Fever drug ADR allegation fans controversy
Shanghai. February 28. INTERFAX-CHINA - Drug safety is back in the public eye in China after media reports linked the fever drug nimesulide to a spate of adverse drug reactions (ADR) in children. China's leading manufacturer of the drug, Hainan Honz Pharmaceutical Ltd. (Hainan Honz Pharma), however, has denied the claims with support from government-backed experts.
Fever drug is a familiar euphemism for antipyretics.
Hainan Honz Pharma has alleged that its main competitor in the fever medicine market, Shanghai Johnson Johnson Pharmaceutical Ltd. (Shanghai Johnson Johnson), the China unit of U.S. pharma giant Johnson Johnson, has had a hand in spreading what it believes are unsubstantiated claims that nimesulide causes ADRs.
In November last year a senior doctor, addressing a pediatrics seminar in Beijing, said that his research had linked nimesulide to 4,703 ADRs in children in China from January 2004 to April 2010, including three fatalities. According to domestic media, the conference was sponsored by Shanghai Johnson Johnson.
The doctor's research findings were reported by a handful of television news outlets. But on Feb. 12 this year, after the well-regarded domestic newspaper 21st Century Business Herald questioned the use of the drug on children, the controversy was rekindled. Some drugstores in Shanghai and Chongqing municipalities were reported to have pulled the drug off shelves.
Hainan Honz Pharma has a lot at stake. The company leads the China market for nimesulide-based fever medicines with its Rui Zhi Qing brand. The product accounted for 73.01 percent of its total sales revenue in 2008 and 80.77 percent in 2009. However, Shanghai Johnson Johnson dominates China's overall fever medicine market with its acetaminophen-based Tylenol brand, and ibuprofen under the Motrin brand name.
The report by 21st Century Business Herald sent Honz Pharma's shares sliding on the Shenzhen Growth Enterprise Market (GEM), and on Feb. 14 the company moved to counter the claims, announcing that its Rui Zhi Qing brand has not been linked to any ADR cases since its market debut nine years ago. Meanwhile, the company lodged a complaint with Hainan Provincial Department of Industry and Commerce accusing Shanghai Johnson Johnson of unfair competition to attack domestic producers of nimesulide, which number more than 30, according to the State Food and Drug Administration (SFDA).
On Feb. 27, Hainna Honz Pharm announced that nimesulide had not been found to have any severe adverse effects, and threatened to initiate legal action against its accusers.
Nimesulide is strictly regulated in developed markets. In 2007 the European Medicines Agency (EMA) limited use of the drug on children to a maximum 15 day period and prohibited use by children under 12 years old, citing hepatotoxicity concerns. The drug has never been submitted to the U.S. FDA for evaluation.
"Most doctors in China's large hospitals do not use the drug on children at present," Wang Xiaoning, pediatrics director at Foshan No. 2 People's Hospital in Guangdong Province, told Interfax Feb. 25. Drugstores in China sometimes sell prescription medicines like nimesulide to non-prescription holders, and this might explain the ADRs, the doctor added.
The SFDA moved to quell worries on Feb. 18, saying the National Center for ADR Monitoring (NCAM) is conducting further appraisals of nimesulide.
Sun Zhongshi, a professor from the NCAM, told the Ministry of Health (MoH) newspaper Health News on Feb. 23 that research suggests severe ADRs or deaths linked to the drug were caused by overdose or overuse. He called for the media to exercise restraint, saying the findings of one study do not justify a recall.
"Following these comments from an SFDA official, the regulator might issue a circular confirming the drug's efficacy and warning of the risks, [but it is unlikely to issue a recall]. Investors will then likely regain confidence in Hainan Honz Pharma," Zhuang Yan, pharma analyst from Orient Securities, told Interfax on Feb. 28.
Hainan Honz Pharma's heavy reliance on nimesulide means a recall would hit it hard and only by leveraging the strength of its distribution network would