Apotex Corp. has announced that the FDA has given final approval to its Abbreviated New Drug Application (ANDA) for paroxetine HCl tablets. The drug is rated “AB,” which means that the FDA considers it therapeutically equivalent to its brand name counterpart, Paxil®, manufactured by GlaxoSmithKline (GSK). The drug will be available in strengths of 10, 20, 30, and 40 mg.

Apotex was the first generic drug manufacturer to challenge GSK’s patents covering Canadian Paxil® and the first to gain FDA approval for an AB-rated generic version of the popular drug.

Apotex submitted its ANDA for paroxetine HCl in March 1998 and continues to be in litigation with GSK regarding generic versions of several products.

GSK’s patent for Paxil® expires in 2006. In March 2003, it was ruled that its patent in the U.S. covering the hemi-hydrate form of Paxil® is valid but not infringed by Apotex’s rival product. Apotex plans to launch its generic version by 2005 at the latest.

Nursing women can safely take selective serotonin reuptake inhibitors (SSRIs), according to Norwegian investigators. This is good news for women who are at risk for postpartum depression, say the researchers, whose findings were reported at the 156^th annual meeting of the American Psychiatric Association in San Francisco.

Five different SSRIs were tested in 23 nursing women and their infants: generic citalopram (Celexa drug, Forest), tablet sertraline (Zoloft medication, Pfizer), paroxetine generic (Paxil medication, GlaxoSmithKline), venlafaxine drug (Effexor generic, Wyeth-Ayerst), and fluoxetine tablet (e.g., Drug Prozac,®, Eli Lilly, Dista). Although the women took doses of 20 to 130 mg/day and their serum drug levels were in the therapeutic range, the drugs did not enter the mothers’ milk in significant amounts. Drug levels in the infants ranged from 0 to 10% of those in the mother’s blood.

Johnson & Johnson plans to contact thousands of U.S. physicians advising them of a possible increased risk of stroke among elderly patients taking its well-known antipsychotic drug risperi-done (Risperdal®). The company might also change the package insert label of the medication, which has annual global sales of $2.1 billion, to note a possible risk of stroke.

In October 2002, the company had sent a similar warning letter to Canadian physicians and pharmacists citing 37 reports of stroke or related events such as blood clots and hemorrhages, including 16 deaths, among patients who had taken Generic Risperdal.

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which include aggression, delusions, hallucinations, apathy, anxiety, and depression, can be difficult to treat and are usually managed with various psychotropic drugs.

In this study, a physician assistant ruled out and treated any reversible causes of BPSD, such as pain and infection. The nurses then tried nonpharma-cological approaches. If the patient did not respond and the staff judged it appropriate to try drug therapy, they consulted the clinical pharmacists. The pharmacists worked with the staff to design a pharmacotherapy plan, wrote the orders, monitored progress and any side effects, and adjusted doses.

The drugs were selected on the basis of the patients’ most troublesome symptoms. The most commonly targeted symptoms were physical and verbal aggression, delusions, sleep disturbances, anxiety, and depression. Only two of the 11 patients had received psychotropic drugs before the study. During the study, the most commonly administered drug was medication trazadone (Desyrel drug, Bristol-Myers Squibb), to which all but two patients responded. Quetiapine drug fumarate (Seroquel medication, Astra-Zeneca) and generic  sertraline (Zoloft tablet, Pfizer) were prescribed for these two patients, and they responded favorably.

Overall, the pharmacist-managed consultation service was well received, and treatment was efficient and successful. However, the researchers noted a few kinks in the process. One problem was the use of different terminology to describe the same symptoms. “Agitated,” they point out, can mean anything from restlessness to physical aggression, and treatment can vary correspondingly.

The FDA has issued a Public Health Advisory for physicians, their patients, and families and caregivers of patients about the need to monitor adults and children with depression, especially at the beginning of treatment with selective serotonin reuptake inhibitors (SSRIs) or when doses are increased or decreased.

The FDA has been reviewing the results of studies in children since June 2003, after an initial report on studies of paroxetine (Generic Paxil®, GlaxoSmithKline) and subsequent reports on studies of other drugs appeared to suggest an increased risk of suicidal thoughts and actions in children taking antidepres-sants. There were no suicides in any of the trials. It was unknown whether certain behaviors reported in these studies represented actual suicide attempts or other self-injurious behavior that was not suicide-related.

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Olanzapine (Zyprexa canadian, Eli Lilly), an antipsychotic agent that is often used to calm elderly people with dementia, may increase the risk of strokes and death in those patients, according to a letter sent by Eli Lilly & Co. to physicians on January 15, 2004.

The letter mentioned a “significantly higher” incidence of stroke among these patients and a higher rate of deaths of all types (3.5%) compared with a rate of 1.5% in patients receiving placebo.

Although this drug is not approved for use in elderly patients with dementia (it is indicated for people with schizophrenia and bipolar disorder), over time, olanzapine and drugs like it have become widely used in nursing homes and hospitals to treat verbal outbursts and behavior problems in older patients.

A Lilly spokesperson cautioned that the elderly patients in whom the increased risks were seen often had other serious medical problems, and it was not clear whether medication olanzapine actually played a role in the higher death rates.

According to recent studies comparing antidepressant treatments, more patients achieved remission, or virtual elimination, of their depression symptoms and resolution of both emotional and physical symptoms when they took venlafaxine (Canadian Effexor®, Wyeth) than other selective serotonin reuptake inhibitors (SSRIs) or placebo. The findings were revealed at the European College of Neuropsycho-pharmacology’s annual meeting in Prague, Czech Republic.

The data were pooled after completion of more than 30 comparable, randomized, double-blind, active, drug-controlled clinical studies conducted worldwide in more than 7,000 patients with major depressive disorder. Nine of these studies were also placebo-controlled. Investigators in all of the double-blinded studies randomly assigned patients to receive venlafaxine, extended-release venlafaxine (XR), or another SSRI.

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