Current Drug Safety - Volume 5, Issue 4, 2010

Biotherapeutics are a burgeoning class of drugs that encompass three main categories of biopharmaceuticals. The first group includes early biotherapeutics such as insulin as replacement therapy, and more recently protein molecules such as the interferons. These represent equivalents to endogenous proteins and may therefore to a large extent be regarded, and recognised, as normal protein and not as foreign protein. Read More

Therapeutic monoclonal antibodies (mAbs) including antibody fusion proteins and antibody conjugates present an innovative class of (bio-)pharmaceuticals with increasing clinical importance. MAbs were initially perceived as comparatively safe drugs. As more mAbs appear on the market, characteristics of their safety profiles become apparent, including immunogenicity, i.e. the potential induced formation of huma Read More

Antibody formation is an intended physiological reaction to a “non-self” protein intentionally triggered in the case of vaccines. However, an unwanted immune response to a therapeutic protein may lead to a loss of efficacy and/or to severe side effects. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a multidisciplinary guideline providing general recomm Read More

The biopharmaceutical market has grown steadily since the early 1980s and today over 150 protein biopharmaceuticals have been approved for clinical use. These products often exhibit forms of immunotoxicity that often only come to light during clinical studies. The predictive value of animal studies and traditional in vitro screens is questionable, with few existing methods able to predict immunotoxicity in a way that is Read More

Protein therapeutics offer distinct advantages over other classes of drugs largely due to the high level of target specificity and generally low toxicity. Problems have, however, been encountered with some protein therapeutics inducing undesirable immune responses in patients. This immunogenicity can produce pleiotropic effects including the development of a high affinity B cell-mediated humoral response that is oft Read More

During the last few decades we have witnessed to a progressive deregulation of drug use and drug advertising. A good example of this process is the impressive number of medications which have been shifted from ‘prescription only’ to ‘over the counter’ status. Beyond economic interests on this status change (e.g. from pharmaceutical industry or health insurers) other less controversial motivations have been risen as argum Read More

Self-medication is defined as the selection and use of medicines by individuals (or a member of the individuals' family) to treat self-recognized or self-diagnosed conditions or symptoms. Several benefits have been linked to appropriate self-medication, among them: increased access to medication and relief for the patient, the active role of the patient in his or her own health care, better use of physicians and pharmacist Read More

Self-medication includes several forms through which the individual him/herself or the ones responsible for him/her decide, without medical evaluation, which drug they will use and in which way for the symptomatic relief and “cure” of a condition. It involves sharing drugs with other members of the family and social group, using leftovers from previous prescriptions or disrespecting the medical prescription either by Read More

Unlike most other drugs that only affect individual patients if used incorrectly for self-medication, misused antibiotics add to the global risk of increased spread of bacterial resistance. This review focuses on self-medication with antibiotics in Europe and its determinants. High prevalence of self-medication with antibiotics has been repeatedly found in Southern and Eastern European countries that also report high levels of an Read More

Medicinal plants are useful as a natural therapy to treat minor illnesses, as gastrointestinal disorders or as topic antiinflammatories. Also, they have been increasingly used as a coadjuvant in cronic diseases as hypertension, diabetes or hyperlipidemias. Nevertheless, many of the plants have active principles which are contraindicated or need precaution in certain illnesses as coagulation disorders or in certain states as pregna Read More

Due to a wide range of factors, such as increasing access to health information and government policies to promote self-care during the past 20-30 years, the “new patient” or ‘expert patient’ has become information strong, information seeking, increasingly demanding (or even aggressive) and skeptical of expert knowledge. This evolution in the patients’ profile has deeply changed the relationship between the patient and the he Read More