Remove 2016 Remove Safety Remove Side effects
article thumbnail

How can evidence-based medicine (EBM) methodology support drug withdrawals?

European Pharmaceutical Review

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Supporting regulators. It focused on data from France, Germany and the UK.

article thumbnail

Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. Our research showed that in Europe between 1999 and 2016, 35 products were withdrawn. But over time, trends in what evidence is most available and therefore most used, change.

Medicine 116
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. Irinotecan – also known by the brand name Campto/Camptosar ® (Pfizer Ltd.) – has proven to be an effective chemotherapy agent against several types of gastrointestinal cancer. 5): V38-V49.

Patients 104
article thumbnail

Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. 2016; 46: 479–93. Adverse events were relatively low in both groups (2.22

Safety 111
article thumbnail

How Pharmacogenomics may finally realise its promise

pharmaphorum

In 2016, the estimated annual cost of drug-related morbidity and mortality resulting from non-optimised medication therapy was $528.4 This means that hyper-metabolisers would need their dosage to be increased to achieve the desired effect. billion in the United States alone.

article thumbnail

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Medgadget

These treatments at times come with a long list of side effects, leaving many patients in search of an effective long-term solution. For some patients with PTSD, psychotherapy may not be an effective option, they may find talking about their traumatic experience stress inducing, untherapeutic or ineffective.

article thumbnail

Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

While new positive clinical data with anti-Abeta mAbs signal tremendous advancement and proof‑of-concept for the whole field, it is believed that the observed effects could still be improved and optimised in terms of greater clinical benefits, lower side effects and enhanced treatment convenience.