugs. 

Though opioid use is a widespread crisis across the United States, the pharmaceutical industry has long neglected to develop new treatments.\n While the opioid epidemic is one of the most urgent public health emergencies facing the U.S., new therapeutic approaches for treating the underlying substance use disorder have lagged far behind. Scientists have now used an artificial intelligence program to design a compound that reduced fentanyl use in addicted rats, which could one day serve as a new tool to help patients recover from opioid abuse.California-based company GATC Health used an AI platform called Operon to scan through data from the brains of people who had lived with opioid use disorder for potential drug targets. The model homed in on two serotonin receptors and then repeatedly crafted better and better molecules that can bind to them, according to a new research paper.A team led by Christie Fowler, Ph.D., a neuroscientist at the University of California, Irvine, then tested the ability of the two most promising candidates to reduce opioid use in rats addicted to the drug. One compound in particular, GATC-1021, was able to cut cravings for opioids in the rodents with no noticeable behavioral or physical side effects.The results were published in the Proceedings of the National Academy of Sciences.Fowler was skeptical of the AI model at first, she told Fierce Biotech, “as I think any good scientist is.”“But once we started testing the compounds in our lab,” she added, “we were pleasantly surprised that they worked.”She also heralded the model’s potential to speed up the famously lethargic drug development process. Rather than starting with 50 compounds to test, as she’s used to, her team only had to work with two.GATC-1021 targets two serotonin receptors, 5HT2A and 5HT6, which, when targeted alone can produce hallucinogenic effects. But Fowler’s team noticed no such psychedelic effects of GATC-1021, likely because the AI model had fine-tuned the degree to which the compound engaged each receptor.Currently, the standard drugs used to address opioid use disorder are themselves opioids, which adds to the stigma around addiction and makes accessing treatment challenging. The most common opioid used in this harm reduction approach is methadone, which has existed since the 1960s.“What if you had to go somewhere, wait in a line, stand there while you\'re dosed, and do that every single morning of your life?” Stephen Loyd, M.D., an internal medicine and addiction medicine physician at Cedar Recovery in Tennessee, told Fierce. “If you had a tool that didn\'t carry that baggage, it\'s not only a needle changer, it is a paradigm shifter.” In addition to not being an opioid, Fowler’s team also found that GATC-1021 promoted the growth of new connections between neurons in the rats’ brains in regions associated with learning and memory. This neuronal refreshing in the brain may help break the entrenched behavioral patterns that fuel addiction.“Drug use is a really complicated thing that begins as this high level of reinforcing behavior, but then you get a lot of learned associations that\'s really propagating relapse,” Fowler explained. For example, someone in recovery from alcohol use disorder may develop a craving to drink after walking by a bar that they used to frequent.By altering the brain’s architecture itself, GATC-1021 could not only stave off cravings but also help patients break these behavioral cycles that often trigger relapse. Loyd called this potential a “quantum leap” in addiction treatment.“The longer you can keep somebody in the recovery process, the better their long-term outcomes,” said Loyd, who has himself been in recovery from opioid use for more than 20 years after becoming addicted to OxyContin and Xanax during the final year of his internal medicine residency.“What makes GATC-1021 so compelling is that it was designed from human data to target the specific neurological drivers of opioid dependence, rather than simply substituting one opioid for another,” Rahul Gupta, M.D., president of GATC Health and former director of the White House Office of National Drug Control Policy, said in a press release shared with Fierce. “That level of precision is only possible through AI, and it represents a fundamentally new way to think about treating this disease.”Fowler’s team put together a robust preclinical package for GATC-1021, and the plan now is to move forward with an investigational new drug application and clinical trials, she told Fierce. Fowler hopes to also test the compound’s potential in other addictions and psychiatric diseases, too, given the similar mechanism underlying the conditions.To Loyd, who was not involved with the work but had previously met GATC Health’s leadership at a conference in Washington, D.C., the company is doing important work in a patient population that has long been neglected by the pharmaceutical industry.“Industry has shown no interest in this field other than pain medication,” he said, noting stigma against addiction and the difficulty of reaching patients as key reasons why. But the potential impact of a new opioid addiction treatment is huge, as the disease does not discriminate.“You\'re talking about millions and millions of lives,” Loyd said. “I don\'t think they understand the scope of the market.”