New side effects of gemcitabine drugs

On the portal of the State Register of Medicines, the Ministry of Health of the Russian Federation published a letter with recommendations for making changes to the general characteristics, instructions for use, and leaflets of medicines containing gemcitabine in parenteral dosage forms (injection: under the skin, into a muscle, or into a vein). 

Gemcitabine is a powerful cancer-fighting chemotherapeutic agent. The principle of action is that the substance is embedded in the DNA of cancer cells and stops their division, which eventually leads to death. Gemcitabine is used to treat lung, breast, bladder, renal pelvis, ureters, urethra, ovaries, pancreas, and cervical cancer. 

In order to increase the safety of patients using medications with gemcitabine, the list of potential side effects has been expanded. 

Information should be added about the possibility of developing life—threatening Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. These are life-threatening and painful allergic reactions that cause extensive damage to the skin and mucous membranes, most often due to taking medications. 

Consumer documentation should also be supplemented with information on mandatory patient information about possible manifestations of these conditions, careful skin monitoring in order to notice any changes in a timely manner and, if symptoms appear that may indicate the development of these conditions, cancel the drug in a timely manner. 

The regulator also recommends adding such undesirable reactions as shortness of breath, cough and rhinitis, bronchospasm, interstitial pneumonitis, decreased blood pressure, peripheral vascular vasculitis, gangrene, pulmonary edema and adult respiratory distress syndrome.