All GLG News Analyses Filed Under: Cardiology

The frequency of proton pump inhibitors (PPI) prescriptions make FDA review an important step in the long-term assessments of their risk-benefit profile.  It is important to recognize that the FDA did not change the prescribing indications or even issue a warning to physicians about the use of...

   Zyrtec (cetirizine) is a second generation nonsedating antihistamine that has enjoyed wide popularity.  Zyrtec will become available generically in late 2007 and the generic form is expected to be significantly cheaper.  To virtually extend the patent, the manufacturer is...

Levocetirizine has been approved by the FDA for treatment of allergic rhinitis and other allergic manifestations (e.g., urticaria), which means that there is yet another anti-histamine on the market with similar efficacy as already-approved anti-histamines, and yet another drug of minor (if any) marginal...

- this drug is an attempt to avoid loss of revenue when Zyrtec goes   generic in the third quarter of 2007.  - as it will be more expensive, and no more effective than generic    Zyrtec, it will likely fail

The side effect profile of zyrtec and xyzal apppear mostly similar. It is unclear what this will add to a market where generics are already in place that are nonsedating.

Adverse effects on kidney and liver. Degree of sedation. Incidence of epistaxis.

Levocertirizine is the active enantiomer of the well-known antihistamine Zyrtec. Both Zyrtic and Xyzal, undergo a rapid and complete uptake in the GI tract and then metabolized to a very limited extent and have a high renal clearance. Xyzal does not have any advantage over Zyrtec

   Cordis introduced the FIRE STAR™ Rx PTCA Dilatation Catheter to the European market.  This catheter reportedly has a lower profile than other devices on the market which enables it to cross highly stenotic or tortuous lesions.  There are no controlled studies showing device...

"The FDA announced that studies of two prescription proton-pump inhibitors, omeprazole (Prilosec) and esomeprazole (Nexium), had raised concerns about their cardiovascular safety. In the same announcement, the agency said its preliminary assessment was that the problems seen in those studies were "not...

- The FDA is under significant scrutiny and pressure following slow dissemination of new data regarding the safety of COX-2 inhibitors (ie-Vioxx) and the "-glitazones" (Avandia/Actos) - PPIs are among the most widely used medications wordwide (mostly prescribed) with tens on millions of users annually,...