To combat the growing problem of counterfeit drugs, the government is searching for ways to tighten the security of medications and to make them more tamper-proof as they travel from factories to drugstores.

The FDA is considering asking manufacturers to ship tablets in smaller quantities (e.g., 30 pills in a blister pack instead of hundreds per shipment); smaller distributors would then rebottle them. Smaller sizes can make it more difficult for counterfeiters to sneak in fakes, although this step might put an end to companies that repackage or rebottle large shipments into the smaller bottles that patients receive.

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In a study of 846 patients, adding levetiracetam (Keppra®, UCB Pharma) to antiepileptic drug therapy offered patients with difficult-to-treat, partial-onset epilepsy more than five additional seizure-free days per quarter—the equivalent of nearly three weeks a year—compared with the number of days for patients taking placebo.

In adults, partial-onset seizures are the most common manifestation of epilepsy, a condition that affects approximately 2.3 million Americans. Nearly a third of patients with partial-onset seizures have uncontrolled epilepsy that does not respond to drug therapy or other treatments. The quality of life in patients with epilepsy is directly related to the frequency of seizures, and seizure-free patients experience a health-related quality of life similar to that of the general population.
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Central nervous system adverse drug events included somnolence and fatigue, coordination difficulties, and behavioral and hematological abnormalities. Dosing must be individualized according to the patient’s renal status.

The FDA approved Keppra® tablets in 1999 for the adjunctive treatment of partial-onset seizures in adults with epilepsy. Keppra® oral solution was approved in July 2003.

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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The FDA has approved a new oral contraceptive (Seasonale®, Barr Laboratories) for women. Seasonale® contains a progestin (levonorgestrel) and an estrogen (ethinyl estradiol), which are active ingredients in traditional oral contraceptives.

Seasonale® offers a 91-day regimen. Tablets containing the active hormones are taken for 12 weeks (84 days), followed by one week (seven days) of placebo (inactive) tablets. Conventional oral contraceptive use is based on a 28-day regimen (21 days of active tablets, followed by seven days of placebo tablets).

Under the new dosing regimen, the number of expected menstrual periods usually experienced by women is reduced from once a month to about once every three months. As with the conventional 28-day regimen, women have a menstrual period while taking the placebo tablets.

Although Seasonale® users have fewer scheduled menstrual cycles, many women, especially in the first few cycles of use, had more unplanned bleeding and spotting between the expected menstrual periods than women taking a conventional 28-day cycle oral contraceptive.

Some physicians have raised concerns about the consequences of long-term suppression of menstruation, suggesting that data are insufficient to prove that suppression is safe. They also noted that the women in the studies were already taking oral contraceptives and thus would “automatically” be able to tolerate the medication; they were not compared with a control group of women who were not taking oral contraceptives. The supporters of menstrual suppression argue that ovulation itself can inflame the lining of the ovary and might be linked to ovarian cancer. The debate, no doubt, will rage on.

Because Seasonale® users can expect to have fewer periods, the label also advises women to consider the possibility that they might be pregnant if they miss any scheduled periods.

Daptomycin for injection (Cubicin®, Cubist Pharmaceuticals, Inc.) has been approved by the FDA to treat complicated infections of the skin and its structures.

Cubicin® was previously known as Cidecin®. Cubist acquired worldwide development and commercialization rights to the product from Eli Lilly & Co. in 1997.

Usually occurring in hospitalized patients, these cutaneous problems can include major abscesses, postsurgical skin wound infections, and infected ulcers. The infections are usually caused by susceptible strains of gram-positive microorganisms, such as Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dys-galactiae subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible strains only). Cubicin is not indicated for the treatment of pneumonia.

Cubicin® is the first approved product in a new class of antibiotics called cyclic lipopeptide antibacterial agents and treats infections in a way that is distinct from any other antibiotic.
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The FDA based its approval on a review of clinical studies involving more than 1,400 adults. The studies demonstrated that Cubicin® was equivalent to other standard treatments.

Most reported adverse events were mild to moderate in intensity, such as gastrointestinal disorders, injection-site reactions, fever, headache, insomnia, dizziness, and rash.

Blood tests showing muscle injury were rarely found in patients in clinical trials. Most of these patients had no symptoms, and values returned to normal after therapy.

Patients receiving Cubicin® should be monitored for the development of muscle pain or weakness, and creatine phos-phokinase levels should be assessed weekly.

The manufacturer expects the medication to be available by early November 2003.

Generic Valacyclovir HCl (Valtrex® Caplets, GlaxoSmithKline) has been approved to reduce the risk of heterosexual transmission of genital herpes to susceptible partners with healthy immune systems when used as suppressive therapy in combination with safer sex practices. The drug was first approved for the treatment of genital herpes in 1995.

Many individuals have no or only minimal signs or symptoms and may transmit the virus during sexual contact when they show no signs of active infection, such as genital lesions.

The FDA revised the labeling for Canadian Valtrex® on the basis of an international, double-blind, placebo-controlled eight-month clinical trial involving approximately 1,500 monogamous, heterosexual couples. At the beginning of the study, only one member in each couple had evidence of genital herpes. The results showed a 48% reduction in herpes simplex virus acquisition, although individual results may have varied on the basis of safer sex practices.

The medication has caused kidney and nervous system problems (e.g., aggressive behavior, unsteady or shaky movements, confusion, speech problems, hallucinations, seizures, and coma) in some patients with pre-existing renal disease and in elderly patients with impaired renal function. Patients should inform their health care providers if they have had kidney problems or other medical conditions before taking Valtrex®.

Some atypical antipsychotic drugs, especially olanzapine (Zyprexa medication, Eli Lilly) and clozapine (Clozaril®, Novartis), may induce glucoregulatory dysfunction that can lead to diabetes. Researchers who analyzed data on 5,837 patients in the Veterans Affairs database found that olanzapine therapy was associated with a 37% higher risk of diabetes compared with risperidone treatment.

Of 5,837 patients, 368 (6.3%) had a marker for diabetes, on average within 15 months. Only generic olanzapine was associated with the increased risk, which was consistent across all analyses, including those that controlled for factors such as other drugs, race, age, and substance abuse.

The researchers note that their num­bers might be low, because the markers they used (i.e., the International Classification of Disease ICD-9-CM diagnosis codes and prescriptions for hypo-glycemic drugs) tend to underestimate the prevalence of new-onset diabetes.