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 [...]
Potentially Fatal Heart Rhythms With Azithromycin
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
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 [...]
Anemia Drug Omontys Recalled
Affymax and Takeda, the manufacturers of Omontys (Peginesatide) are issuing a voluntary recall of the drug due to life threatening and fatal events reported in patients receiving Omontys. This voluntary recall is being conducted with the knowledge of the FDA (Food and Drug Administration), who approved the drug in March of 2012. In a statement, [...]
Codeine Use In Children | FDA Boxed Warning
Codeine use in certain children after surgery can cause death “In August 2012 , FDA announced it was reviewing the safety of codeine due to cases of deaths and serious adverse events in children who took the drug after a tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine.” The FDA drug information [...]
Medtronic Infuse Bone Graft
Medtronic the manufacturer of Infuse is accused of manipulating information about it’s product. Infuse acts as the scaffold in a surgical bone grafting procedure. Infuse is a two part system consisting of a protein found in the body, and a sponge manufactured from a cow type 1 collagen. The sponge releases the protein over time [...]