Aussie Company Faces FDA Accusation about Manufacturing Practices

udits carried out by the FDA in 2010 and 2011 revealed "objectionable conditions and practices" within CSL, the privatised Commonwealth Serum Laboratories, News Limited reported on Thursday.

Allegations include that CSL took six months to start investigating the cause of dark particles in the national stockpile of swine flu vaccines.

The FDA's most recent audit, carried out in March, found CSL's investigation of febrile fits among children immunised with Fluvax, its seasonal flu vaccine, was "inadequate".

Source here. 

Will the FDA Ask That Yaz Be Removed from the Market?

There are preliminary results that a FDA-funded study of Yaz and similar drospirenone-based contraceptives show they carry a 1.5-fold increase in the risk of  blood clots compared to older hormonal contraceptives. That study follows six others, four of which have shown an increased clot risk for Yaz and its ilk.
 
The DrugCite database of adverse event information culled from the FDA shows that blood-clot events are more common for pills containing drosperinone than for levonorgestrel, an older version of the progestin ingredient in contraceptive pills:

• Most Common Drospirenone Adverse Events
  
• Pulmonary Embolism: 119
• Deep Vein Thrombosis: 99
• Gallbladder Injury: 57
• Thrombosis: 20
• Most Common Levonorgestrel Adverse Events
• Pulmonary Embolism: 17
• Deep Vein Thrombosis: 10
• Thrombosis: 9
• Gallbladder Injury: 0

Source here

FDA Recalls Several Medtronic SynchroMed II Infusion Pumps

The FDA has asked for a recall of Medtronic's SynchroMed II implantable infusion pump, models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.

From the FDA site:


Product: SynchroMed II Implantable Infusion Pump, models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.
Medtronic has a Device Identification web page where customers can enter the serial number for any SynchroMed II infusion pump to determine if their pump is being recalled.

Use: The SynchroMed II Implantable Programmable Drug Pump is part of the SynchroMed II Infusion system designed to contain and administer prescribed drugs to a specific site. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is indicated when patient therapy requires the chronic infusion of the drugs or fluids. This infusion pump is indicated to deliver morphine sulfate, ziconotide and baclofen for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. It is also indicated for delivery of floxuridine and methotrexate for the treatment of primary or metastatic cancer.

Recalling Firm:
Medtronic, Inc – Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568

Reason for Recall:
There is a potential for reduced battery performance in the SynchroMed II infusion Pump. Medtronic’s analysis of the problem indicates it is related to the formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms. For example, patients receiving intrathecal baclofen therapy for severe spasticity are at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not treated quickly and effectively.

Medtronic encourages patients to carry their patient identification cards with them at all times and to contact their physicians immediately if they experience a return of symptoms or hear a device alarm.
SynchroMed II infusion pumps were recalled for the same battery issue in July 2009.

Lawsuit over Bone Deterioration Allegedly Caused by Nexium filed in Texas

Good work by the folks at Pharmalot.

Lawsuit was filed alleging  that AstraZeneca is to blame for bone deterioration and bone fractures allegedly attributed to the Nexium acid reflux pill.

Read more here.  

Public Citizen: Time to Recall the Surgical Mesh

Mesh products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence, Public Citizen, based in Washington, said in a statement today. The mesh is implanted through incisions made in the wall of the vagina to reinforce the tissues around the pelvic organs.

Public Citizen says that 67,500 women had the non-absorbable mesh implanted last year. The FDA has  1,503 reports of complications associated with the material from January 2008 to December 2010 when used to repair pelvic organ prolapse, the agency said in a safety warning July 13.

http://www.bloomberg.com/news/2011-08-25/fda-should-recall-surgical-mesh-for-women-public-citizen-says.html

Birth Control Pill Recall

Qualitest Pharmaceuticals, an oral contraceptive manufacturer, has announced a recall of several varieties of birth control pills due to a packaging error that may be affecting users' dosage schedules.


In the affected birth control pill packages, the card used to track dosage is misaligned and may result in women taking the hormone-free "filler" pills on days when they should be taking active pills. "Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible," a Food and Drug Administration (FDA) statement says.


More here