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
April 30, 2013 By
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
April 25, 2013 By
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
April 23, 2013 By
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
April 16, 2013 By
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
April 8, 2013 By
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
March 29, 2013 By
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
March 27, 2013 By
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 [...]
Potentially Fatal Heart Rhythms With Azithromycin
March 13, 2013 By
An FDA drug safety communication about the risk of potentially fatal heart rhythms, when taking Azithromycin (Zithromax, Zmax, or Z Pack – prepackaged 5 day course of azithromycin), was issued today 3/12/2013 Azithromycin is a semi-synthetic macrolide antibiotic used to treat middle ear infections, tonsillitis, laryngitis, bronchitis, pneumonia, and sinusitis. It is also effective in [...]
Generic Drug Sulindac Causes Toxic Epidermal Necrolysis
March 7, 2013 By
Sulindac is the generic name for Clinoril, a drug similar to ibuprofen. Like ibuprofen, Sulindac is in a class of drugs known as Nsaids (Nonsteroidal Anti-inflammatory) drugs. In 2004, Ms. Karen Bartlett was prescribed Sulindac by her doctor to treat shoulder pain. In less than two weeks, Ms. Bartlett’s skin began to slough off. After [...]
