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.

Since their introduction in the 1980s, quinolones have been associated with tendon disorders. So it isn’t farfetched to speculate that the rising number of case reports of Achilles’ tendon ruptures and other similar problems might be linked to the increased use of quinolones. That’s the basis of a study analyzing 1,367 cases reported in the United Kingdom between 1988 and 1998.

The researchers defined cases as those in which the patient had a first-time recorded Achilles’ tendon rupture and who had at least 18 months of a valid history of rupture before the index date. The control group included a random sample of 50,000 patients.

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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.

In response to the availability of one nonsedating antihistamine as an over-the-counter drug, state Medicaid and several large health insurers are considering whether to end prescription drug coverage for all nonsedating antihista-mines. These policies, by their design, would diminish access to recognized standards of treatment for millions of patients with allergic diseases. Professional experience suggests that these actions not only would lower the quality of medial care for affected patients but also would have significant health and safety implications for the general public.

Allergic diseases occur in 10% to 25% of the population, and up to 40% of those affected are children.
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To varying degrees, antihistamines have the capacity to compete with hista-mine for type H1 receptors and to reduce receptor-mediated activation, thus blocking histamine’s adverse effects. Although all of the members of this class of medications are referred to as “antihistamines,” they vary in their pharmacology. Therefore, the selection of any one of these agents should be made in consultation with an experienced health care practitioner, especially for the majority of patients with persistent disease.

One of the concerns created by these policies is the danger associated with self-medication.

Policies that limit patients’ access to appropriate medications impede a physician’s ability to prescribe the best treatment regimens and should not be mistakenly viewed as being endorsed by trained health care professionals.

The complex of symptoms and disorders called Gulf War veterans’ illnesses has been a major medical puzzle for years. One hypothesis is that the complex is caused by an underlying systemic infection with Mycoplasma species, specifically M. fermentans, and that long-term treatment with generic doxycycline might work.

The U.S. Departments of Veterans Affairs and Defense conducted a randomized, placebo-controlled study of 491 veterans, all of whom had detectable Mycoplasma DNA in their blood. After 12 months of treatment and six months of follow-up, the veterans were, for the most part, no better off. In fact, long-term doxycycline therapy not only did not help but might have even harmed them.

Doxycycline might have had a limited effect because there was no underlying infection, or the veterans’ illnesses might have been a consequence of previous infections, the researchers say. Some of the patients who improved at three months might have had another infection that doxycycline did help, or the drug might have had an anti-inflammatory effect.

Adherence to treatment declined after six months, dropping to roughly two thirds of both groups at 12 months. The researchers could not say whether better adherence would have led to more improvement.

Researchers have observed a drug-drug interaction between repaglinide (Prandin generic, Novo Nordisk), a short-acting insulin secretagogue, and gemfibrozil (Drug Lopid®, Pfizer) a lipid-lowering agent used to treat dyslipidemia.

Co-administration of gemfibrozil with repaglinide in healthy volunteers resulted in significant elevations of repaglinide levels, and co-administration of itraconazole (Sporanox®, Janssen), an antifungal agent, with medication gemfibrozil and repag-linide further increased such effects. Changes in the pharmacokinetics of repaglinide were attributed to inhibition of the cytochrome P-450 enzyme system by gemfibrozil and itraconazole. Alterations in blood glucose levels were also affected by these concomitant medications, with enhanced and prolonged pharmacodynamic effects of repaglinide canadian.

Although the study involved healthy volunteers, Novo Nordisk considers these results to be important, because an increased risk of hypoglycemia cannot be ruled out for patients with type-2 (non-insulin-dependent) diabetes. According to what is now known about the metabolism of other lipid-lowering fibrate derivates, a similar interaction between repaglinide and other agents within the class is not expected.

The European Agency for the Evaluation of Medicinal Products (EMEA) has issued a public statement and has pointed out the following information to physicians:

1.  Because of the documented interaction and risk of hypo-glycemia, the concomitant use of the two agents is contra-indicated.

2.  For patients already receiving the two drugs, an alternative combinaton treatment should be considered along with close monitoring of diabetic status.

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.