A New Test, New Drugs and New Options

Today's Pharm Report looks at a new bladder drug, a promising vaccine for ear infection, a new test to improve the accuracy of prostate cancer detection, another choice for postmenopausal women, a generic form of the anti-psychotic drug clozapine, and an increase in research on children's medication.


Treating Overactive Bladder: The first new medication in more than 20 years has been approved for the treatment of overactive bladder. The Food and Drug Administration granted Pharmacia & Upjohn the go-ahead to market Detrol, a tablet that may help the estimated 17 million Americans with bladder-control problems.

Overactive bladder is marked by symptoms of urinary urgency and frequency (urinating more than eight times in 24 hours). The problem affects people of all ages, and the medication is thought to work well for all age groups. In studies, Detrol reduced the median number of times people urinated in a 24-hour period. Possible side effects include dry mouth, headache, constipation and indigestion.

Detrol, which must be obtained with a prescription, should be available in all pharmacies soon.


Option to Estrogen Therapy: Postmenopausal women who are struggling with the decision of whether to take estrogen therapy now have another alternative. The lowest effective dose of estrogen--about half the usual dose--has been approved by the FDA for prevention of osteoporosis.

The medication, called Estratab, which comes in a 0.3-milligram estrogen tablet, was found in studies to help women preserve or slightly increase their bone mineral density in the spine, hip and whole body. Women on this low dose may also experience fewer of the side effects typical of estrogen therapy, such as headache, nausea, breast tenderness and bleeding.

In addition to helping protect against bone loss, Estratab provides some relief for hot flashes and night sweats. Moreover, the women using Estratab did not experience an increase in endometrial hyperplasia, a precursor of endometrial cancer--which is a drawback of traditional estrogen therapy.


Prostate Cancer Test: A new blood test to improve the accuracy of prostate cancer detection is now available.

The FDA approved the new blood test, Hybritech Free PSA, for marketing by Beckman Coulter of Fullerton. It is expected to reduce the number of unnecessary prostate biopsies by 20%. The test should help doctors to differentiate between prostate cancer and benign prostate conditions. Studies show Hybritech Free PSA detects the disease accurately in 95% of cases.

High PSA (prostate specific antigen) can indicate prostate cancer, but levels can also rise due to non-cancerous conditions. The new test will be used as a follow-up test to an initial PSA test when moderate or high levels of the antigen are detected. Thus, the availability of the Hybritech should resolve some of the controversy about liberal use of the PSA test.


Clozapine Generic on the Market: A generic form of the anti-psychotic drug clozapine is now available. The new medication is made by Zenith Goldline Pharmaceuticals. It will be about 15% less expensive than the brand-name Clozaril but will still require the weekly blood that is required of Clozaril use.

According to the Central San Fernando Valley Alliance for the Mentally Ill, Medi-Cal, so far, has not demanded that patients on Clozaril switch to the generic version. Patients should consult with their physicians before switching. To avoid a switch occurring without their knowledge, patients or caregivers should check the label for the phrase "generic for Clozaril" or "clozapine-Zenith Goldline."


Hope for Ear Infections: An experimental vaccine for childhood ear infections is a step closer to reality. A study in the April issue of the journal Pediatrics showed that the vaccine against pneumococcal disease is safe and effective. Pneumococcal disease is a group of illnesses, such as ear infection, pneumonia, bacteremia and bacterial meningitis, caused by a bacteria Streptococcus pneumoniae. The illnesses are usually treated with antibiotics. But there is an alarming trend in cases showing antibiotic-resistant strains of the bug.

Two major studies to look at the effectiveness of the vaccine in preventing ear infection are underway--one in Northern California. However, the vaccine is still probably a few years away from FDA approval.


Medicines for Children: The pneumococcal vaccine is among 23 vaccines that are now being studied for use in children, according to the Pharmaceutical Research and Manufacturers of America. Overall, the association said in a recent report, 187 drugs and vaccines for children are under development--a 28% increase in the past year alone.

The increase represents a new effort by drug makers to test medications specifically for safety and effectiveness in children--despite the potential for practical, legal and ethical dilemmas inherent in such research.

In addition to vaccines, 44 cancer drugs are in development. AIDS, asthma, cystic fibrosis, infectious diseases and respiratory diseases have also been targeted as priorities among manufacturers.

Among the promising research is a nasal spray vaccine against flu, three new medications for juvenile rheumatoid arthritis, a gene therapy for brain tumors and a medicine to treat psychotic disorders in children as young as 5 years of age.

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