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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
01.02.2017 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
12.03.2015 Ambroxol and broAmbroksol.rtfmhexine Risk of severe allergic reactions and severe cutaneous adverse reactions download
05.02.2015 Valproate Strengthen warning on the use of valproate medicines in woman and girls download
19.01.2015 Coraxan (Ivabradine) New contraindication and recommendations to minimize risk of cardiovascular events and severe bradycardia download
19.01.2015 Eligard (Leuprorelin acetate) Risk of lack of efficacy due to incorrect reconstitution and administration process download
01.12.2014 Bromocriptine Restricted use of bromocriptine for stopping breast milk production download
06.11.2014 Diacerein-containing medicines CMDh endorsed the final recommendations to restrict the use of diacerein-containing medicines download
15.10.2014 Cladribine According to the results of clinical trials of cladribine in patients with multiple sclerosis was identified an increased risk of malignancies, severe lymphopenia, immunosuppression. Benefit-risk ratio of the use of cladribine for multiple sclerosis evaluated as unfavorable download
09.10.2014 Simulect (Basiliximab) Warning against off-label use in cardiac transplantation download
10.09.2014 Ikorel (Nicorandil) Risk of serious ulcerations and perforations download
15.08.2014 Domperidone-containing medical products Should only be used to relieve symptoms of nausea and vomiting download
15.07.2014 Bromocriptine Re-evaluation of the benefit-risk ratio due to risk of cardiovascular adverse events download
04.06.2014 Coraxan (ivabradine) Preliminary results of the SIGNIFY study download
04.06.2014 Renin-Angiotensin system (RAS) EMA has endorsed restrictions on combining different classes of medicines that act on the renin-angiotensin system (RAS) download
01.05.2014 Дилатренд (Carvedilol) Risk of severe cutaneous adverse reactions download
04.04.2014 Bivalos (Strontium ranelate) New restricted indication and monitoring recommendations for the use download
01.04.2014 Domperidone containing medicines EMA Recommends restricting use of Domperidone download
10.03.2014 Zelboraf (Vemurafenib) Risk of liver injury download
10.03.2014 Paracetamol (acetaminophen) To reduce the risk of severe liver injury related to intake of paracetamol (acetaminophen) in combination drug products in doses exceeding the recommended daily doses, the amount of paracetamol per dosage unit should be decreased to the level not more than 325 mg. download
06.02.2014 Capecitabine Risk of severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis download
06.02.2014 Temozolomide Risk of severe liver toxicity download