Drug & Device News

More Cases Link Meningococcal Vaccine and Guillain Barr' Syndrome

On Oct. 20, the FDA and the Centers for Disease Control and Prevention (CDC) updated a previous alert to consumers and health care providers regarding reports of Guillain Barr' Syndrome (GBS) following administration of Meningococcal Con-jugate Vaccine A, C, Y, and W135 (trade name Menactra'), manufactured by sanofi pasteur. In addition to the five cases the FDA reported in October 2005, the new alert announced that 12 more such cases have developed. Fifteen of the 17 cases reported to date involved children 11-19 years old, and all these subjects developed GBS within six weeks of vaccination.

GBS is a rare neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in leg, arm and other muscles that can be severe and require hospitalization. It usually resolves on its own but some people may have residual neurological problems.

The sanofi pasteur studies, conducted before Menactra was approved for general use, involving 7000 vaccine recipients, showed no relationship between the use of the vaccine and GBS. The FDA also reports that an analysis of Menactra use within the Vaccine Safety Datalink, a database of vaccine information from eight managed care organizations, has shown no link between the vaccine and GBS in children 11-19 years old. Therefore, the agency has made no changes in recommendations for vaccination while it continues to monitor the situation.

Better Monitoring of Device Performance in Store?

The American Association of Trial Lawyers (ATLA) sent comments to the FDA on Nov. 9 urging the agency to track medical devices so that medical care givers and consumers can be efficiently informed when problems with devices arise. Said ATLA chief executive officer Jon Haber in a release, 'The big pharmaceutical and medical device industries have spent millions of dollars to evade accountability at the expense of patient safety. Requiring the industries to track devices is a simple move that will protect those whose lives depend on the proper functioning of devices.' The ATLA's comments were offered in response to the FDA's notice requesting information about how the use of a unique device identification (UDI) system for medical devices may improve patient safety. See 71 Fed. Reg. 46233. To see the ATLA's comments, go to: www.atla.org/pressroom/PressReleases/2006/nov9.aspx.

That same day, the Postmarket Transformation Leadership Team, a group assembled in January by the FDA's Center for Devices and Radiological Health (CDRH) to study how to improve the monitoring of the safety of medical devices once on the market, announced its recommendations to the FDA. Included in the plan for strengthening the postmarket program are suggestions that the agency create a unique identifier system that will allow every device to be tracked over its lifetime and that a mandatory electronic reporting system for making adverse event reports be instituted. The group also wants more coordination to occur between the agency's compliance and enforcement programs. For further information or a copy of the 'Postmarket Transformation Leadership Team: Strengthening FDA's Postmarket Program for Medical Devices' report, go to: www.fda.gov/cdrh/postmarket/mdpi.html.

Silicone Breast Implants Are Back

Two companies, Mentor Corp. and Allergan Corp., were given the go-ahead in November to market silicone breast implants. These devices were taken off the market 14 years ago amid concerns that they were leaking and perhaps causing autoimmune reactions, cancer and other ailments. Many of these fears were later determined to be unfounded, but not in time to save device maker Dow Corning from bankruptcy brought about by lawsuits against it. The FDA noted in its approval announcement that several problems remain with the devices, including the fact that they will probably need replacement at some time in a woman's life and that, when they do leak, women and their doctors will generally be unable to tell without the aid of MRI screenings. The FDA recommends that women begin screenings three years after receiving the implants and that they continue to get them every two years after that. As conditions of approval, the companies will be required to conduct a ten-year follow-up study of patient outcomes as well as continue studying the devices for failure potential in the laboratory setting.

Anemia Medication Found Dangerous When Overused

A study published in the Nov. 16 edition of The New England Journal of Medicine ' titled Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) ' found that kidney patients not yet on dialysis who receive more than the recommended doses of epoetin (sold under the names Procrit', Epogen' and Aranesp') to treat anemia are at increased risk of experiencing heart attacks, heart failures and strokes. It has been asserted that dialysis clinics, which make little or no profit from their many dialysis patients on medicare, over-prescribe epoetin to increase their profit margins. See Berenson, The New York Times, 11/16/06. In light of the report, the FDA on Nov. 16 issued an advisory to health care providers asking them to follow the recommendations on the product's labeling and to test their patients' blood hemoglobin levels frequently. Patients were also warned that they should promptly report to their doctors any shortness of breath or pain or swelling in the legs.

Study Says Stents Not Right For All

An article published in the Dec. 7 edition of The New England Journal of Medicine, titled 'Coronary Intervention for Persistent Occlusion after Myocardial Infarction,' suggests that the routine implantation of stents in high-risk patients whose heart valve blockage emergencies have passed (implantation being performed at 3-28 days following myocardial infarction) may be unnecessary. The study observed 2166 patients, about half of whom were given percutaneous coronary intervention and stenting along with optimal medical therapy while the other half received optimal medical therapy alone. After four years, the group without stents actually fared slightly better. The bottom-line conclusion is that the risks and costs of the stent implant procedure in patients whose emergency situations have passed are probably not outweighed by the potential advantages to the patient's future health.

Another Contact Lens Solution Maker Recalls Products

Advanced Medical Optics Inc. voluntary recalled several lots of 12-ounce COMPLETE' Moisture PLUS-(TM) multipurpose contact lens care solution and Active Packs in Novem-ber. The recalled products were manufactured at a plant in China that also supplied the same solutions to Japan, where bacteria have been found in the products. The list of affected lots can be found at www.fda.gov/oc/po/firmrecalls/advmedical11_06.html. This move follows recalls in recent months of similar products manufactured by Bausch & Lomb that caused infections in users. Based on these problems, attorneys nationwide are currently recruiting plaintiffs for possible suits against Bausch & Lomb.

More Cases Link Meningococcal Vaccine and Guillain Barr' Syndrome

On Oct. 20, the FDA and the Centers for Disease Control and Prevention (CDC) updated a previous alert to consumers and health care providers regarding reports of Guillain Barr' Syndrome (GBS) following administration of Meningococcal Con-jugate Vaccine A, C, Y, and W135 (trade name Menactra'), manufactured by sanofi pasteur. In addition to the five cases the FDA reported in October 2005, the new alert announced that 12 more such cases have developed. Fifteen of the 17 cases reported to date involved children 11-19 years old, and all these subjects developed GBS within six weeks of vaccination.

GBS is a rare neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in leg, arm and other muscles that can be severe and require hospitalization. It usually resolves on its own but some people may have residual neurological problems.

The sanofi pasteur studies, conducted before Menactra was approved for general use, involving 7000 vaccine recipients, showed no relationship between the use of the vaccine and GBS. The FDA also reports that an analysis of Menactra use within the Vaccine Safety Datalink, a database of vaccine information from eight managed care organizations, has shown no link between the vaccine and GBS in children 11-19 years old. Therefore, the agency has made no changes in recommendations for vaccination while it continues to monitor the situation.

Better Monitoring of Device Performance in Store?

The American Association of Trial Lawyers (ATLA) sent comments to the FDA on Nov. 9 urging the agency to track medical devices so that medical care givers and consumers can be efficiently informed when problems with devices arise. Said ATLA chief executive officer Jon Haber in a release, 'The big pharmaceutical and medical device industries have spent millions of dollars to evade accountability at the expense of patient safety. Requiring the industries to track devices is a simple move that will protect those whose lives depend on the proper functioning of devices.' The ATLA's comments were offered in response to the FDA's notice requesting information about how the use of a unique device identification (UDI) system for medical devices may improve patient safety. See 71 Fed. Reg. 46233. To see the ATLA's comments, go to: www.atla.org/pressroom/PressReleases/2006/nov9.aspx.

That same day, the Postmarket Transformation Leadership Team, a group assembled in January by the FDA's Center for Devices and Radiological Health (CDRH) to study how to improve the monitoring of the safety of medical devices once on the market, announced its recommendations to the FDA. Included in the plan for strengthening the postmarket program are suggestions that the agency create a unique identifier system that will allow every device to be tracked over its lifetime and that a mandatory electronic reporting system for making adverse event reports be instituted. The group also wants more coordination to occur between the agency's compliance and enforcement programs. For further information or a copy of the 'Postmarket Transformation Leadership Team: Strengthening FDA's Postmarket Program for Medical Devices' report, go to: www.fda.gov/cdrh/postmarket/mdpi.html.

Silicone Breast Implants Are Back

Two companies, Mentor Corp. and Allergan Corp., were given the go-ahead in November to market silicone breast implants. These devices were taken off the market 14 years ago amid concerns that they were leaking and perhaps causing autoimmune reactions, cancer and other ailments. Many of these fears were later determined to be unfounded, but not in time to save device maker Dow Corning from bankruptcy brought about by lawsuits against it. The FDA noted in its approval announcement that several problems remain with the devices, including the fact that they will probably need replacement at some time in a woman's life and that, when they do leak, women and their doctors will generally be unable to tell without the aid of MRI screenings. The FDA recommends that women begin screenings three years after receiving the implants and that they continue to get them every two years after that. As conditions of approval, the companies will be required to conduct a ten-year follow-up study of patient outcomes as well as continue studying the devices for failure potential in the laboratory setting.

Anemia Medication Found Dangerous When Overused

A study published in the Nov. 16 edition of The New England Journal of Medicine ' titled Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) ' found that kidney patients not yet on dialysis who receive more than the recommended doses of epoetin (sold under the names Procrit', Epogen' and Aranesp') to treat anemia are at increased risk of experiencing heart attacks, heart failures and strokes. It has been asserted that dialysis clinics, which make little or no profit from their many dialysis patients on medicare, over-prescribe epoetin to increase their profit margins. See Berenson, The New York Times, 11/16/06. In light of the report, the FDA on Nov. 16 issued an advisory to health care providers asking them to follow the recommendations on the product's labeling and to test their patients' blood hemoglobin levels frequently. Patients were also warned that they should promptly report to their doctors any shortness of breath or pain or swelling in the legs.

Study Says Stents Not Right For All

An article published in the Dec. 7 edition of The New England Journal of Medicine, titled 'Coronary Intervention for Persistent Occlusion after Myocardial Infarction,' suggests that the routine implantation of stents in high-risk patients whose heart valve blockage emergencies have passed (implantation being performed at 3-28 days following myocardial infarction) may be unnecessary. The study observed 2166 patients, about half of whom were given percutaneous coronary intervention and stenting along with optimal medical therapy while the other half received optimal medical therapy alone. After four years, the group without stents actually fared slightly better. The bottom-line conclusion is that the risks and costs of the stent implant procedure in patients whose emergency situations have passed are probably not outweighed by the potential advantages to the patient's future health.

Another Contact Lens Solution Maker Recalls Products

Advanced Medical Optics Inc. voluntary recalled several lots of 12-ounce COMPLETE' Moisture PLUS-(TM) multipurpose contact lens care solution and Active Packs in Novem-ber. The recalled products were manufactured at a plant in China that also supplied the same solutions to Japan, where bacteria have been found in the products. The list of affected lots can be found at www.fda.gov/oc/po/firmrecalls/advmedical11_06.html. This move follows recalls in recent months of similar products manufactured by Bausch & Lomb that caused infections in users. Based on these problems, attorneys nationwide are currently recruiting plaintiffs for possible suits against Bausch & Lomb.