Nearly 50 doctors across the United States sent an open letter to the U.S. Food and Drug Administration on Monday calling on the agency to “revise or rescind” its position on a controversial device that had been used on more than 50,000 women annually until the agency cautioned against it last year.
The device, known as a laparoscopic power morcellator, had been widely used to remove benign growths known as fibroid tumors from the uterus or to completely remove the uterus itself in a hysterectomy.
Serious concerns arose, however, when deadly cancer cells harbored in the fibroids of some women were dispersed throughout the abdomen once shredded by the blades. Some fibroids hide rare and dangerous leiomyosarcomas, an aggressive cancer that can prove difficult to treat.
To my pharmacist and doctor friends – you might want to to take a look at this article. The FDA studied 7 cases and found that confusion was resulting because the strength of individual ingredients displayed on Zerbaxa’s vial labels and carton labeling was different. Some of the cases studied showed that this was resulting in a 50% over-administration of the drug.
The FDA issued a warning to parents and medical personnel that the probiotic ABC Dophilus Powder has been linked to the death of an infant. The FDA warning states, in part, that:
“A premature infant administered a dietary supplement, ABC Dophilus® Powder (Solgar®), as part of in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the moldRhizopus oryzae and died.”
The FDA further cautions parents and medical personnel about the use of dietary supplements containing live bacteria or yeast in infants and adults that have a compromised immune system. Parents should be aware that the FDA does not monitor these types of drugs in the same manner as most pharmaceuticals. The FDA also does not ensure that these types of drugs do what the manufacturer claims.
I know that my wife and I frequently gave our children probiotic medicines when they were infants. I also know that I would have never done this had I known the risks associated.
Want to read the FDA’s warning letter? Click on this link:
Image Credit: Wall Street Journal
J&J just announced that it is voluntarily pulling its power morcellators globally. J&J’s decision comes in the wake of the FDA’s April 2014 warning to doctors that this device may spread, and consequently accelerate, the growth of undetected cancer cells in women. The FDA found that as many as 1 in 350 woman who undergo this procedure may have cancer that this machine could spread outside the uterus.
Power morcellators are robots that are used to preform minimally invasive robotic hysterectomies. The American Medical Association estimates that as many as 20,000 woman have these types of procedures preformed on an annual basis.
Our firm is currently reviewing cases where woman have had robotic hysterectomies and experienced injuries or the spread of cancer.
Bloomberg News published a good article on this: http://www.bloomberg.com/news/2014-07-31/j-j-withdraws-hysterectomy-device-tied-to-cancer-spread.html
The FDA just notified health professionals and caregivers of infants that prescription oral viscous lidocaine (2% solution) should not be used to treat infants and children with teething pain. The FDA will now require a “Boxed Warning” to the drug labeling that will highlight this warning.
This year the FDA reviewed 22 case reports of serious adverse reactions in infants and children. The adverse reactions noted were seizures, severe brain damage, heart problems, and even death. The age range for the reviews was 5 months to 3.5 years old.
The FDA further advised that viscous lidocaine should NOT be prescribed by doctors, and warned parents that even over-the-counter topical medications should not be used due to potential harmful side effects.
You can find the FDA’s Drug Safety Communication Notice here: http://www.fda.gov/Drugs/DrugSafety/ucm402240.htm
You can find the FDA’s Consumer Update Notice here: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm385817.htm
June 2, 2014 – Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. This recall has been initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris. This lot was distributed only in the U.S.
The recalled lots pose a potential safety risk to patients in two general areas: immune reaction and blood clots. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.
The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A.
Soliris is primarily used in treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare and life-threatening disorders. If you or a loved one is being treated for either condition, make sure your doctor is aware of this recall.
You can find the FDA Recall Notice here: http://www.fda.gov/Safety/Recalls/ucm399527.htm
The FDA announced yesterday the launch of “openFDA” website. This website will allow you to search over 3 million reported adverse drug side effects dating back to 2004.
Here is how the FDA envisions it being a very usual tool for you:
According to FDA’s Chief Health Informatics Officer, Dr. Taha Kass-Hout, “Using this data, a mobile developer could create a search app for a smart phone, for example, a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug.” Dr. Kass-Hout further stated, “OpenFDA will make our publicly available data accessible in a structured, computer-readable format.” It provides a “search-based” Application Programming Interface – the set of requirements that govern how one software application can talk to another – that makes it possible to find both structured and unstructured content online.
This is an incredibly important first step in making it easy for consumers to both report adverse side effects and to check to see if anyone else has experienced similar reactions. It also allow the FDA and drug manufacturers to monitor patient side effects and issue more accurate drug warnings or decide whether or not a safety recall is warranted. This database could essentially create a social media outlet for patients to anonymously report side effects – informing other users of previously unreported reactions.
Previously, only adverse side effects reported to the FDA or the manufacturer (assuming the manufacturer actually passed this information on to the FDA) were made public. And, even then, a consumer would have to search the FDA website for reported side-effects to find this information – a task that is cumbersome at best.
You can find the openFDA website here: http://open.fda.gov/index.html
FDA just issued a warning to healthcare professionals that Lunesta can cause lingering effects resulting in next-day impairment. The FDA has recommended that doctors advise patients to decrease their starting dose of Lunesta to 1 mg at bedtime. Both women and men have been reported to be equally effected. The previous recommended dosage of Lunesta was 3 mg which was found to possibly effect a patients driving skills, memory, and coordination up to eleven hours after taking a nightly dose.
To read the entire article from Drugs.com click here: http://www.drugs.com/fda/eszopiclone-containing-sleep-aids-safety-communication-can-cause-next-day-impairment-13545.html?utm_source=ddc&utm_medium=email&utm_campaign=FDA+Alert+-+Drug+Safety+Communication%3A+Eszopiclone+Containing+Sleep+Aids+-+Can+Cause+Next-Day+Impairment
To read the FDA’s Safety Announcement click here: http://www.fda.gov/Drugs/DrugSafety/ucm397260.htm
Nathan T. Williams, Attorney at Law