Patients were brought to the kidney – Newspaper Kommersant No. 140 (7341) dated 08/04/2022

Russian pharmacies have run out of the urological drug Driptan, which is necessary for children with injuries and tumors of the spine and dysfunction of the bladder. In the American Abbott (manufacturer of the drug), “Kommersant” explained the interruptions by “updating production processes.” The company informed about the suspension of Driptan imports until the second quarter of 2023, Roszdravnadzor specified. The parties make it clear that the situation is not related to anti-Russian sanctions. Driptan is the only drug allowed according to the instructions for patients under 14 years of age, so tens and hundreds of thousands of children may be left without treatment, doctors and the patient community warn. Experts add that the proportion of minors with chronic kidney disease and severe urinary incontinence could rise. Dmitry Morozov, chief freelance surgeon of the Ministry of Health, recalled that the appointment of analog drugs is possible by decision of the medical commission.

In July, the urological drug Driptan (oxybutynin) of the American Abbott disappeared from pharmacies in Moscow and the Moscow region, St. This was announced by the founder of the fund for helping children with congenital spina bifida (spina bifida) “Spina bifida” Inna Inyushkina.

Driptan is the only drug that, according to the instructions, is allowed in pediatric practice for the treatment of intravesical hypertension (increased pressure in the bladder), says Anna Shchedrina, a pediatric urologist-andrologist, a member of the Spina Bifida council at the University Hospital of St. Petersburg State University. She clarifies that such problems arise not only in patients with spina bifida, the number of which, according to the Spina Bifida Foundation, in the Russian Federation can reach 5 thousand. Driptan is necessary for children with injuries of the spine, spinal cord, spinal tumors, organic lesions and functional bladder disorders, including enuresis. According to Anna Shchedrina, we can talk about tens and even hundreds of thousands of patients.

There is nothing to replace Driptan, Ms Shchedrina warns. Since drugs of similar action are not allowed or expressly prohibited by the instructions for use in children, they will have to be prescribed off label, only after hospitalization in a specialized hospital or by decision of the medical commission. Inna Inyushkina adds that these drugs have a lot of side effects, and the fund, according to her, is already receiving complaints about them from parents. Another alternative, Anna Shchedrina points out, is surgery. If the pathology of the bladder is not eliminated, the urologist continues, the upper urinary tract will suffer, followed by the kidneys, which will lead to chronic renal failure and death of the patient. “In children who are already receiving Driptan, the functions of the bladder have been corrected. Deprived of the drug, they will roll back in their state. It’s like taking insulin away from a diabetic child. The quality of life of such patients will deteriorate sharply, the percentage of children with chronic kidney disease and severe forms of urinary incontinence will increase,” states Ms Shchedrina.

The chief freelance pediatric surgeon of the Ministry of Health of Russia Dmitry Morozov, however, notes that “in general, there are few patients in the world who are indicated for this particular drug.” “At the same time, there are group analogues of this drug, including those produced in Russia, with a similar effect. They are allowed from an older age: two drugs can be used from 18 years old and one more from 14 years old. For children under 14 years of age, the appointment of group analogues is possible by decision of the medical commission, ”said Mr. Morozov to Kommersant.

According to Roszdravnadzor, as of August 1, 2022, 18,812 packs of Driptan are in civil circulation in the regions. At the same time, Kommersant was told in the supervisory service that Abbott informed about the suspension of the import of the drug into Russia until the second quarter of 2023. “Kommersant” got acquainted with the letter of the head of Roszdravnadzor Alla Samoilova to the regions dated July 26. Ms. Samoilova reports that the company has decided to suspend the circulation of Driptan of the last released series “due to the need to conduct additional tests of this series of the drug for compliance with the requirements of regulatory documentation in terms of “Related impurities””. The territorial bodies of Roszdravnadzor were instructed to “ensure control over the identification and withdrawal from circulation” of the indicated series of Driptan.

Abbott told Kommersant that the “temporary” absence of the drug is due to “the necessary updating of production processes”, and recommended that patients consult a doctor for alternative therapy. “We are working to resume deliveries as soon as possible in order to continue to meet the needs of patients,” the company assured.

Note that Abbott issued a statement on March 14 announcing the suspension of non-essential business activities in Russia, including all new investments, business development and advertising due to a special operation in Ukraine. At the same time, the company assured that the supply of medicines will continue. “As a medical company, we have an important goal, which is to preserve and restore health and save lives. We do this in over 160 countries. Health products, including food, medicines and medical supplies, are generally not subject to sanctions for humanitarian reasons,” the statement said. According to Kommersant’s information, Abbott has not withdrawn any other drug (including for cancer) from Russia.

DSM Group CEO Sergey Shulyak admits that Abbott specialists, “given their compliance (adherence to therapy) and based on new research data,” decided to double-check Driptan. “It is the claims of patients that do not matter much here. In the West, lawsuits and claims are multi-million dollar fines. Therefore, with any suspicion of possible damage to the reputation or risk to the health of patients, the company could recall a series of the drug, ”says Mr. Shulyak. At the same time, he continues, if the matter is really “in additional control”, the situation will not change until the company conducts the necessary research.

At the same time, Anna Shchedrina emphasizes that the drug has been used in Russia since the late 90s and has proven itself well, including in Russian clinical trials. Before its advent, small patients died from urinary infections and other complications. “Now these children have the opportunity to fully live and socialize in society. And we risk simply losing this opportunity,” Ms. Shchedrina warns. Dmitry Morozov is optimistic: “I am sure that the supply of this drug to the Russian Federation will continue,” he told Kommersant. “However, we need to create our own drug, oxybutynin hydrochloride. Currently, there are examples of active import substitution of the drug for the treatment of monosymptomatic enuresis – minirin (manufacturer Switzerland) for the domestic drug – Antiqua Rapid (Pharmstandard).

Natalya Kostarnova