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FDA ISSUES PUBLIC HEALTH ADVISORY ABOUT NEW LABELING FOR ANTIDEPRESSANTS
The Food and Drug Administration issued a Public Health Advisory to inform the public about the increased risk of suicidality (suicidal thoughts and behavior) among pediatric patients being treated with antidepressants.

"Our conclusions are based on the latest and best science," said Dr. Lester Crawford, acting commissioner of the FDA. "They reflect what we heard from our advisory committee last month, as well as what many members of the public have told us."

The regulatory agency directed all antidepressant drug manufacturers to revise the labeling for their products. All antidepressants must now include a "black box" warning about the risk of suicidality among young patients and recommendations for closely monitoring them. The new labeling will also outline the uses for which the drug is and is not indicated as well as results from pooled analyses of relevant trials.

While the FDA said that depression and other psychiatric disorders can have significant consequences if they are not appropriately treated in children and adolescents, it added, "The new warning language recognizes this need but advises close monitoring of patients as a way of managing the risk of suicidality."

Additionally, the FDA is developing a Patient Medication Guide or MedGuide, which will be given to all treated patients in order to inform them of the risk and precautions for antidepressant use. The guides are intended to be distributed by pharmacists when prescriptions are filled or re-filled. The agency said it plans to work with manufacturers to implement "unit of use" packaging, or a method of preparing the drug in an original container that is sealed and pre-labeled by the manufacturer, to ensure patients receive a MedGuide with the drug every time.

These actions follow those recommended by the FDA's Psychopharmacologic Drugs Advisory Committee and Pediatric Drugs Advisory Committee in a meeting last month.



FDA REQUESTS ADDITIONAL CLINICAL TRIAL OF RIQUENT; LA JOLLA SHARES PLUMMET
Shares of La Jolla Pharmaceutical Co. dropped more than 60 percent Friday after the Food and Drug Administration said it would not approve the firm's drug Riquent (abetimus sodium) until the firm completes an additional double-blind study demonstrating the clinical benefit of the product.

La Jolla said the letter it received from the FDA indicated that the firm's ongoing trial of Riquent, which was initiated in August of this year, "would appear to satisfy this requirement." Analysts, however, are skeptical about La Jolla's ability to complete the study.

"We do not believe that LJPC has sufficient financing to complete the ongoing confirmatory clinical study," Pacific Growth Equities told its clients, according to CBS MarketWatch. "We believe that the ability of LJPC to garner sufficient financing to complete this or another potentially suitable study is also uncertain."

Pacific Growth said the study would take three to four years to complete and cost approximately $25 million. According to Reuters, the trial involves 500 to 600 patients who will be treated for one year.

Riquent is designed to treat lupus patients who have renal disease and has received an orphan drug designation from the FDA.

La Jolla shares closed at $1.09, down $1.67, in heavy trading on the Nasdaq.

PFIZER WILL CONDUCT LONG-TERM CARDIOVASCULAR STUDIES OF BEXTRA, UPDATE LABEL TO REFLECT SKIN-REACTION RISK
Pfizer Inc. said Friday it plans to conduct long-term studies to examine the cardiovascular safety of its COX-2 inhibitor Bextra (valdecoxib) and is working with regulatory authorities to update the Bextra label to reflect the risk of a rare but serious skin reaction.

After Merck & Co. Inc.'s COX-2 inhibitor Vioxx (rofecoxib) was withdrawn from the market last month due to increased cardiovascular risk, Pfizer examined its clinical trial database for Bextra, which includes 8,000 patients treated for durations ranging from six to 52 weeks. Pfizer said the review indicated no increased risk of cardiovascular thromboembolic events in patients treated for osteoarthritis or rheumatoid arthritis.

However, data from two trials involving individuals undergoing coronary artery bypass graft surgery showed patients treated with Bextra (alone or in combination with Pfizer's experimental, injectable COX-2 inhibitor parecoxib) had an increased incidence of cardiovascular events. Separate studies in general surgery showed no increased risk of cardiovascular thromboembolic events. Pfizer emphasized that Bextra is not approved in the United States for use in any surgical setting.

Pfizer said it will conduct further studies to confirm the long-term cardiovascular safety profile of Bextra in patients who require chronic treatment for arthritis.

Additionally, Pfizer sent a letter to health care professionals to alert them of the risk of a rare but serious skin reaction with Bextra. Bextra's label has included information on the condition since its introduction in 2002. However, Pfizer said it will update the label to show that the risk of this condition is greater with Bextra than with other COX-2 inhibitors and that the risk is greatest during the first two weeks of Bextra therapy.

Pfizer also markets the COX-2 inhibitor Celebrex (celecoxib).

Shares of Pfizer dropped $0.56, or 1.9 percent, to close at $28.52 on the New York Stock Exchange.



SERONO'S LUVERIS APPROVED BY FDA
Serono SA received Food and Drug Administration approval for its Luveris (lutropin alfa for injection) to be used in combination with the firm's Gonal-f (follitropin alfa for injection) to stimulate follicular development in infertile, hypogonadotropic hypogonadal (HH) women who have profound luteinizing hormone (LH) deficiency.

Serono said HH is a rare endocrine deficiency in which women are unable to produce the hormones needed for full development of follicles in the ovaries, ovulation and growth of the lining of the uterus sufficient to support implantation of a fertilized egg and early pregnancy.

Luveris is the first recombinant form of LH to receive approval from the FDA, making Serono the only company to market three recombinant fertility hormones in the United States. Serono said it will complete a phase-out of its older-generation urinary products (with the exception of the Japanese market) by the end of 2004.

Luveris has been designated an orphan drug by the FDA. According to Reuters, analysts expect the product to generate peak annual sales in the range of $40 million to $50 million worldwide.

PATIENTS LOSE WEIGHT, EXPERIENCE IMPROVEMENT, RESOLUTION OF DIABETES, HYPERTENSION AND SLEEP APNEA AFTER BARIATRIC SURGERY
After patients who were morbidly obese underwent bariatric surgery, they lost weight and a majority experienced resolution or improvement of their diabetes, hyperlipidemia, hypertension and obstructive sleep apnea, a recent meta-analysis showed.

The investigators evaluated 136 fully extracted primary studies, which included 91 kin studies and 22,094 patients who underwent the procedure. Patient age was an average 38.97 years, and the average baseline body mass index for 16,944 of the patients was 46.85.

For 10,172 patients, the overall percentage of excess weight loss for all surgery types was 61.2 percent. At the outcome time point, the average percentage of excess weight loss was 47.5 percent for gastric banding, 61.6 percent for gastric bypass, 68.2 percent for gastroplasty and 70.1 percent for biliopancreatic diversion or duodenal switch.

Mortality at 30 days or less was 0.1 percent for the restrictive procedures (banding and gastroplasty), 0.5 percent for gastric bypass procedures and 1.1 percent in biliopancreatic diversion or duodenal switch procedures.

Of the studies that reported both resolution and improvement or only improvement of diabetes, 85.4 percent of 485 patients achieved resolution or improvement.

Typically, 70 percent or more of patients showed significant improvements in hyperlipidemia, hypercholesterolemia and hypertriglyceridemia across all surgery types. Total cholesterol level, low-density lipoprotein cholesterol level and level of triglycerides significantly dropped.

Moreover, hypertension improved or resolved in 78.5 percent of patients across surgeries; 83.6 percent of patients experienced a resolution or improvement in obstructive sleep apnea.

This literature review appeared in the Oct. 13 issue of JAMA.

CHIROPRACTIC COVERAGE IN MANAGED CARE PLANS MAY BE RELATED TO COST SAVINGS, NEW ANALYSIS INDICATES
Access to managed chiropractic care may be clinically beneficial and result in lower annual medical costs for health plan members, according to a new study published in the Oct. 11 issue of Archives of Internal Medicine.

Using administrative claims data on 1.7 million members from the same large regional managed care network in California, researchers retrospectively compared patterns of 707,690 plan members who had access to chiropractic insurance coverage with the remaining 1 million members who were without such coverage between April 1, 1997, and March 31, 2001.

Members with chiropractic coverage had lower annual total health care expenditures ($1,463 per member per year [PMPY]) compared with those without coverage ($1,671 PMPY), which translates to a 12 percent reduction in annual costs for members with chiropractic coverage.

Access to chiropractic care was also linked with a 1.6 percent statistically significant reduction in annual health care costs at the health plan level.

The average cost of providing care for back pain for patients with chiropractic coverage was $289 per episode, which was 28 percent lower than the cost for those without access to chiropractic care.

Compared with those without coverage, results showed that per 1,000 episodes back pain patients with chiropractic coverage had significantly lower utilization rates for plain radiograph (22.7 vs. 17.5), low back surgery (4.8 vs. 3.3 surgical procedures), hospitalizations (15.6 vs. 9.3 inpatient stays) and magnetic resonance imaging (68.9 vs. 43.2).

In an accompanying editorial appearing in the same issue of Archives, two authors wrote that the findings shed "considerable light" on the cost-effectiveness of chiropractic care for insured patients.

"Nevertheless, critical questions remain regarding which subsets of patients could derive the most benefit from chiropractic care and yet incur fewer health expenditures. Once these questions are answered, we will have moved one step closer to success in the daunting task of managing back pain," they said.



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SECRETARY OF HEALTH AND HUMAN SERVICES TOMMY THOMPSON
Secretary of Health and Human Services Tommy Thompson said it is "doubtful" that doses of influenza vaccine will be imported to ease the shortage created when Chiron Corp.'s manufacturing plant in the United Kingdom was shut down earlier this month. Since vaccines other than those made by Chiron, the sanofi-aventis Group and MedImmune Inc. have not been approved for use in the United States, meeting Food and Drug Administration requirements for use in time for the upcoming flu season is unlikely. Thompson said it is possible some supplies could meet conditions to allow them to be used as experimental vaccine, but even that process may take too long.

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BOSTON SCIENTIFIC CORP.
Boston Scientific Corp. will not be subjected to any regulatory action from the Food and Drug Administration regarding Boston Scientific's recall of approximately 100,000 coronary stents earlier this year, according to an FDA official cited by The Associated Press. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said the agency's review supports Boston Scientific's contentions that it has fixed the flaw that led to the recall and that the stents now on the market are safe.

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DR. REDDY'S LABORATORIES LTD.
Dr. Reddy's Laboratories Ltd. received tentative approval from the Food and Drug Administration for its generic version of Merck & Co. Inc.'s hair-loss drug Propecia (finasteride), according to Reuters. U.S. sales of the drug totaled approximately $112 million during the 12 months ended in March, Reuters said.

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GIVEN IMAGING
Given Imaging reported worldwide third-quarter sales of its Given Diagnostic System and PillCam SB video capsule increased 50 percent year-over-year to more than $14.5 million. Analysts, however, were expecting sales of $15.06 million, on average, according to Reuters Estimates. Given shares closed Friday at $38.90, down $5.18, or 11.8 percent, in heavy trading on the Nasdaq.  

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