All Topics

• Bidding War for Guidant Heats Up

  Jamie Sheller | January 20, 2006 7:28 AM | 0 CommentsPhiladelphia, PA

  After Guidant Corporation appeared ready to give its full support to latest bid from Johnson and Johnson, Boston Scientific raised its bid for Guidant, with help from Abbott Laboratories. The new offer, at $80 a share, quickly got Guidant to switch its support from the Johnson and Johnson proposal to Boston Scientific. The two companies have recently been in a bidding war for Guidant, which...

• Safety Alert for Blood Testing Kit

  Jamie Sheller | January 16, 2006 7:44 AM | 0 CommentsPhiladelphia, PA

  The FDA and Ortho Clinical Diagnostics notified health care professionals of the recall of a blood testing kit. The HBsAg Confirmatory Kit is used to test blood for the Hepatitis B virus. An unknown component in the diluting solution may produce Not Confirmed results for samples found to be positive with the initial test. These false negative results could result in a lack of treatment for...

• More Trouble for Heart Device Manufacturer

  Jamie Sheller | January 03, 2006 8:37 AM | 0 CommentsPhiladelphia, PA

  Guidant Corporation recently received more bleak news from the FDA. Citing concerns about the manufacturing practices of the company, the FDA informed Guidant that it would not approve any more company devices for sale, nor will the FDA approve new contracts to export Guidant heart devices manufactured in its Minnesota plant.This news comes at a time when the company is still reeling from...

• Sales of Neutrospec Suspended

  Jamie Sheller | December 20, 2005 11:27 AM | 0 CommentsPhiladelphia, PA

  On December 19, 2005, Palatin Technologies suspended sales, marketing and distribution of Neutrospec, which is a radiolabeled imaging agent used primarily for diagnosing appendicitis. Serious adverse events, including two deaths, have been reported with the use of Neutrospec, which was approved for marketing in July 2004. After learning of the adverse events from Palatin, and meeting with the...

• Guidant Reports More Deaths Linked to Heart Devices

  Jamie Sheller | December 16, 2005 9:25 AM | 0 CommentsPhiladelphia, PA

  Guidant Corporation has provided the FDA with reports about several recent patient deaths connected to recalled Guidant heart devices. The new reports raise the number of deaths from those devices to seven. According to agency records, those deaths resulted from short circuits in the devices, and they occurred after Guidant issued a recall of several devices in June 2005. The electrical...

• Incomplete Fix for Silicone Gel Implants

  Jamie Sheller | December 16, 2005 9:20 AM | 0 CommentsPhiladelphia, PA

  Mentor Corp., a maker of silicone gel breast implants, is hoping for FDA approval to sell its implants for general cosmetic use. However, the implants have exhibited a problem of leaking silicone oil. A former engineer for Mentor told the FDA that when the company was alerted to the problem, it fixed the demonstration models of the implants that would be used in doctor offices, but not the...

• Paxil Linked to Birth Defects

  Jamie Sheller | December 15, 2005 7:54 AM | 0 CommentsPhiladelphia, PA

  New information indicates that pregnant women who suffer from mental illness, such as depression and panic disorder, must be careful when taking a particular drug used to treat such diseases. According to the FDA, exposure to paroxetine, also known as Paxil, in the first trimester of pregnancy, may increase the risk of birth defects, particularly cardiac malformations.The manufacturer of Paxil...

• Antipsychotic Drugs Raise Concern For Elderly

  Jamie Sheller | December 15, 2005 7:48 AM | 0 CommentsPhiladelphia, PA

  Antipsychotic drugs approved for use in treating mental illnesses such as schizophrenia and manic depression, are also used by doctors to treat patients with dementia, including Alzheimers disease. However, recently the newer antipsychotic drugs have been linked to an increased risk of death for older patients. But researchers caution against switching elderly patients to the older generation...

• Over-the-Counter Eye Drops and Pain Medication Pulled From Market

  Jamie Sheller | December 01, 2005 12:09 PM | 0 CommentsPhiladelphia, PA

  MBI Distributing, Inc. has been ordered to stop manufacturing its over-the-counter (OTC) eye drops and pain relief drugs. The FDA found that manufacturing deficiencies resulted in the company being unable to ensure that its eye drops were sterile. Also, the FDA determined that two of MBIs eye drop brands, Visitein and Clarity Vision for Life, are unapproved drugs. Further, the FDA found that...

• New Warnings Needed for Asthma Medications

  Jamie Sheller | December 01, 2005 12:06 PM | 0 CommentsPhiladelphia, PA

  The FDA has required new warnings for Advair Diskus, Foradil Aerolizer, and Serevent Diskus asthma medications. The manufacturers must alert health care providers and patients that these medications may increase the chance of severe asthma episodes, and death when those episodes occur. The affected products contain medicines known as long-acting beta 2-adrenergic agonists (LABA), which help...