Drug Formulary Review 2005-05-01

COX-2s and NSAIDs must add warnings, patient guides to package inserts

Manufacturers of prescription cyclooxygenase-2 (COX-2) selective and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) soon will have stronger warnings on their labels.

FDA drug approvals jump in 2004

Journal Review: Aspirin effective as warfarin in treating intracranial stenosis

Researchers in a new clinical trial say it shows for the first time that aspirin works as well as warfarin (Coumadin) in treating intracranial stenosis but with fewer side effects.

News Briefs: Bevacizumab/chemotherapy show benefits for advanced lung cancer

Preliminary results from a large, randomized clinical trial for patients with previously untreated advanced nonsquamous, non-small cell lung cancer show that those patients who received bevacizumab (Avastin) in combination with standard chemotherapy lived longer than patients who received the same chemotherapy without bevacizumab.

News Briefs: FDA issues nationwide alert on one lot of intravenous solution

The FDA has issued a nationwide alert against the use of PharMEDium Services Magnesium Sulfate 1 g in 50 mL D5W (piggyback) IV solution, lot number 100504900049, and expiration date 4/4/05. This product is manufactured by PharMEDium Services of Houston and may be contaminated with Serratia marcescens bacteria that can cause serious, life-threatening illness in patients with compromised immune systems.

News Briefs: FDA revises interferon beta-1a, drotrecogin alfa (activated) labels

The FDA and Biogen have notified health care professionals of revisions to the warnings, precautions/drug interactions, and adverse reactions/post-marketing experience sections and medication guide of interferon beta-1a (Avonex). Severe hepatic injury, including cases of hepatic failure, has been reported in patients taking interferon beta-1a.

News Briefs: Arthritis patients remain confused about pain meds’ safety

Many arthritis patients are suffering because they have stopped or reduced their use of pain relievers due to confusion about which drugs are considered safe, says a survey conducted by the Rippe Lifestyle Institute (RLI) in Boston. Among this group, 68% reported a resulting decrease in their overall quality of life due to greater pain and limited physical activity.

New FDA Approvals

These drugs were recently approved by the FDA:

In the Pipeline

PharmaMar announces that its second most advanced marine-derived antitumor agent, Aplidin, has commenced Phase II clinical trials in both prostate and bladder cancers.

Drug Criteria & Outcomes: Eszopiclone (Lunesta) Formulary Evaluation

Eszopiclone (Lunesta) is the first member of a new drug class known as a pyrrolopyrazine derivative of the cyclopyrrolone class. It is a nonbenzodiazepine hypnotic agent with a chemical structure unrelated to any other drugs with known hypnotic properties.

Drug Formulary Review Archives – May 1, 2005

May 1, 2005