Pediatric rule legislation passes Congress

The U.S. House of Representatives has overwhelmingly approved legislation that will require pharmaceutical companies to test specific medicines for use in children. Endorsed by the American Academy of Pediatrics (AAP) in Washington, DC, the Pediatric Research Equity Act (S. 650/H.R. 2857) passed the Senate on July 23 by unanimous consent, and was then introduced in the House by Reps. Jim Greenwood (R-PA), Anna Eshoo (D-CA), and Deborah Pryce (R-OH). President Bush is expected to sign the bill.

The Pediatric Rule is a complement to the Best Pharmaceuticals for Children Act, a law that gives financial incentives to pharmaceutical companies that voluntarily decide to test drugs in children. The Pediatric Rule covers medicines not covered by that law.

Last October, a judge struck down the rule, saying Congress hadn’t given the Food and Drug Administration (FDA) the authority to require companies to test medications in children. Immediately following the court decision, the AAP asked Congress to act quickly to enact legislation granting the FDA authority and restoring the rule.


Aggressive atorvastatin therapy halts progression of atherosclerosis

Aggressive atorvastatin treatment stopped progression of plaque burden in heart patients in a head-to-head trial that compared moderate with aggressive statin therapy. The trial aimed to lower levels of low-density lipoprotein (LDL) to below 80 mg/dL.

Principal investigator Steven E. Nissen, MD, FACC, vice chairman of the Department of Cardiology at the Cleveland (OH) Clinic Foundation, presented these results from the Reversal of Atherosclerosis with Lipitor (REVERSAL) study, on Nov. 12 at the American Heart Association’s Scientific Sessions 2003. The information here was reported by Medscape and WebMD.

The study compared two cholesterol-lowering drugs, atorvastatin (Lipitor) and pravastatin (Pravachol), in more than 500 patients with symptomatic coronary artery disease. Lowering LDL cholesterol to an average of 79 mg/dL stopped progression of clogged arteries among patients taking 80 mg atorvastatin, Nissen says. The progression was measured by intravascular ultrasound.

However, taking 40 mg pravastatin did not offer the same slowing effect on heart disease even though some patients were able to achieve the same super-low LDL levels. Heart disease in the pravastatin-treated patients was about 3% worse after 18 months of treatment. Lipitor’s manufacturer, Pfizer, sponsored the study.


New indications for valganciclovir HCl tablets

The U.S. Food and Drug Administration and Roche Laboratories are notifying health care professionals of the findings of an active comparator study of valganciclovir HCl tablets (Valcyte) and ganciclovir in heart, liver, kidney, and kidney-pancreas transplant patients at high risk for cytomegalovirus (CMV) disease.

Based on those findings: 1) Valganciclovir HCl is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk; 2) Valganciclovir HCl is not indicated for use in liver transplant patients; and 3) The safety and efficacy of valganciclovir HCl for the prevention of CMV disease in other solid organ transplant patients, such as lung transplant patients, have not been established.

For more information, read the "Dear Health-care Professional" letter at: www.fda.gov/medwatch/SAFETY/2003/safety03.htm#valcyte.


Aventis warns of hepatic injury reports with leflunomide (Arava)

Aventis Pharmaceuticals is warning of reports of hepatic injury with the use of leflunomide (Arava), which is indicated for the treatment of active rheumatoid arthritis.

Rare and serious hepatic injury, including cases with fatal outcomes, has been reported in postmarketing experience worldwide, Aventis says. Most cases occurred within six months of therapy and in a setting of multiple risk factors for hepatotoxicity. Rare postmarketing reports of severe infections, including sepsis, which may be fatal, also were received. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness, which, in addition to rheumatoid disease, may predispose patients to infection.

For more information, see www.fda.gov/medwatch/SAFETY/2003/arava_deardoc.pdf.


Seniors most vulnerable to hospital medication errors

More than one-third of hospital medication errors that reach the patient involve seniors, indicating that they continue to be a vulnerable population in U.S. health care facilities. This information comes from the United States Pharmacopeia (USP) in Rockville, MD. The USP recently released its fourth annual national report summarizing the most recent data collected by MEDMARXSM, the anonymous national medication error-reporting database operated by USP.

The MEDMARX data report, "Summary of Information Submitted to MEDMARX in the Year 2002: The Quest for Quality," provides an analysis of 192,477 medication errors as voluntarily reported by 482 hospitals and health care facilities nationwide, including community, government, and teaching institutions. MEDMARX is the nation’s largest database of medication errors, containing more than 530,000 released records. By the end of the third quarter of 2004, the number of records in the MEDMARX database will approach 1 million.

The 2002 MEDMARX data report revealed a number of significant findings with regard to the senior population, including:

  • A majority (55%) of fatal hospital medication errors reported involved seniors.
  • Almost 10% of the medication errors that caused harm to seniors were prescribing errors.
  • When harm occurred, wrong route (7%), such as a tube feeding given intravenously, and wrong administration technique (6.5%), such as not diluting concentrated medications, were the second and third most common errors among those ages 65 and older.
  • Omission errors (43%), improper dose/quantity errors (18%), and unauthorized drug errors (11%) were the most common types of medication errors among seniors.

The 2002 MEDMARX data report also found that incorrect administration technique continues to be responsible for the largest number of harmful medication errors (6.2%). This occurs when medications are either incorrectly prepared or administered, or both. Examples include not diluting concentrated medications, crushing sustained-released medications, wrong eye application of eye drops, and using incorrect IV tubes for medicine administration.