Drug & Device News

Manufacturer Recalls Infusion Pumps

Baxter Healthcare has recalled its COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163. These electronic infusion pumps are used to deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural, or other direct line into the bloodstream. The product was recalled because a software irregularity causes the newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm, display an error code and stop the infusion. The manufacturer advises immediate removal from service of all the affected triple channel pumps. COLLEAGUE customers with questions about the product may contact Baxter Medical Delivery Services at 1-800-843-7867.

Defibrillator Suit Settles

Boston Scientific announced July 13 that it had entered into an agreement to settle a number of product liability suits related to Guidant Corp. heart defibrillator devices. Boston Scientific acquired Guidant Corp. in 2006. The settlement calls for Boston Scientific to pay the approximate 4,000 plaintiffs in the U.S. District Court for the District of Minnesota Multi-District Litigation (MDL) a total of $195,000 million to settle claims that Guidant Corp. concealed information about the devices' propensity to malfunction. At least seven users of the devices allegedly died because of the devices' failure to deliver the shock required to jump-start a malfunctioning heart.

Vioxx'-Use Damage Seen Sooner Than Previously Reported

A report published July 26 in the New England Journal of Medicine says the increased risk of cardiovascular disease that reportedly occurs after 18 months of use of Vioxx actually sets in by 12 months of use. Kerr, D., et al.: Rofecoxib and Cardiovascular Adverse Events in Adjuvant Treatment of Colorectal Cancer, N Engl J Med, Vol. 357:360-369, Jul 26, 2007, Number 4.

The study's lead author, David Kerr of the University of Oxford in England, worked with 10 other researchers in a study of 2434 patients designed to explore whether Vioxx or a placebo did a better job of halting progression of colon cancer. The study found that 23 patients suffered a stroke or heart attack. Of those, 16 were Vioxx users, eight of whom were stricken within 12 months of taking the painkiller.

Plaintiffs' lawyers have been arguing for some time that the risk of injury from Vioxx use begins well before 18 months, but Merck consistently claimed that there was no scientific evidence of this. Says plaintiff attorney Michael Ferrara Jr. of the Ferrara Law Firm in Cherry Hill, NJ, 'It undercuts what Merck's lawyers have been saying about no harm until 18 months.' Ferrara says the plaintiffs' bar has tried to get the study published for 'several years and Merck has fought us at every turn.' Another Vioxx plaintiffs' lawyer, Benedict Morelli of New York, says, 'What's important ' is that juries will find out that Merck has not been straightforward about the heart risks of Vioxx.'

The newly released findings may lead to the filing of more suits among shorter-term Vioxx users in states, such as New York, that have a three-year statute of limitations. In states with shorter statutes of limitations that opportunity may have passed. Merck, of Whitehouse Station, NJ, is already facing more than 27,000 Vioxx suits. Of the 15 cases that have gone to trial in state and federal courts nationwide, Merck has won 10 and lost five.

Studies Say Antidepressant Use Lowers Suicide Risk

The American Journal of Psychiatry has published a pair of studies that contradict the current trend toward blaming antidepressant use for increased suicide attempts in patients. Simon, G., et al.: Suicide Attempts Among Patients Starting Depression Treatment with Medications or Psychotherapy. Am J Psychiatry 164:1029-1034, July 2007; Gibbons, R., et al.: Relationship Between Antidepressants and Suicide Attempts: An Analysis of the Veterans Health Administration Data Sets, Am J Psychiatry 164:1044-1049, July 2007.

The study, led by Seattle's Center for Health Study's Dr. Gregory E. Simon, looked at patterns of suicide attempts in outpatient populations of varying ages receiving depression medication or psychotherapy. It concluded that suicidal acts occurred most often in the month before the start of treatment, decreased in the month after treatment began and decreased further as treatment continued, regardless of patient age. The other study, led by Robert D. Gibbons of the Center for Health Statistics at the University of Illinois at Chicago, similarly found that patient suicide attempts prior to receipt of serotonin reuptake inhibitor (SSRI) drug therapy were significantly greater in number than after such treatments began, and that there exists no valid evidence to support the theory that SSRI treatment creates a greater risk of suicide in adult psychiatric patients.

OxyContin' Executives Reach Deal

Three executives at Purdue Pharma, the company that marketed the highly addictive painkiller OxyContin, pleaded guilty in May to misdemeanor charges of misbranding the drug. The company was alleged to have marketed their drug to doctors without fully warning them of its addictive qualities. Before pleading to the crime, the three executives struck an agreement with prosecutors that would allow them to avoid jail time, but victims of the drug and their families wanted that agreement thrown out.

On July 20, following a hearing in which families of overdose victims testified to their losses, the three executives ' the company's former president, its former medical director and one of its attorneys ' received sentences of three-years' probation and were ordered to perform community service at drug treatment facilities.

FDA Authorizes Limited Use of Zelnorm'

In March of this year the FDA asked On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm (tegaserod maleate) ' which is used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) ' to suspend its U.S. marketing of the product because of evidence that use of Zelnorm could increase patients' risk for heart attack, stroke, and unstable angina. However, the FDA relented slightly when it announced July 27 that it would permit the restricted use of Zelnorm under a treatment investigational new drug (IND) protocol, which will allow certain patients not enrolled in a clinical trial to be treated with the drug. To be eligible for the exception, patients must be females under the age of 55, with IBS-C or CIC, whose physicians decide the drug is medically necessary. Patients must also sign consent forms that indicate they have been informed of the potential risks and benefits of Zelnorm. For further information, go to: www.fda.gov/bbs/ topics/NEWS/2007/NEW01673.html.

Manufacturer Recalls Infusion Pumps

Baxter Healthcare has recalled its COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163. These electronic infusion pumps are used to deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural, or other direct line into the bloodstream. The product was recalled because a software irregularity causes the newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm, display an error code and stop the infusion. The manufacturer advises immediate removal from service of all the affected triple channel pumps. COLLEAGUE customers with questions about the product may contact Baxter Medical Delivery Services at 1-800-843-7867.

Defibrillator Suit Settles

Boston Scientific announced July 13 that it had entered into an agreement to settle a number of product liability suits related to Guidant Corp. heart defibrillator devices. Boston Scientific acquired Guidant Corp. in 2006. The settlement calls for Boston Scientific to pay the approximate 4,000 plaintiffs in the U.S. District Court for the District of Minnesota Multi-District Litigation (MDL) a total of $195,000 million to settle claims that Guidant Corp. concealed information about the devices' propensity to malfunction. At least seven users of the devices allegedly died because of the devices' failure to deliver the shock required to jump-start a malfunctioning heart.

Vioxx'-Use Damage Seen Sooner Than Previously Reported

A report published July 26 in the New England Journal of Medicine says the increased risk of cardiovascular disease that reportedly occurs after 18 months of use of Vioxx actually sets in by 12 months of use. Kerr, D., et al.: Rofecoxib and Cardiovascular Adverse Events in Adjuvant Treatment of Colorectal Cancer, N Engl J Med, Vol. 357:360-369, Jul 26, 2007, Number 4.

The study's lead author, David Kerr of the University of Oxford in England, worked with 10 other researchers in a study of 2434 patients designed to explore whether Vioxx or a placebo did a better job of halting progression of colon cancer. The study found that 23 patients suffered a stroke or heart attack. Of those, 16 were Vioxx users, eight of whom were stricken within 12 months of taking the painkiller.

Plaintiffs' lawyers have been arguing for some time that the risk of injury from Vioxx use begins well before 18 months, but Merck consistently claimed that there was no scientific evidence of this. Says plaintiff attorney Michael Ferrara Jr. of the Ferrara Law Firm in Cherry Hill, NJ, 'It undercuts what Merck's lawyers have been saying about no harm until 18 months.' Ferrara says the plaintiffs' bar has tried to get the study published for 'several years and Merck has fought us at every turn.' Another Vioxx plaintiffs' lawyer, Benedict Morelli of New York, says, 'What's important ' is that juries will find out that Merck has not been straightforward about the heart risks of Vioxx.'

The newly released findings may lead to the filing of more suits among shorter-term Vioxx users in states, such as New York, that have a three-year statute of limitations. In states with shorter statutes of limitations that opportunity may have passed. Merck, of Whitehouse Station, NJ, is already facing more than 27,000 Vioxx suits. Of the 15 cases that have gone to trial in state and federal courts nationwide, Merck has won 10 and lost five.

Studies Say Antidepressant Use Lowers Suicide Risk

The American Journal of Psychiatry has published a pair of studies that contradict the current trend toward blaming antidepressant use for increased suicide attempts in patients. Simon, G., et al.: Suicide Attempts Among Patients Starting Depression Treatment with Medications or Psychotherapy. Am J Psychiatry 164:1029-1034, July 2007; Gibbons, R., et al.: Relationship Between Antidepressants and Suicide Attempts: An Analysis of the Veterans Health Administration Data Sets, Am J Psychiatry 164:1044-1049, July 2007.

The study, led by Seattle's Center for Health Study's Dr. Gregory E. Simon, looked at patterns of suicide attempts in outpatient populations of varying ages receiving depression medication or psychotherapy. It concluded that suicidal acts occurred most often in the month before the start of treatment, decreased in the month after treatment began and decreased further as treatment continued, regardless of patient age. The other study, led by Robert D. Gibbons of the Center for Health Statistics at the University of Illinois at Chicago, similarly found that patient suicide attempts prior to receipt of serotonin reuptake inhibitor (SSRI) drug therapy were significantly greater in number than after such treatments began, and that there exists no valid evidence to support the theory that SSRI treatment creates a greater risk of suicide in adult psychiatric patients.

OxyContin' Executives Reach Deal

Three executives at Purdue Pharma, the company that marketed the highly addictive painkiller OxyContin, pleaded guilty in May to misdemeanor charges of misbranding the drug. The company was alleged to have marketed their drug to doctors without fully warning them of its addictive qualities. Before pleading to the crime, the three executives struck an agreement with prosecutors that would allow them to avoid jail time, but victims of the drug and their families wanted that agreement thrown out.

On July 20, following a hearing in which families of overdose victims testified to their losses, the three executives ' the company's former president, its former medical director and one of its attorneys ' received sentences of three-years' probation and were ordered to perform community service at drug treatment facilities.

FDA Authorizes Limited Use of Zelnorm'

In March of this year the FDA asked On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm (tegaserod maleate) ' which is used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) ' to suspend its U.S. marketing of the product because of evidence that use of Zelnorm could increase patients' risk for heart attack, stroke, and unstable angina. However, the FDA relented slightly when it announced July 27 that it would permit the restricted use of Zelnorm under a treatment investigational new drug (IND) protocol, which will allow certain patients not enrolled in a clinical trial to be treated with the drug. To be eligible for the exception, patients must be females under the age of 55, with IBS-C or CIC, whose physicians decide the drug is medically necessary. Patients must also sign consent forms that indicate they have been informed of the potential risks and benefits of Zelnorm. For further information, go to: www.fda.gov/bbs/ topics/NEWS/2007/NEW01673.html.