Guaifenesin

New Delhi: The Rajasthan government has said claims of a 5-year-old child’s death allegedly caused due to a cough syrup is inconsistent with facts and a drug test to confirm the root cause of the tragedy is awaited. The cough syrup allegedly linked to the death of the child in Rajasthan’s Sikar district was neither prescribed by the attending doctor nor supplied to the Community Health Centre (CHC) in the district, a senior state health ministry official involved in the investigation told ETPharma. “Based on the initial probing we found that the cough syrup identified as Dextromethorphan linked with the death of a child was neither prescribed by the doctor and nor the medicine has been supplied to the Jhunjhunu district,” said the senior state government official on grounds of anonymity. Additionally, the child and his family members did not visit the Community Health Centre (CHC) on September 26, the date on which he is reported to have received and consumed the syrup, the official added. Earlier this week multiple reports outlined that, a child identified as Nityansh Sharma from Sikar district fell ill and subsequently died after consuming Dextromethorphan Hydrobromide syrup obtained from Chirana Community Health Centre (CHC) under the state's free medicine scheme "Mukhyamantri Nishulk Dava Yojana.” A day after the incident another three-year-old child in the state’s Bharatpur district is reported to have experienced similar complications after allegedly consuming the same syrup. However, according to the official, under the state government’s free medicine scheme the Dextromethorphan syrup is “not supplied to Jhunjhunu district” so the claim of obtaining the medicine from there is not consistent with facts. Bharatpur and Sikar are part of Jaipur Division, while Chirana is a village situated in Nawalgarh Tehsil of Jhunjhunu district in Rajasthan. Soon after the incident came to light, State Health Minister Gajendra Singh Khimsar ordered a probe to investigate the safety of medicine. Without disclosing the medicines prescribed to the deceased, the official quoted above said, “the child visited a doctor on September 22 and the prescription does not include Dextromethorphan.” The official said that the medicine was supplied to “several districts.” However, the case is linked to a particular batch, samples of which have been collected and sent to the state drug testing laboratory for analysis. According to the official, certain side effects of Dextromethorphan, such as dizziness and vomiting, are common and may be aggravated in cases of overdose or when taken alongside multiple medicines. “In this case (Nityansh), we cannot confirm that the death was caused by the cough syrup, as the family did not allow a post-mortem examination and before arriving on any conclusion here we are awaiting for the drug test report,” he said. Meanwhile as a precautionary measure, the supply and distribution of “all other batches of the drug have been halted across the state," it added. To expedite the investigation, the official stated that the laboratory test, which usually takes “8-10 days’, has been fast-tracked, and the report is expected by “tomorrow”, i.e. October 2, 2025 Calls made by ETPharma to Rajasthan State Drug regulatory officials remained unanswered. The state government has constituted a three-member committee to assess the test findings and decide on subsequent measures. Regarding any punitive action against the cough syrup manufacturer, Kayson Pharma, the official said that state authorities are preparing a notice to be sent to the company. However, any “strict action” will be taken only after the test report is received. While the official refrained from commenting on the purported manufacturing concerns related to the matter it explained that, “the procurement for the state’s free medicine scheme is overseen by the Rajasthan Medical Services Corporation Limited (RMSC) and all drug batches undergo quality testing in NABL-certified labs before being supplied for distribution to various CHCs.” Notably, in June 2023 the Central Drugs Standard Control Organization (CDSCO) had banned several Fixed-Dose Combinations (FDC) of Dextromethorphan citing "safety and quality concerns" with the drugs. The list includes several FDC combinations marketed as a syrup for cough such as Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol; Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride, among several others. The drug linked with the case in Rajasthan involves a single ingredient: "Dextromethorphan." By Abhijeet Singh ,

Dive Brief:Axsome Therapeutics gained more than $1 billion in market value Monday, after the brain drug developer disclosed a patent settlement with Teva Pharmaceuticals that will keep a generic copy of Axsomes top drug at bay in the U.S. until at least 2038.Axsome had sued Teva for patent infringement when the generic drugmaker filed for approval of a knock-off version of Auvelity, a medicine for major depressive disorder that last year earned Axsome some $290 million in net sales.Per the settlement struck by the two companies, Teva will gain a license to sell generic Auvelity on or after March 31, 2039, should Axsome gain regulatory exclusivity for pediatric use of the drug. If Axsome doesnt, Teva can enter the U.S. market with its copy on Sept. 30, 2038.Dive Insight:Auvelity is one of three drugs Axsome sells and by far the companys top product.Auvelity combines a form of dextromethorphan, which is used as a cough suppressant in drugs like Robitussin, and bupropion, an antidepressant compound that on its own was previously marketed as Wellbutrin.The New York-based biotechnology company also markets Sunosi, a treatment to improve wakefulness in people with narcolepsy or obstructive sleep apnea, and Symbravo, a migraine medicine that U.S. regulators approved last month.The patent settlement with Teva will ensure Auvelity remains a contributor to Axsomes business for years to come, and removes the threat of Teva entering the market earlier. The biotech has a large tranche of Auvelity patents that expire in 2034, which would have been the next line of defense if Teva had succeeded in challenging Axsomes later-dated patentsThe settlement also provides for the termination of all litigation between Axsome and Teva over Auvelity patents that was pending in the New Jersey district court. The companies will submit their agreement to the Federal Trade Commission and the Department of Justice for review.We see this as a material win for Axsome, wrote Myles Minter, an analyst at William Blair, in a client note. Graig Suvannavejh, an analyst at Mizuho Securites, took a similar view, calling the settlement a significant positive for the company.Investors seemed to agree, pushing Axsome shares up by 23% through mid-morning Monday. Part of those gains may be expectations the settlement will put Axsome higher on pharmaceutical companies lists of deal targets.Staying generic entry with this settlement favorably positions the company if there is a potential M&A buyer for Axsome, in our view, wrote Minter.Theres some recent precedent for this line of thinking. Intra-Cellular Therapies patent settlement with Sandoz for its drug Caplyta was one item Johnson & Johnson reviewed before finalizing a $14.6 billion buyout of Intra-Cellular, recently filed regulatory documents show. '