The FDA has issued a Class I recall for the Arrow multi-lumen venous catheterization set with a blue FlexTip ARROWg+ard catheter.  These catheters are used to administer drug therapy after being inserted into a large vein.  The label of the product incorrectly states that the catheter “contains no medication.”

The catheterization sets actually contain silver sulfadiazine as well as chlorhexidine.   If a patient with an allergy or sensitivity, known or unknown, to either substance is exposed, they risk the possibility of adverse health consequences or even death.  An allergic reaction to either can present as a delayed rash or hives or more immediately as Type 1, IgE mediated anaphylaxis. Such anaphylaxis manifests as loss of blood pressure, broncospasm, and vascular collapse. 

Arrow sent out a letter on May 3^rd, 2012 to all distributors of the sets urging them to quarantine the entirety of the designated product supply.  The distributors were then to alert their Arrow sales representatives to replace the labels in order to properly warn potential patients.

A new drug safety communication by the FDA has updated risks of the drug Ampyra (dalfampridine) which is approved to improve walking in those with Multiple Sclerosis. Currently, the drug label lists seizures as a side effect but the FDA is now in the process of updating the label to clarify recommendations. 

Based on post-market adverse event reports, the FDA has found that most seizures happen within days to weeks of beginning the recommended dosage of Ampyra- even in those with no history of seizure.  Because the drug is eliminated from the body through the kidneys, kidney impairment may develop higher blood levels of the drug.  Higher blood levels would then lead to an increased risk for seizures. 

The update of the drug label will note that Ampyra should not be used by those who have a history of seizures or who have moderate to severe renal impairment.  Before being prescribed the drug, health care professionals should assess renal function of the patient by estimating their creatine clearance.  Moderate to severe kidney impairment is measured as less than or equal to 50 mL/min. 

If you think you have been injured by a defective drug or device, contact one of our experienced products liability attorneys at Arias Ozzello & Gignac for important legal advice.

Recent studies have linked the drug finasteride, marketed by Merck and Co. to treat male pattern baldness (Propecia) and enlarged prostate (Proscar), to a host of sexual side effects including problems with libido, ejaculation, and orgasm.  These side effects, recently added to the FDA’s warning for the drug, have the potential to last for months or even years after discontinuing use, according to a study newly published in the Journal of Sexual Medicine.

Dr. Michael Irwig‘s study surveyed 54 men under the age of 40 who, after stopping Propecia, reported experiencing side effects lasting for three months or more that included erectile dysfunction, low libido, trouble having an orgasm, and shrinking and painful genitals.The study reported that 96% of the men surveyed had these sexual problems for more than a year.  While it is true that the sample size of the survey was small and perhaps only included those men who were negatively affected by the drug, the authors maintain that the findings may signal significant risk for men using finasteride.

The FDA updated the warning labels for finasteride after reviewing several hundred post-marketing reports.  Despite the updated warnings, however, both the FDA and Merck maintain the safety and efficacy of the drug.

The defective drug attorneys at Arias, Ozzello & Gignac are currently researching claims against Merck for Propecia’s adverse side effects. If you or someone you know has experienced complications from taking Propecia, call our experienced attorneys today for a free consultation. You may be entitled to compensation for your damages.

In the aftermath of increasing reports of addiction and abuse, Vicodin and other hyrdrocodone-combination painkillers may soon face stricter regulation by the Food and Drug Administration. The agency announced on June 7, 2012 that its advisers will meet in October to discuss the various applications of hydrocodone drugs vis-à-vis the risks associated with these drugs' use. Hydrocodone’s current status as the second-most abused drug in the United States, only marijuana exceeds it in terms of the rate of misuse, coupled with the fact that emergency room visits related to hydrocodone misapplication and recreational use more than doubled between 2004 and 2010, prompted the FDA to reconsider its categorization of the class of drugs. The FDA’s October conference seeks to change the drugs' classification to a level that requires increased oversight by doctors, thus making hyrodcodone-combination painkillers more difficult to obtain. Under current classifications, the DEA lists the opioid hydrocodone as a Schedule II controlled substance, the second-highest level on a five-stage scale that takes into account the potential for addiction. Hydrocodone combinations, such as Abbott Laboratories’ Vicodin, rank one class lower and, as a result, have fewer restrictions on sales.