Drug & Device News

Merck to Settle Vioxx Claims?

The New York Times reported Nov. 9 that pharmaceuticals manufacturer Merck has agreed to settle for a total of $4.85 billion claims brought against it by Vioxx users. Berenson, The New York Times, 11/9/07. The offer will have to be approved by most of the thousands of plaintiffs who have filed individual and class action lawsuits claiming the drug carried heart attack and stroke risks that Merck knew of but did not disclose to doctors or the public.

 

Cochlear Implants Raise Risk Of Contracting Bacterial Meningitis

The Cochlear Implant device, which allows the deaf and severely hard-of hearing to hear, is now being associated with increased risk for bacterial meningitis. The Food and Drug Administration advises that implants with positioner components create the greatest risk. Cochlear Implants with positioners were withdrawn from the market in 2002, but many people are still implanted with them.

Two deaths from bacterial meningitis have been reported, both in children with cochlear implants with positioners who had not been fully vaccinated against the illness. Health care professionals are being advised to ensure that recipients of these devices are fully immunized according to the Centers for Disease Control (CDC) vaccination recommendations. Among these is the recommendation that Cochlear Implant users receive pneumococcal vaccination under the same schedules that apply to other individuals at high risk for invasive pneumococcal disease. Vaccination schedule recommendations are available on the CDC's Web site at http://www.cdc.gov/vaccines/vpd-vac/mening/cochlear/discochlear-hcp.htm. They apply to all children with a Cochlear Implant, with or without a positioner, and to all potential implant recipients.

 

Defibrilator Leads Pulled From Shelves

On Oct. 14, Medtronic Inc. announced that it was voluntarily withdrawing from the market its Sprint Fidelis' heart defibrillator leads because of the potential for lead fractures. When these leads, or electronic wires, fracture, they can cause defibrillators to administer unnecessary shocks or to stop working completely. The company estimates that approximately 268,000 of its Sprint Fidelis leads have been implanted into patients.

The market withdrawal was prompted by reports of five deaths as well as other patient health complications that may be linked to malfunctioning Sprint Fidelis leads. Health care facilities with these devices still on their shelves are being advised to return them to Medtronic, although the company advises that patients who have been implanted with the leads should retain them due to the risks associated with removal. For further information, see the manufacturer's Web site at: http://wwwp.medtronic.com/http://wwwp.medtronic.com/ Newsroom/NewsReleaseDetails.do?itemId=1192213397218&lang=en_US.

 

Deaths from Micro-bubble Contrast Agents Prompt Call for Warning Change

Following reports of 11 deaths following administration of ultrasound micro-bubble contrast agents used in echocardiography, the FDA is asking manufacturers to change their 'Boxed Warnings' for these products.

Micro-bubble ultrasound contrast agents are a sterile suspension of perflutren gas microspheres used in patients with suboptimal echocardiograms. The recommended new warnings will tell health care providers that patients receiving micro-bubble contrast agents should be monitored for serious cardiopulmonary reactions during the infusion and for 30 minutes afterward, and that the products should not be used in patients with unstable angina, acute myocardial infarction, respiratory failure or recent worsening congestive heart failure.

 

New FDA Chief Counsel Named

Gerald F. Masoudi, former U.S. Department of Justice deputy assistant attorney general, has been appointed chief counsel for the U.S. Department of Health and Human Services' Food and Drug Division, which handles FDA legal matters. Prior to his move into the government service sector, Masoudi was a partner at Chicago-based firm Kirkland & Ellis.

 

Diabetes Drug Tied to Pancreatic Inflammation

Thirty postmarketing reports of acute pancreatitis in patients taking type-2 diabetes drug Byetta' have been reported to the FDA. The agency is therefore now instructing health care providers that they should discuss the symptoms of pancreatitis with patients taking Byetta. Patients taking the drug who experience unexplained severe and persistent abdominal pain, with or without vomiting, should be told to seek medical attention immediately. Byetta's manufacturer, Amylin Pharmaceuticals Inc., has agreed to include new information about the risks of contracting pancreatitis in the 'Precautions' section of the drug's label.

 

FDA Panel Concerned About Children's Over-the-Counter Cold Meds

Over-the-counter pediatric cough and cold medications are coming under fire from medical experts and consumer advocates who say that not only have the products not been proven effective, they can be dangerous and even deadly for young children, especially those under two years of age. Prompted by the recent outcry over child deaths and injuries following use of these medications, an FDA advisory panel was convened to take testimony and consider whether they should be banned. After two days of testimony and deliberations, the panel recommended that over-the-counter cold medications for children under six years of age be banned.

In an apparent attempt to appease their critics, several manufacturers a week prior to the advisory panel's meeting had voluntarily pulled infant and toddler versions of their cold medications off the market, including some decongestants sold under the PediaCare', Dimetapp', Robitussin' and TYLENOL' labels. To some, the manufacturers' and FDA panel's moves were too little, too late. For example, consumer advocacy group Public Citizen is urging parents not to give cough and cold medications to children under age 12. 'Children Under 12 Should Not Be Given Cough, Cold Medications, Public Citizen Tells FDA,' http://www.citizen.org/pressroom/release.cfm?ID=2529 (last accessed 10/23/07). The FDA's advisory panel specifically rejected a ban on over-the-counter cold medications for these older children.

 

ED Drugs May Cause Hearing Loss, New Labels Warn

A small number of patients taking erectile dysfunction (ED) drugs in the class known as phosphodiesterase type 5 (PDE5) inhibitors have reported experiencing sudden hearing loss in conjunction with their use. In about a third of the 29 reported cases the hearing loss was temporary, but the other two-thirds of affected patients either did not regain their hearing abilities or their recoveries were not reported to the FDA's Adverse Events Reporting System.

Included in the PDE5 class of drugs are ED medications Cialis', Levitra', and Viagra', as well as Revatio', a drug used to treat pulmonary arterial hypertension (PAH). The FDA has approved revisions to the warning labels on these drugs that will emphasize the risks and advise patients and physicians of actions they should take if sudden hearing loss occurs. For further information, go to: http://www.citizen.org/pressroom/release.cfm?ID=2529.gov/bbs/top ics/NEWS/2007/NEW01730.html.

Merck to Settle Vioxx Claims?

The New York Times reported Nov. 9 that pharmaceuticals manufacturer Merck has agreed to settle for a total of $4.85 billion claims brought against it by Vioxx users. Berenson, The New York Times, 11/9/07. The offer will have to be approved by most of the thousands of plaintiffs who have filed individual and class action lawsuits claiming the drug carried heart attack and stroke risks that Merck knew of but did not disclose to doctors or the public.

 

Cochlear Implants Raise Risk Of Contracting Bacterial Meningitis

The Cochlear Implant device, which allows the deaf and severely hard-of hearing to hear, is now being associated with increased risk for bacterial meningitis. The Food and Drug Administration advises that implants with positioner components create the greatest risk. Cochlear Implants with positioners were withdrawn from the market in 2002, but many people are still implanted with them.

Two deaths from bacterial meningitis have been reported, both in children with cochlear implants with positioners who had not been fully vaccinated against the illness. Health care professionals are being advised to ensure that recipients of these devices are fully immunized according to the Centers for Disease Control (CDC) vaccination recommendations. Among these is the recommendation that Cochlear Implant users receive pneumococcal vaccination under the same schedules that apply to other individuals at high risk for invasive pneumococcal disease. Vaccination schedule recommendations are available on the CDC's Web site at http://www.cdc.gov/vaccines/vpd-vac/mening/cochlear/discochlear-hcp.htm. They apply to all children with a Cochlear Implant, with or without a positioner, and to all potential implant recipients.

 

Defibrilator Leads Pulled From Shelves

On Oct. 14, Medtronic Inc. announced that it was voluntarily withdrawing from the market its Sprint Fidelis' heart defibrillator leads because of the potential for lead fractures. When these leads, or electronic wires, fracture, they can cause defibrillators to administer unnecessary shocks or to stop working completely. The company estimates that approximately 268,000 of its Sprint Fidelis leads have been implanted into patients.

The market withdrawal was prompted by reports of five deaths as well as other patient health complications that may be linked to malfunctioning Sprint Fidelis leads. Health care facilities with these devices still on their shelves are being advised to return them to Medtronic, although the company advises that patients who have been implanted with the leads should retain them due to the risks associated with removal. For further information, see the manufacturer's Web site at: http://wwwp.medtronic.com/http://wwwp.medtronic.com/ Newsroom/NewsReleaseDetails.do?itemId=1192213397218&lang=en_US.

 

Deaths from Micro-bubble Contrast Agents Prompt Call for Warning Change

Following reports of 11 deaths following administration of ultrasound micro-bubble contrast agents used in echocardiography, the FDA is asking manufacturers to change their 'Boxed Warnings' for these products.

Micro-bubble ultrasound contrast agents are a sterile suspension of perflutren gas microspheres used in patients with suboptimal echocardiograms. The recommended new warnings will tell health care providers that patients receiving micro-bubble contrast agents should be monitored for serious cardiopulmonary reactions during the infusion and for 30 minutes afterward, and that the products should not be used in patients with unstable angina, acute myocardial infarction, respiratory failure or recent worsening congestive heart failure.

 

New FDA Chief Counsel Named

Gerald F. Masoudi, former U.S. Department of Justice deputy assistant attorney general, has been appointed chief counsel for the U.S. Department of Health and Human Services' Food and Drug Division, which handles FDA legal matters. Prior to his move into the government service sector, Masoudi was a partner at Chicago-based firm Kirkland & Ellis.

 

Diabetes Drug Tied to Pancreatic Inflammation

Thirty postmarketing reports of acute pancreatitis in patients taking type-2 diabetes drug Byetta' have been reported to the FDA. The agency is therefore now instructing health care providers that they should discuss the symptoms of pancreatitis with patients taking Byetta. Patients taking the drug who experience unexplained severe and persistent abdominal pain, with or without vomiting, should be told to seek medical attention immediately. Byetta's manufacturer, Amylin Pharmaceuticals Inc., has agreed to include new information about the risks of contracting pancreatitis in the 'Precautions' section of the drug's label.

 

FDA Panel Concerned About Children's Over-the-Counter Cold Meds

Over-the-counter pediatric cough and cold medications are coming under fire from medical experts and consumer advocates who say that not only have the products not been proven effective, they can be dangerous and even deadly for young children, especially those under two years of age. Prompted by the recent outcry over child deaths and injuries following use of these medications, an FDA advisory panel was convened to take testimony and consider whether they should be banned. After two days of testimony and deliberations, the panel recommended that over-the-counter cold medications for children under six years of age be banned.

In an apparent attempt to appease their critics, several manufacturers a week prior to the advisory panel's meeting had voluntarily pulled infant and toddler versions of their cold medications off the market, including some decongestants sold under the PediaCare', Dimetapp', Robitussin' and TYLENOL' labels. To some, the manufacturers' and FDA panel's moves were too little, too late. For example, consumer advocacy group Public Citizen is urging parents not to give cough and cold medications to children under age 12. 'Children Under 12 Should Not Be Given Cough, Cold Medications, Public Citizen Tells FDA,' http://www.citizen.org/pressroom/release.cfm?ID=2529 (last accessed 10/23/07). The FDA's advisory panel specifically rejected a ban on over-the-counter cold medications for these older children.

 

ED Drugs May Cause Hearing Loss, New Labels Warn

A small number of patients taking erectile dysfunction (ED) drugs in the class known as phosphodiesterase type 5 (PDE5) inhibitors have reported experiencing sudden hearing loss in conjunction with their use. In about a third of the 29 reported cases the hearing loss was temporary, but the other two-thirds of affected patients either did not regain their hearing abilities or their recoveries were not reported to the FDA's Adverse Events Reporting System.

Included in the PDE5 class of drugs are ED medications Cialis', Levitra', and Viagra', as well as Revatio', a drug used to treat pulmonary arterial hypertension (PAH). The FDA has approved revisions to the warning labels on these drugs that will emphasize the risks and advise patients and physicians of actions they should take if sudden hearing loss occurs. For further information, go to: http://www.citizen.org/pressroom/release.cfm?ID=2529.gov/bbs/top ics/NEWS/2007/NEW01730.html.