Alimera Sciences has announced the arrival of Soothe™ Emollient (lubricant) Eye Drops, the market’s first multidose, emollient-based artificial tear product. The drops offer over-the-counter relief to the 12 million Americans with dry eye, a painful condition in which the body cannot produce enough tears to keep the eye surface lubricated.

Soothe™ features a lipid restorative (Restoryl™) that re-establishes the eye’s protective oily layer to reduce tear evaporation and to seal in essential moisture, giving patients up to eight hours of comfort.
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Approximately 15% of the population 65 years and older have dry eye, and it is especially prevalent in women. Certain medications, contact lenses, the environment, and indoor air conditioning or heating can also affect moisture levels in the eye.

The FDA has approved ziprasidone medication (Canadian Geodon®, Pfizer) to treat acute bipolar mania. Nearly 4% of Americans have bipolar disorder, a condition that causes severe mood swings. Rapid control of acute mania is important, because patients are at increased risk for dangerous and impulsive acts, including aggressive and suicidal behavior.

This product causes little or no weight gain and is associated with fewer adverse changes in certain metabolic indices, such as lipid levels and glucose control, than other agents in its class. Significant improvements were typically seen within two days after treatment began.

According to a survey conducted by Harris Interactive® of 554 patients with bipolar disorder in the U.S. over the age of 30, most patients gained an average of 50 pounds while taking other bipolar drugs; 10% gained 100 pounds or more with other drugs.

Geodon® was approved for the treatment of schizophrenia in the U.S. in February 2001 and received approval for treating acute bipolar mania in August 2004.

High blood glucose levels and intra-cranial hemorrhage are independent predictors of sudden worsening in patients with acute ischemic stroke who are receiving thrombolytic therapy, say researchers from University Hospitals of Cleveland and Case Western Reserve University.

In their study of 201 patients who received the therapy, 13% of the patients worsened, 39% improved, and the rest remained unchanged 24 hours after treatment was begun. The in-hospital mortality rate was 16%. No patients whose Stroke Scale score decreased died, compared with 73% of those whose scores increased.
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Patients who deteriorated were more likely to have hyperglycemia (above 150 mg/dl), even in the presence of recanalization. The findings support earlier research that hyperglycemia worsens the outcome for stroke patients.

Women can use aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) for years without suffering renal function problems, according to data from the Nurses’ Health Study. Acetaminophen is another story, but not a markedly worse one.

Researchers from Brigham and Women’s Hospital and Harvard University studied information from 1,697 women who responded to a questionnaire in 1999. The women’s blood samples, which were collected in 1989 and 2000, were also evaluated. The main outcome was change in estimated glomerular filtration rate over 11 years.
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The researchers observed no association between lifetime use of aspirin or NSAIDs and the risk of decline in renal function, even among women who had consumed 3,000 g or more of the drug. In contrast, women who had consumed 100 g or more of acetaminophen over their lifetimes seemed to be at greater risk of losing “an important proportion” of their renal function, compared with those who had taken less than 100 g. Even so, most women who had consumed 3,000 g or more of acetaminophen did not have significant renal dysfunction, and the magnitude of the association depended on the formula used to estimate renal function. There was no apparent interaction between acetaminophen and aspirin.

The use of estrogen does not reduce the risk of dementia in older women and might even increase it. A trial suggests that hormone replacement therapy (HRT) might increase health risks in postmenopausal women. The study’s authors, from Wake Forest University School of Medicine in Winston-Salem, North Carolina, recommend against using HRT to prevent dementia in women aged 65 or older.

Previous research had shown that women using an estrogen-progestin combination were also at an increased risk for dementia or age-related functional impairment, including Alzheimer’s disease, and that HRT had no effect on mild cognitive impairment or memory loss. That research, part of the Women’s Health Initiative (WHI), was halted two years ago amid indications that HRT did more harm than good.
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In February 2004, the National Institutes of Health halted another study involving estrogen-only therapy because the risk of stroke was considered to outweigh the benefit of possible protection against coronary heart disease.

Wyeth, the maker of hormone therapies, said that doctors should consider the data as they assess patients’ needs and emphasized that the data might not apply to newly postmenopausal women.

The FDA has approved two injectable drugs, pentetate calcium trisodium (Ca-DTPA) and pentetate zinc trisodium (Zn-DTPA), for treating internal radiation contamination from plutonium, americium, or curium. The new drugs increase the rate of elimination of these radioactive materials from the body.

Ca-DTPA and Zn-DTPA have been used for several decades as investiga-tional agents in contamination emergencies. In September 2003, the Food and Drug Administration (FDA) announced specific conditions under which these drugs could be approved through new drug applications.

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The U.S. Food and Drug Administration (FDA) has approved trospium chloride tablets (Sanctura™, Pliva) for the treatment of overactive bladder. Symptoms include urge urinary incontinence, urgency, and urinary frequency.

As a quaternary ammonium compound, this agent belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder. Sanctura™ is currently marketed as a prescription drug in Europe. canadian discount drugs

Patients with urinary or gastric retention, uncontrolled narrow-angle glaucoma, or hypersensitivity to the product should not use it.

Sanctura™ is scheduled to be available for sale in the U.S. in late 2004.