Expert opinion on drug safety
-
Migraine affects about 25% of women during childbearing years but few data are available about the risks connected with most antimigraine drugs during pregnancy. ⋯ Migraine treatment is often necessary because maternal and fetal risks related to acute attacks may be more harmful than the therapy itself, especially if they are frequent, severe and associated with nausea, anorexia, vomiting, hypotension or dehydration. If non-pharmacologic treatments do not alleviate migraine symptoms, only few drugs can be used during pregnancy and lactation.
-
Expert Opin Drug Saf · Nov 2012
Comparative StudySafety and efficacy evaluation of ambrisentan in pulmonary hypertension.
Pulmonary arterial hypertension (PAH) is characterized by an increase in pulmonary vascular resistance, which can lead to right heart failure and death. Endothelin-1 binding ETA and ETB receptors seem to play a critical role in the pathogenesis and progression of the disease, and oral endothelin receptor antagonists (ERAs) have been shown to be an effective treatment. Bosentan and ETA-selective ambrisentan are the ERAs currently available for PAH treatment. ⋯ Ambrisentan has shown an efficacy comparable with other ERAs. Compared with bosentan, ambrisentan seems to have a better safety profile with regards to hepatic safety and drug-drug interactions. On the other hand, ambrisentan shows a higher rate of other adverse events, such as nasal congestion and peripheral edema. Ambrisentan is a viable option for PAH treatment. However, there is still a need for more robust data about long-term mortality, treatment in non-PAH pulmonary hypertension (PH) (such as PH due to left heart disease and PH due to chronic hypoxic lung diseases) and combination therapy.
-
Expert Opin Drug Saf · Apr 2015
Pixantrone: a novel anthracycline-like drug for the treatment of non-Hodgkin lymphoma.
The current treatment approach of high-grade non-Hodgkin lymphoma (NHL) relies to a large extent on anthracycline-based regimens yielding cure rates in ∼ 65 - 75% of patients. Despite being highly effective, these regimens are associated with significant long-term toxicity with a cumulative 10-year incidence of cardiovascular disease of 22%. Moreover, for the 25 - 35% of patients who fail first-line therapy there has been very little progress in terms of salvage regimens over the past 15 years. Re-treatment with anthracyclines-based regimens was, until now, not an option given the extensive cardiac toxicity of these agents. Pixantrone dimaleate (Pixantrone) is a novel anthracycline-like drug that offers an interesting alternative for the treatment of aggressive NHL. ⋯ Pixantrone is a potential alternative agent with a favorable safety profile for the treatment of relapsed and refractory NHL patients. It might benefit from combinations strategies and further development in the elderly and frail population.
-
Expert Opin Drug Saf · Jul 2005
EditorialCounterfeit drugs: defining the problem and finding solutions.
The problem of counterfeit drugs is increasingly becoming a top priority of drug regulatory agencies, licit pharmaceutical manufacturers and healthcare professionals, and is of rising concern among consumers. A review of the current literature reveals that counterfeiting is no longer isolated in developing nations, but is a worldwide pandemic. Although international organisations such as the World Health Organization, have devised specific measures to combat the counterfeit trade, the problem still remains quite daunting. Although the practice of drug counterfeiting is unlikely to ever completely disappear, it may be controlled if governments and all relevant parties combine forces to identify and disrupt the counterfeit chain.