FDA actions

The FDA has updated labeling of the new tamper-proof oxycodone (OxyContin), while at the same time denying approval of generic forms of the original formulation of oxycodone. The new labeling indicates that the product "has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting)." The agency's refusal to approve generic forms of the original formulation was based on the increased risk of abuse inherent in the non-tamper proof form leading to the risk of serious adverse events including overdose and death. Because of this, the agency has determined that the benefits of the original OxyContin and its generics no longer outweigh its risks and it has been withdrawn from sales. The new tamper-proof formulation is more difficult to crush, break, or dissolve. If tampered with, it forms a viscous hydrogel that cannot be easily injected or snorted. Oral abuse is still possible.

The FDA has approved a fixed combination of doxylamine succinate and pyridoxine for the treatment of nausea and vomiting due to pregnancy. This is a reintroduction of a product widely used between 1956 and 1983. Then marketed as Bendectin, the product was voluntarily withdrawn by the manufacturer due to lawsuits related to birth defects, although evidence of risk was not supported by scientific evidence. The reapproval was based on a study of 261 women experiencing nausea and vomiting due to pregnancy in which the drug was more effective than placebo in relieving symptoms. Since the 1980s, observational studies have shown that doxylamine and pyridoxine do not pose an increased risk of harm to the fetus. The recommended starting dose is two tablets taken at bedtime on an empty stomach. The combination is marketed by Duchesnay Inc. as Diclegis.

The FDA has approved prothrombin complex concentrate for the rapid reversal of anticoagulation by warfarin and other vitamin K antagonists. Plasma is the only other option for this use currently available, and prothrombin complex can be given at significantly lower volume than plasma. The product is made from pooled plasma of healthy donors that is processed to minimize the risk of viral and other diseases. The approval was based on a study of 216 patients who were anticoagulated and had major bleeding. Plasma complex concentrate was found to be similar to plasma in its ability to stop major bleeding. Plasma complex concentrate is marketed by CSL Behring as Kcentra.