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FDA adds heart benefit to simvastatin (Zocor) label
The U.S. Food and Drug Administration (FDA) has announced changes to the labeling for simvastatin (Zocor), based on the results of the Heart Protection Study (HPS). The new labeling will reflect research showing that simvastatin is effective in reducing risks of fatal and non-fatal heart attacks and strokes, and in reducing the need for bypass surgery and angioplasty. The FDA approved simvastatin in 1991 to lower cholesterol. Merck and Co. manufactures the drug.
HPS was a double-blind, placebo-controlled study conducted in 20,536 patients. Men and women with heart disease or at high risk because of diabetes, peripheral arterial disease, or a history of stroke or other cerebrovascular disease were treated with either simvastatin 40 mg/day or placebo for an average of five years. The average age of patients entering HPS was 64, and the average level at baseline of low-density lipoprotein C, or "bad" cholesterol, was 131 mg/dL. The trial population included a large number of diabetics and elderly patients.
The risk of death from coronary heart disease was reduced by 18% in the patients treated with simvastatin. The risk of having a non-fatal heart attack was reduced by 38% in this group. Simvastatin also reduced the risk of stroke by 25% and the need for undergoing coronary or non-coronary revascularization procedures by 30% and 16%, respectively.
Pharmacists needed for underserved populations
The National Health Service Corps (NHSC) is launching a demonstration project, for this year only, to award loan repayment to a special group of pharmacists and chiropractors who agree to serve underserved populations in primary care health professional shortage areas throughout the United States. A minimum two-year service commitment is required, and applicants must be employed by a primary health care site that has an active NHSC clinician on staff who is authorized to prescribe medications.
Awardees will be part of a three-year trial program that will include an evaluation to determine whether adding chiropractors and pharmacists would enhance the effectiveness of the NHSC. Applications are due by June 30, 2003. For more information, go to http://nhsc.bhpr.hrsa.gov/.
APhA releases bulletin on gabapentin (Neurontin)
The American Pharmacists Association in Washington, DC, has published a New Therapeutics Bulletin on gabapentin (Neurontin) for pharmacists. The U.S. Food and Drug Administration recently approved gabapentin for the management of postherapeutic neuralgia in adults.
The bulletin, supported by an educational grant from Pfizer, provides a comprehensive description of the pharmacokinetics, dosing, administration, efficacy, adverse effects, cautions, use in pregnancy, and drug interactions associated with gabapentin. Postherapeutic neuralgia also is discussed. Additional information about gabapentin is posted on www.pharmacist.com under the link "Drug Information."
Smallpox compensation bill becomes law
On April 30, President Bush signed into law the Smallpox Emergency Personnel Protection Act of 2003 (HR 1770). The compromise bill was created to compensate individuals with vaccinia-related injuries. Under the law, people who are permanently disabled are eligible for up to $50,000 annually in lost wages, with no cap on the amount of damages they can collect during their lifetime. Partially disabled recipients also are eligible for up to $50,000 per year in lost wages, with a cap of $262,100. Spouses of recipients killed by the vaccine receive $262,100, while spouses with children choose between a $262,100 lump sum or $50,000 annually until the youngest child turns age 18.
The legislation will be funded by $42 million included in the FY 2003 supplemental appropriations bill.
In addition, the Secretary of the Department of Health and Human Services (HHS) has announced that the department will release $100 million to the states to help them better prepare for a possible smallpox attack and strengthen the public health infrastructure.
The money from HHS’ Centers for Disease Control and Prevention will be made available immediately. These funds are in addition to the $1.1 billion in fiscal year 2002 funds sent to states last year, and the $1.4 billion in fiscal year 2003 money.
PhRMA plans to report counterfeit drugs to FDA
The Pharmaceutical Research and Manufacturers of America (PhRMA) in Washington, DC, has announced that it has launched a voluntary program to report counterfeit drugs to the U.S. Food and Drug Administration (FDA).
Under the voluntary program, PhRMA member companies agree to notify the FDA’s Office of Criminal Investigations by telephone or in writing within five working days of determining that there is a reasonable basis to believe that a product has been counterfeited. The program also applies to counterfeits discovered in foreign countries if there is clear evidence that the counterfeits are intended for distribution in the United States. The reporting program went into effect on May 1.
The FDA commended PhRMA’s announcement. "This formal collaborative agreement will strengthen the FDA’s ability to assure the safety and effectiveness of drugs used by Americans," says FDA commissioner Mark B. McClellan, MD, PhD. Both the FDA and PhRMA will assess the value of this program at the end of one year.