New Drugs 2008-2009- Pharmacist
In 2008, the FDA approved 21 new molecular entities (NMEs) and 7 significant new biologicals, compared with 17 NMEs and 2 biologic products in 2007. Despite the increase in approvals, there are no apparent blockbuster drugs. While the pharmaceutical industry suggests that “newly approved” means “new and improved,” this is often far from the truth. Many recently approved drugs are not innovations, but rather “me-too” products. In addition to misleading marketing, the true value of new drugs is often obscured by the incomplete and potentially biased state of the published literature. Incomplete post-marketing studies that are requested by the FDA at the time of approval also cloud the real benefits or disadvantages of new drugs. With all these influences, it is essential that providers use a critical eye when sifting through the available information, in order to better educate patients and colleagues. New is not always better.
This issue reviews 8 new drugs or novel new formulations that you are most likely to encounter in clinical practice including alvimopan (Entereg®), certolizumab (Cimzia®), desvenlafaxine (Pristiq®), fenofibric acid (TriLipix®), fesoerodine (Toviaz®), methylnaltrexone (Relistor®), milnacipran (Savella®), and silodosin (Rapaflo®). The reviews consist of the indication, the drug’s role in therapy, usual dose, precautions, drug interactions, and practical patient counseling points. Handy tables encompass brief overviews for 11 additional new drugs, new formulations you are likely to see in practice, and new combination products.