Main  //  Safety  //   New safety of medicinal preparations
The purpose of this section is to familiarize health care workers and pharmaceutical industry professionals with important changes in safety profile of medicinal preparations, new safety warnings as well as recommendations for prevention of pharmacotherapy complications.
Date Name Description Download
01.12.2017 Azithromycin, clarithromycin, erythromycin, roxithromycin Risk acute generalized exanthematous pustulosis download
01.12.2017 Pramipexole Risk dystonia download
01.11.2017 Mesalazine Risk of photosensitivity reactions download
01.11.2017 Prednisolone Induced scleroderma renal crisis download
01.10.2017 Amoxicillin Risk drug reaction with eosinophilia and systemic symptoms (DRESS) download
01.10.2017 Erythropoietin Risk severe cutaneous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis download
01.09.2017 Gadolinium Restrictions on the use of linear gadolinium agents because of accumulation gadolinium in the brain download
01.08.2017 Humira (Adalimumab) Risks during treatment with TNF inhibitors therapy, including adalimumab (Humira®) and measures to minimize the risks download
01.07.2017 Brentuximab vedotin Risk cytomegalovirus (CMV) reactivation download
01.07.2017 Gabapentin Risk respiratory depression without concomitant opioid use download
01.06.2017 Vancomycin New recommendation to prescribing information for vancomycin antibiotics download
01.06.2017 Leflunomide Falsely decreased values ionized calcium levels download
01.05.2017 Herceptin (Тrastuzumab) Reminder of importance of cardiac monitoring download
01.05.2017 Loperamide Serious cardiac events with high doses of loperamide from abuse and misuse download
01.04.2017 Zelboraf (Vemurafenib) Risk of Dupuytren’s contracture and plantarfascial fibramatosis with Zelboraf download
01.04.2017 Cotellic (Cobimetinib) Additional cases of severe haemorrhage reported with Cotellic (Cobimetinib) download
01.04.2017 Fluconazole Risk spontaneous abortion and stillbirth download
01.03.2017 Beclomethasone and other corticosteroids Risk interaction with CYP3А inhibitors download
01.03.2017 Azacitidine Risk of pericarditis and pericardial effusio download
01.03.2017 Propofol Valproate - pharmacokinetic drug interaction leading to an increased propofol exposure download
01.02.2017 Proton pump inhibitors (PPIs) Risk of gastric polyps download
01.02.2017 Methylphenidate Risk of priapism download
01.02.2017 Phenindione Risk of calciphylaxis download
09.01.2017 Direct-acting antivirals for hepatitis C Risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C download
01.11.2016 Levonorgestrel for the emergency contraceptive New recommendations when levonorgestrel is taken together with certain interacting medicines download
24.10.2016 Levonorgestrel intrauterine delivery systems Risk of uterine perforation download
21.09.2016 Proton pump inhibitors Risk of elevated circulating levels of Chromogranin A download
21.09.2016 Warfarin Risk of calciphylaxis download
18.08.2016 Loperamide Warns about serious heart problem with high doses of the antidiarrheal medicine download
21.07.2016 Fluoroquinolone Restriction of the use for patients with acute sinusitis, bronchitis and uncomplicated urinary tract infections download
09.06.2016 Inhaled corticosteroids EMA has completed a review of inhaled corticosteroids for chronic obstructive pulmonary diseases download
08.06.2016 Olanzapine Risk of rare serious skin reaction (DRESS) download
05.05.2016 Vismodegib Risk of premature fusion of the epiphyses (growth plates) download
26.04.2016 BCR-ABL tyrosine kinase inhibitors Risk of reactivation of hepatitis B virus download
19.04.2016 Fusafungine Marketing authorization for fusafungine-containing medicines be revoked download
13.04.2016 Opioids Warns about several safety issues with opioid pain medicines download
24.03.2016 Inhaled corticosteroids Risk of pneumonia in patients who take inhaled corticosteroids medicines to treat chronic obstructive pulmonary diseases download
10.02.2016 Iodine containing contrast agents Rare cases of underactive thyroid in infants download
12.01.2016 Tarceva (Erlotinib) First line maintenance treatment not demonstrating benefit in patients whose tumors do not harbor an EGFR-activating mutation download
04.01.2016 Xalkori (Crizotinib) Inclusion of a new warning regarding cardiac failure download
04.12.2015 Mycophenolate Serious risk of teratogenicity – important new pregnancy prevention advice for women and men download
17.11.2015 Ikorel (Nicorandil) Do not use as the first-line treatment for angina; risk of ulcerations and progression to complications download
09.10.2015 Betmiga (Mirabegron) New recommendations about the risk of blood pressure download
16.09.2015 Dacogen (decitabine) Change in instructions for reconstitution and storage download
15.09.2015 Bioparox (Fusafungine) New contraindications and recommendations to minimize the risk of serious allergic reactions download
17.08.2015 Prolia (denosumab) Clinically significant cases of hypercalcemia after cessation of treatment with denosumab in pediatric patients download
02.07.2015 Ceftriaxone Dosing recommendation to children download
15.06.2015 Ibuprofen-containing medicines Small increase of cardiovascular risk with daily doses at or above 2400 mg download
04.05.2015 Hydroxyzine-containing medicines New measures to minimize the risk of effects on heart rhythm download
06.04.2015 Chlorhexidine solutions Risk of chemical injury including burn when use in skin disinfection in premature infants download