Safety Announcement [05-06-2013] “The U.S. Food and Drug Administration (FDA) is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there [...]
NuvaRing Hormones
NuvaRing is a form of birth control that is inserted vaginally to help prevent pregnancy NuvaRing is made of a flexible plastic that releases a low dose of progestin and estrogen directly into the body, resulting in a higher dose of hormones than what is delivered by oral birth control pills. NuvaRing increases the risk of [...]
Kcentra Approved For Reversal Of Coumadin Bleeds
Kcentra is a prothrombin concentrate used to treat or prevent blood or bleeding disorders Kcentra is manufactured by CSL Behring (Commonwealth Serum Laboratories), one of the worlds leading plasma protein biotherapeutics companies. Prothrombin Concentrate is a combination of blood clotting factors II, VII, IX, and X, as well as protein ‘C’ and ‘S’ that reverses [...]
Class 1 Recall Issued On Diabetic Blood Glucose Meter
A class 1 recall was issued on the LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter for failure to provide a warning at high glucose levels. A glucose meter is a medical device used to determine the approximate concentration of glucose in the blood. It helps people with diabetes mellitus or hypoglycemia monitor the level [...]
Recall On Balanced Solutions All Sterile Compounded Products
FDA MedWatch: “Balance Solutions Compounding Pharmacy, LLC announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired.” “During an FDA inspection of Balanced Solutions, investigators observed poor practices and conditions, which may have exposed the company’s sterile products to microbial contamination. The FDA’s preliminary findings of sterile [...]
Fentanyl Pain Patches
The FDA (Food and Drug Administration) is reminding patients who use “fentanyl transdermal system pain patches (Duragesic and its generics) to always store, use, and dispose of them carefully to prevent unintended poisonings and other harm, especially to children and pets.” Fentanyl should only be handled by the patient or the patient’s caregivers. Fentanyl is [...]
The OTC Morning After Pill
The OTC (Over The Counter) morning after pill is no longer restricted by age A federal judge rules that Plan B and Next Choice should be available to all, including minors. Plan B was first approved for use in 1999 by prescription only; the FDA granted over-the-counter access to the pill for women 18 and [...]
Physician Owned Distributorships Under Investigation
Physician owned distributorships (PODs) are companies that sell doctor owned medical devices. The doctors then use these devices in surgical procedures on their own patients. The concern being that when a doctor performs a surgery requiring an implantable medical device, also has an ownership interest in the device, fraud and abuse could be substantial. Because [...]
NuvaRing Trials Scheduled To Begin Mid-2013
As of March 2013, NuvaRing litigation filed in state and federal courts are comprised of over 1,250 individual lawsuits NuvaRing is birth control in the form of a non-oral hormonal contraception that is placed in the vagina once a month to prevent pregnancy. NuvaRing contains estrogen and progestin which thickens the cervical mucus and keeps [...]
GranuFlo | NaturaLyte Issued a Class One Recall FDA
GranuFlo and NaturaLyte are one part of a three part dialysate procedure used during dialysis. Dialysis is a process in which toxic waste is removed from the bloodstream by neutralizing acids that build up in the blood – basically replacing the function of the kidneys. GranuFlo and NaturaLyte (another dialysis product) were issued a class [...]