Russian pharmacies have run out of the urological drug Driptan (oxybutynin), which is necessary for children with injuries and tumors of the spine and dysfunction of the bladder. The drug will not appear until the spring of 2023, while there is nothing to replace Driptan for children under 14 years of age. Kommersant writes about this with reference to Inna Inyushkina, the founder of the Spina Bifida Fund for Helping Children with Congenital Spina Bifida, the American drug manufacturer Abbott and Roszdravnadzor.
Abbott attributed the outages to "upgrading manufacturing processes." Both Roszdravnadzor and the company note that the absence of the drug is not related to anti-Russian sanctions.
Anna Shchedrina, a pediatric urologist-andrologist, a member of the Spina Bifida council at the University Clinic of St. Petersburg State University, told the publication that Driptan is the only drug approved according to the instructions for patients under 14 years of age for the treatment of intravesical hypertension (increased pressure in the bladder). Driptan is also necessary for children with injuries of the spine, spinal cord, tumors of the spine, organic lesions and functional disorders of the bladder, including enuresis. Shchedrina believes that we can talk about tens or hundreds of thousands of patients.
In addition, in children who are already receiving Driptan, "the functions of the bladder are corrected." According to Shchedrina, if they lose the drug, they will roll back in their condition. Therefore, the proportion of children with chronic kidney disease and severe forms of urinary incontinence may increase, warns Shchedrina.
Dmitry Morozov, Chief Freelance Pediatric Surgeon of the Ministry of Health of Russia, on the contrary, claims that “in general, there are few patients in the world who are indicated for this particular drug.” According to him, there are group analogues of this drug, including those produced in Russia, with a similar effect. But they are allowed from the age of 18, and one drug – from the age of 14. Prescribing analogues for children under 14 is possible only by decision of the medical commission, Morozov emphasizes.
According to Roszdravnadzor, as of August 1, 18,812 packages of Driptan are in civil circulation in the regions. The head of Roszdravnadzor, Alla Samoilova, sent a letter to the regions on July 26, in which she said that the company had decided to suspend the circulation of Driptan “due to the need to conduct additional tests of this series of the drug for compliance with the requirements of regulatory documentation for the “Related impurities” indicator.” Roszdravnadzor authorities were instructed to control the withdrawal from circulation of the indicated series of Driptan.
Abbott released a statement on March 14 that it was suspending non-essential business activities in Russia, including all new investments, business development and advertising, due to the war in Ukraine. Then the company assured that the supply of medicines would continue. Abbott has not withdrawn any other drug from Russia.
At the end of June, Kommersant reported that there was a shortage of subsidized drugs in hospital pharmacies: difficulties arose both with drugs more expensive than 700 rubles and with cheap drugs worth 200 rubles. Among the drugs that are most lacking are antiepileptic drugs, blood pressure lowering drugs, insulin and hypoglycemic drugs, “foreign effective” psychotropic drugs, drugs for the treatment of thyroid diseases.
This is not the first problem that the Russian pharmaceutical industry has faced since the start of the war. In May, the head of the scientific expertise of the pharmaceutical venture fund Inbio Ventures, Ilya Yasny, in a conversation with The Insider, said that Russia was running out of reagents for laboratory tests, and problems were coming with the production of medicines and disinfectants, in particular hydrogen peroxide.