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The Food and Drug Administration (FDA) announced in early August that Bayer Pharmaceutical Division was voluntarily withdrawing cerivastatin (Baycol) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe adverse reaction of the muscles from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision.
Fatal rhabdomyolysis reports with Baycol, which initially was approved in the United States in 1997, have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid-lowering drug. FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use.
Bayer Pharmaceutical Division has announced plans to recall Baycol to the pharmacy level. Pharmacies should return the product to the manufacturer for a refund.
A new vaccine blocked the development of Alzheimer’s disease in mice genetically engineered to carry the human gene for the degenerative brain disease, researchers say
Researchers at New York University School of Medicine expect to test the vaccine, which is based on a modified, nontoxic peptide, in initial human clinical trials within a year. They express optimism that this vaccine will prove to be safer than another vaccine already in human clinical trials.
The researchers injected the new vaccine into 11-month-old mice that had been genetically engineered with a human gene for Alzheimer’s disease. At that age, the mice already had formed amyloid plaques in the brain, which is characteristic of the disease. Seven months later, the researchers examined the brains of the mice.
They found that the amount of amyloid plaque was reduced by 89% in the cortex, the center of higher thought, and by 81% in the hippocampus, the memory center, compared to the brains of mice that also had been genetically engineered but were not given the vaccine. The vaccinated mice also had 57% less of the protein that fosters the development of amyloid plaque.
The study appears in the August 2001 issue of the American Journal of Pathology.
The Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration (FDA) voted in late July not to recommend approval at this time of Amylin Pharmaceuticals’ pramlintide acetate (Symlin) for the treatment of Type 1 and insulin-using Type 2 diabetes. However, eight out of nine committee members voted that the data presented were adequate to demonstrate efficacy of Symlin in both Type 1 and insulin-using Type 2 diabetes, which the FDA also acknowledged in their presentation. The majority of the committee members voiced encouragement for the potential of Symlin therapy. Concerns focused on safety issues, particularly upon issues involved with the initiation of therapy. Committee members requested that the company submit additional data to respond to safety concerns.
Advisory committees provide independent advice and recommendations to the FDA on scientific and technical matters related to the development and evaluation of regulated products. The FDA itself makes the final decisions.
GlaxoSmithKline announced in late July that it has substantially changed the appearance of container labeling in an effort to reduce the potential for dispensing errors involving the tablet form of its antiepileptic drug, Lamictal (lamotrigine).
The most common dispensing errors have been between Lamisil, an antifungal tablet manufactured by Novartis Pharmaceutical Corp., and Lamictal. In these instances, either Lamisil was substituted for Lamictal or Lamictal was substituted for Lamisil. GlaxoSmithKline has received reports of prescription dispensing errors involving Lamictal and other medications including lamivudine, Ludiomil, labetalol, and Lomotil.
To more clearly differentiate Lamictal from other prescription products on pharmacists’ shelves, the following packaging changes have been implemented:
• The Lamictal proprietary name has been modified visually to minimize potentially confusing syllables.
• Use of different color labels distinguishes the different tablet strengths of Lamictal from each other as well as other drugs.
• The following message has been added to the label, "CAUTION: Verify Product Dispensed."
• The bottle cap has been changed from white to yellow.
The small incremental improvements to existing drugs that make up the majority of the new drug approvals by the Food and Drug Administration each year provide important health benefits to patients, especially elderly ones, according to a study released in July by the Center for Pharmaceutical Health Services Research at Temple University in Philadelphia.
Newer drugs in a therapeutic class often have fewer side effects, have improved drug safety and effectiveness, and are used more easily, which facilitates compliance with prescribed treatments, the study says. A wide variety of product alternatives permit treatments to be better tailored to individual patient needs.
In addition to improving health outcomes, products entering the market that represent incremental innovations over their predecessors often are less expensive than existing agents in a therapeutic class, the study says. The result is less expensive alternatives long before generic products are available.