Drug & Device News

FDA commissioner Lester Crawford abruptly resigned on Sept. 23, 2 months after his confirmation as FDA commissioner. Crawford claimed to be leaving because, at the age of 67, it was time for him to leave the post. President Bush named Andrew von Eschenbach, director of the National Cancer Institute (NCI), as acting FDA commissioner until a permanent appointment can be made. The President and CEO of the Pharma-ceutical Research and Manufacturers of America (PhRMA), Billy Tauzin, issued a statement commending the Bush administration for moving quickly and placing the FDA in good hands. “Dr. von Eschenbach has both strong research and management credentials,” said Tauzin. “His leadership, and the expertise of dedicated veteran FDA regulators, will allow the agency to continue its important work until a new commissioner is nominated and confirmed.” Von Eschenbach intends to continue in his position with the NCI while serving as acting commissioner of the FDA.

Stattera Warnings Issued

The FDA has issued an alert to physicians warning of reports of suicidal ideation in children and adolescents taking Strattera', a drug approved to treat attention deficit hyperactivity disorder (ADHD). The FDA is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed.

Birth Defects Prompt Antidepressant Warning Label Changes

GlaxoSmithKline (GSK) has advised physicians in a “Dear Healthcare Professional” letter that it is changing the Pregnancy subsection of the PRECAUTIONS section in the labels for PAXIL' (paroxetine HCl) and PAXIL CR' (paroxetine HCl) Controlled-Release Tablets. Paroxetine currently carries a Category C pregnancy precaution, indicating that there are no adequate and well-controlled studies in humans to determine the effect of paroxetine on the fetus. Labeling states that the drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. GSK recently conducted a retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy, the preliminary results of which suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared with other antidepressants. The types of congenital malformations most commonly observed were cardiovascular. GSK will post the results of this study to its Clinical Trial Register at http://ctr.gsk.co.uk/welcome.asp.

New Electronic Drug Information System Will Improve Safety

Beginning in November 2005, health care professionals, patients, and other consumers will be able to access information on medications via the Internet free of charge through the “Daily Med” system, which will receive, distribute and display medication information that has been developed by Federal agencies.

A key element of the Daily Med is the electronic product label, which is akin to a package insert. Currently, the content and format of paper package insert labels is not conducive to easy accessibility, and they are not easy to search for pertinent information, or even find on the web. The FDA plans to have all drug makers take part in this new system in order to create an electronic environment for drug safety and drug effectiveness information. To this end, the FDA is requiring drug makers to start submitting label changes electronically in a standard format that, after verification by the FDA, will make updating labels with new information seamless and automatic.

Possible Menactra/Guillain Barre Syndrome Connection

Five reports have been made of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra', manufactured by Sanofi Pasteur. Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization. The FDA issued an alert about the reports Sept. 30, but stressed that it is not known yet whether these cases of GBS were caused by the vaccine or are coincidental. The FDA and the Centers for Disease Control (CDC) are currently investigating the situation. According to Jesse Goodman, MD, Director of FDA's Center for Biologics Evaluation and Research, at the present time there are no changes in recommendations for vaccination.

Merck's Attorney Loses Cool

In the case brought by postal employee Frederick Humeston against Merck & Co. Inc. over injuries he claims to have suffered after taking the pain medication Vioxx, a shouting match occurred between Judge Carol E. Higbee and a Merck attorney after the judge ruled that the testimony offered by Merck scientist Dr. Briggs Morrison would not be allowed in evidence. Merck asked for a mistrial ruling following the decision, but that request was denied.

Another Step Taken Toward Approval of Silicone Breast Implant Sales

The FDA in September issued an approvable letter to Inamed Corp. for its premarket application (PMA) for silicone gel-filled breast implants. An approvable letter is one of several intermediate steps in the FDA review process of new products but it does not mean that Inamed's device is yet approved by the agency. Previously, at its April 2005 meeting, the FDA's General and Plastic Surgery Devices Advisory Panel recommended by a vote of 5 to 4 not to approve Inamed's PMA. Since then, Inamed has provided the FDA with additional information to address the primary safety concerns discussed by the panel. Inamed has also said that it will no longer make available its Style 153 device, which had raised particular safety issues for the panel.

FDA Gets New (Temporary) Chief

FDA commissioner Lester Crawford abruptly resigned on Sept. 23, 2 months after his confirmation as FDA commissioner. Crawford claimed to be leaving because, at the age of 67, it was time for him to leave the post. President Bush named Andrew von Eschenbach, director of the National Cancer Institute (NCI), as acting FDA commissioner until a permanent appointment can be made. The President and CEO of the Pharma-ceutical Research and Manufacturers of America (PhRMA), Billy Tauzin, issued a statement commending the Bush administration for moving quickly and placing the FDA in good hands. “Dr. von Eschenbach has both strong research and management credentials,” said Tauzin. “His leadership, and the expertise of dedicated veteran FDA regulators, will allow the agency to continue its important work until a new commissioner is nominated and confirmed.” Von Eschenbach intends to continue in his position with the NCI while serving as acting commissioner of the FDA.

Stattera Warnings Issued

The FDA has issued an alert to physicians warning of reports of suicidal ideation in children and adolescents taking Strattera', a drug approved to treat attention deficit hyperactivity disorder (ADHD). The FDA is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed.

Birth Defects Prompt Antidepressant Warning Label Changes

GlaxoSmithKline (GSK) has advised physicians in a “Dear Healthcare Professional” letter that it is changing the Pregnancy subsection of the PRECAUTIONS section in the labels for PAXIL' (paroxetine HCl) and PAXIL CR' (paroxetine HCl) Controlled-Release Tablets. Paroxetine currently carries a Category C pregnancy precaution, indicating that there are no adequate and well-controlled studies in humans to determine the effect of paroxetine on the fetus. Labeling states that the drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. GSK recently conducted a retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy, the preliminary results of which suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared with other antidepressants. The types of congenital malformations most commonly observed were cardiovascular. GSK will post the results of this study to its Clinical Trial Register at http://ctr.gsk.co.uk/welcome.asp.

New Electronic Drug Information System Will Improve Safety

Beginning in November 2005, health care professionals, patients, and other consumers will be able to access information on medications via the Internet free of charge through the “Daily Med” system, which will receive, distribute and display medication information that has been developed by Federal agencies.

A key element of the Daily Med is the electronic product label, which is akin to a package insert. Currently, the content and format of paper package insert labels is not conducive to easy accessibility, and they are not easy to search for pertinent information, or even find on the web. The FDA plans to have all drug makers take part in this new system in order to create an electronic environment for drug safety and drug effectiveness information. To this end, the FDA is requiring drug makers to start submitting label changes electronically in a standard format that, after verification by the FDA, will make updating labels with new information seamless and automatic.

Possible Menactra/Guillain Barre Syndrome Connection

Five reports have been made of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra', manufactured by Sanofi Pasteur. Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization. The FDA issued an alert about the reports Sept. 30, but stressed that it is not known yet whether these cases of GBS were caused by the vaccine or are coincidental. The FDA and the Centers for Disease Control (CDC) are currently investigating the situation. According to Jesse Goodman, MD, Director of FDA's Center for Biologics Evaluation and Research, at the present time there are no changes in recommendations for vaccination.

Merck's Attorney Loses Cool

In the case brought by postal employee Frederick Humeston against Merck & Co. Inc. over injuries he claims to have suffered after taking the pain medication Vioxx, a shouting match occurred between Judge Carol E. Higbee and a Merck attorney after the judge ruled that the testimony offered by Merck scientist Dr. Briggs Morrison would not be allowed in evidence. Merck asked for a mistrial ruling following the decision, but that request was denied.