The China Food and Drug Administration (CFDA) has limited the use of pidotimod, an immunostimulant frequently prescribed to children, after experts publicly questioned the drug’s safety and effectiveness.

The announcement comes in the context of perceptions that doctors in China sometimes prescribe unnecessary treatments for kickbacks from pharmaceutical companies, and public concerns about the efficacy and safety of medications — even those approved by the CFDA.

Pidotimod, which is sold under different names by several manufacturers, is often prescribed by pediatricians, ENT doctors, and dermatologists in China to treat various infections, and even colds or diarrhea, in young children.

But on Friday, the CFDA ordered pharmaceutical companies to update usage instructions for pidotimod: The new directions must clarify that the drug can only be prescribed as supplementary medication to adults and children over 3 years old, and for no more than 60 days. The drug is also no longer endorsed for treatment of acute infections, ENT infections such as rhinitis, or gynecological infections.

Polichem, the pharmaceutical company that originally developed pidotimod, told Sixth Tone in a statement that they will update the product’s package inserts accordingly.

Wang Yuedan, the associate director of the Department of Immunology at Peking University, told Sixth Tone that the changes were important: “There is no solid proof that pidotimod should be used for children under 3, and we should be especially careful when prescribing drugs for this demographic.” While some parents believe that pidotimod can be taken to strengthen a child’s overall immunity, Wang said, there is no drug that can improve the immune system long-term.

Pidotimod first appeared on the market in Italy in 1993 and has been used in China for more than a decade. Between 2015 and 2017, the medication was prescribed more than a million times for children in China, and 150,000 times to adults. According to The Paper, Sixth Tone’s sister publication, annual sales of the drug are estimated to be worth 300,000 to 500,000 yuan ($47,000 to $79,000).

But skeptical voices began chiming in last December, when Ji Lianmei, a pharmacist from Beijing’s United Family Healthcare, published an article saying that after combing through available research, it seemed pidotimod had not gone through rigorous, large-scale clinical tests for all uses and age groups. She also questioned whether the drug was effective for some of its prescribed applications, such as ENT and gynecological infections.

“The price of a box varies from dozens of yuan to more than 100 yuan. What’s more, it’s often prescribed in a one-month supply, or for a treatment course that lasts three months,” Ji wrote. “No wonder doctors are in favor of this drug!”

The article touched a nerve with many because of public concerns that China’s health sector is rife with overprescription and kickbacks. Distrust even extends to the CFDA: In the early days of the administration, which was established in 1998, pharmaceutical companies are believed to have bribed officials for approvals.

Though in recent years the CFDA has become more professional and rigorous in its approval procedures, some people still have doubts about the efficacy and safety of medications approved in the past.

In response to skeptics, Polichem emphasized that pidotimod has been approved in 23 countries worldwide under strict standards, and more than 3 million patients have used the drug, including 2.5 million children. Of the compendium of clinical research, 17 studies involving over 1,400 patients are from China. The company has also promised to collect further clinical information and develop improved guidelines for both patients and physicians.

Last year, the CFDA ordered Shapuaisi, a popular over-the-counter eye drop brand, to conduct clinical trials to prove its efficacy after the manufacturer was slammed for exaggerating the product’s impact in advertisements.

Editor: Qian Jinghua.

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