Posts Tagged ‘Drug’

The U.S. Food and Drug Administration (FDA) and Edwards Lifesciences notified health care professionals, Nov. 9, about the Class 1 recall of CardioVations EndoClamp™ Aortic Catheter, model numbers EC1001 and EC65. The recall was initiated because the balloon catheters may spontaneously rupture during surgery.

This product was manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009.

The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.

On Oct. 29, 2009, the manufacturer sent a follow-up letter to their customers instructing them to:

• Check their inventory and identify any unused product; and 
• Return unused products to the company.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program.

The Food and Drug Administration (FDA) advised health care professionals Oct. 1 that a new version of heparin due to start shipping Oct. 8 is 10 percent less potent, and that this reduced potency could weaken its ability to prevent blood clots. Read more »

The Food and Drug Administration (FDA) issued a Public Health Advisory on transdermal drug patches after learning a warning was missing on certain patches containing aluminum or other metals in their non-adhesive backing. Such patches can cause burns if worn while undergoing magnetic resonance imaging (MRI) scans.

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Physicians will soon have a new treatment option to offer patients with overactive bladder (OAB). The Food and Drug Administration (FDA) approved a new topical gel designed to treat the symptoms of OAB Jan. 27.

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Health care professionals have an additional choice for treating patients with moderate to severe acute pain. The U.S. Food and Drug Administration (FDA) has approved Tapentadol hydrochloride, according to a Nov. 24 press release. Read more »

The U.S. Food and Drug Administration (FDA) seized 11 lots of contaminated heparin—a blood thinner drug—from Celsus Laboratories Inc. on Nov. 6, according to an FDA news release.

The 11 lots consisted of five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium. These products were manufactured in China and found to be contaminated with over-sulfated chondroitin sulfate (OSCS)—a substance that mimics heparin’s anticoagulant activity. Read more »

Should individuals be allowed to sue pharmaceutical manufacturers when adverse reactions not clearly identified on drug labels occur? A recent court case has brought that question up for debate again.

The White House and the FDA general counsel say no. Drug regulators and advocacy group leaders say yes. David G. Savage reports on this Oct. 30 story for the Los Angeles Times.

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration’s (FDA’s) Web site to find a wide variety of prescription drugs safety information. The Web page provides links to everything drug related—from information regarding drug labeling to drug-specific safety information, and much more.

Ucyclyd Pharma, Inc. has informed the U.S. Federal Food and Drug Administration (FDA) of particulate matter detected in their product Ammonul® (sodium phenylacetate and sodium benzoate) Injection. Until further notice, the manufacturer will supply Millex® Durapore GV 33 mm sterile syringe filters (0.22 µm) with the product, and advises clinicians to use the filters during the admixture process when injecting Ammonul into the 10-percent dextrose IV bag.

Ammonul Injection 10%/10% is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate used for treatment of acute hyperammonemia in urea cycle disorders.

The FDA released an alert Sept. 23 and asks that you report adverse events related to Ammonul Injection by phone (800) FDA-1088, fascimile (800) FDA-0178 or the Internet www.fda.gov/medwatch. You can also contact the manufacturer at (800) 900-6389.