Few new antibiotics are in the pipeline

Despite a critical need for new antibiotics to treat drug-resistant infections and other infectious diseases, very few new antibiotics are being developed, according to a study published in the May 1 issue of Clinical Infectious Diseases.

To document trends, researchers evaluated U.S. Food and Drug Administration (FDA) databases of approved drugs and the research and development (R&D) programs of the world’s largest pharmaceutical and biotechnology companies, by looking at the companies’ web sites and 2002 annual reports. They found that the FDA approvals of new antibiotics declined 56% during the past 20 years (1998-2002 vs. 1983-1987). Looking to the future, the researchers found only six new antibiotics in the R&D pipeline out of 506 drugs being developed. The FDA recently approved one of those drugs, telithromycin.

Bacteria, which are treated with antibiotics, are by far the most common cause of infection-related deaths in the United States. Because of the emergence of drug-resistant bacteria, the researchers note that there are few or no treatment options for many infections.

Although the need for new antibiotics is increasing, a number of factors make these drugs less economically attractive than drugs that treat chronic diseases. For instance, antibiotics usually are prescribed for one or two weeks at most while some drugs are taken for life. In addition, the researchers note that in order to prevent the evolution of resistant strains of bacteria, infectious disease physicians try very hard to limit the overuse of newer antibiotics. One of the researchers, however, believes that the lack of new antibiotics in development is caused by a complicated "systems problem," and not by irresponsibility on the part of the pharmaceutical companies, the FDA, or physicians.

Pharmacy groups establish compounding accreditation board

A coalition of pharmacy-related professional and regulatory organizations has announced the creation of a voluntary accreditation program for pharmacy compounding.

The Pharmacy Compounding Accreditation Board was established to help improve the quality and raise awareness of compounding. The governing board is expected to consist of the following organizations: the American College of Apothecaries, the American Pharmacists Association, the International Academy of Compounding Pharmacists, the National Association of Boards of Pharmacy, the National Community Pharmacists Association, the National Council of State Pharmacy Association Executives, the National Home Infusion Association, and the United States Pharmacopeia. Stakeholder organizations invited to provide input include the American Association of Colleges of Pharmacy, the American Society of Consultant Pharmacists, the American Society of Health-System Pharmacists, and the National Association of Chain Drug Stores.

The program should be developed within the following months with the first pharmacy site accredited by the end of the year.

Be aware of possible drug mix-ups for obstetrical patients

Pharmacists are being warned again of possible dangerous mix-ups between the pharmacological opposites methylergonovine maleate (Methergine) and terbutaline sulfate (Brethine).

Numerous reports of injuries have been related to lookalike packaging of these products, and two alerts have been previously published warning health care providers about the risk of mix-ups. Both agents frequently are stored and used in labor and delivery settings, but for different clinical reasons. Terbutaline is used to treat pre-term labor, and methylergonovine primarily is used after delivery of the placenta to treat uterine atony, subinvolution, or hemorrhage. Since methylergonovine has abortifacient properties, it is contraindicated in pregnancy and would be especially dangerous to a patient in pre-term labor. Both of these products are packaged as 1 mL ampules within an amber plastic tub covered by a foil label with the product name in tiny print, making them difficult to tell apart. Both ampules also have similar colored "rings" around the ampule necks that can be seen through the amber plastic, which further adds to their similarity. With so many risk factors, these medications are prone to being interchanged.

Interchanging these two drugs could result in serious adverse outcomes for the mother and baby. In one reported case, four doses of methylergonovine were administered to a patient in pre-term labor, which was believed to contribute to fetal demise. In another recently reported case, a 35-year-old female was experiencing significant preterm uterine contractions. Her physician diagnosed fetal distress and asked a nurse to administer terbutaline IV push. Instead, the nurse accidentally administered Methergine. The mother experienced significant contractions requiring an emergency cesarean. Fortunately, the patient and newborn were discharged two days later unharmed.

Pancreatic extract makers to submit marketing applications

The U.S. Food and Drug Administration (FDA) has notified manufacturers of pancreatic insufficiency products that these drugs must get approval by the agency within the next four years to remain on the market. The FDA decided to require approval of new drug applications for all pancreatic extract drug products after reviewing data that showed substantial variations among currently marketed products.

Specifically, the FDA review found that variations in the formulation, dosage, and manufacturing processes affected the potency — in terms of both the products’ activity and release rate — of the enzymes after patients take them. The resulting variations in drug potency could significantly affect the safety and effectiveness of the drugs.

The FDA does not expect prices to change as a result of this notice. The FDA’s economic analysis of this action found that although some firms may choose to discontinue marketing, enough manufacturers would continue producing pancreatic enzyme products to keep the market competitive.

Concurrent oxandrolone, warfarin use may have adverse effect

Savient Pharmaceuticals is updating health care professionals about the use of its product oxandrolone (Oxandrin) when used in patients concurrently treated with the oral anticoagulant warfarin for systemic anticoagulation.

Oxandrin, a synthetic derivative of testosterone, is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma; in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, or to offset the protein catabolism associated with prolonged administration of corticosteroids; and for the relief of the bone pain frequently accompanying osteoporosis.

A recent clinical study conducted by Savient demonstrated a significant decrease (80%-85%) in the warfarin dose needed to achieve therapeutic effect in subjects also treated with oxandrolone. The study results were significant, and the U.S. Food and Drug Administration approved a change to the oxandrolone labeling as a result. The recommendations are specific to oxandrolone and cannot be presumed to be applicable for other anabolic androgenic steroids.

For complete label information, see www.fda. gov/medwatch/SAFETY/2004/safety04.htm# oxandrin.