Comunicazione concordata EMA-AIFA su carenza Xofigo® (06/11/2014)
L’Agenzia Europea dei Medicinali e l'Agenzia Italiana del Farmaco comunicano aggiornamenti relativi alla carenza temporanea di Xofigo® (radio-223 dicloruro).
Italiano
L’Agenzia Europea dei Medicinali e l'Agenzia Italiana del Farmaco comunicano aggiornamenti relativi alla carenza temporanea di Xofigo® (radio-223 dicloruro).
Use of recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
The possible pharmacological mechanism
The risks related to influenza infection in pregnant women have been recognised for a long time.1 The pandemic of the virus A/H1N1 in the 2009-2010 season was no exception: pregnant women were at greater risk of contracting a severe form of A/H1N1 influenza than the general population, and those who contracted the infection had a higher frequency of adverse pregnancy outcomes than those who did not contract the virus.2,3 Although the safety data are limited, pregnant women were included in the priority categories in the vaccination programmes against A/H1N1.
The effects on the central nervous system
Self-care is not always effective, and this does not only apply to medication wrongly taken because it is left over from old prescriptions, or discontinued or changed in an arbitrary and inappropriate manner, but also self-medication or do-it-yourself medicines. Modern medicine is often excessive and increasingly leads to people taking medication without clear prescriptive instructions.
Use of this defective Formalin may prevent or delay diagnoses and treatment decisions.
Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries and psychiatric problems. Undeclared drug ingredients may also cause serious side effects when combined with other medications.
When a medicine is marketed, much is known about its quality and pharmacology and in its efficacy in a carefully screened group of patients in clinical trials. These data, however, may provide an incomplete and even misleading account of the drug’s effectiveness in the community at large. Even less is known at the time of marketing approval about its safety in the general population, because of the size of the clinical trials and the selected nature of the subjects included. In other words, its overall benefit-risk balance is uncertain.
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