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.
Source: FDA warning on uterine device draws opposition from doctors | Newsday
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.
FDA Alert: Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication – FDA Cautions about Dose Confusion and Medication Errors.
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:
FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for weight loss.
Cleveland.com [http://www.cleveland.com/healthfit/index.ssf/2014/07/fda_warns_of_prescription_drug.html] reported that the FDA has warned consumers NOT to use the following weight loss supplements due to them containing a dangerous drug known to cause heart attacks and strokes:
1. Mix Fruit Slimming sold on Amazon
2. Lingzhi Cleansed Slim Tea sold on Amazon
3. Trim Fast
4. 24 ince
5. Sliming (sic) Diet by Pretty White sold on ebay
FDA’s List of additional products just for 2014 with “hidden drugs:”
You can watch the FDA’s video on “Tainted Weight Loss Products” here: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234592.htm.
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
On June 6, 2014, the FDA dropped its hammer on both the maker (Akrimax Pharmaceuticals) and the marketing company (Citius Pharmaceuticals) of the diet drug Suprenza. The website for Suprenza apparently completely failed to list ANY of the contraindications or adverse reactions. The FDA’s letter states that the website “fails to disclose any of the other warnings and precautions associated with the drug. By omitting serious and frequently occurring risks associated with Suprenza, the webpage misleadingly suggests that Suprenza is safer than has been demonstrated.”
The FDA letter further admonishes the website for implying that people taking Suprenza will become “lean.” The FDA states that it “is not aware of substantial evidence or substantial clinical experience to support this implication…” The FDA stated that such implication is misleading absent substantial proof, which apparently doesn’t exist for this drug.
This information was first reported by the Wall Street Journal, and can be found here: http://blogs.wsj.com/pharmalot/2014/06/16/a-diet-drug-website-is-lean-on-important-information-fda-says/.
You can read a complete copy of the FDA’s letter here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM400708.pdf
If you are considering taking Suprenza – Ask yourself why a manufacture would fail to disclose any of the known contraindications and adverse reactions and why it would attempt to mislead you. Then ask yourself is this really something I want to put in my body.
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
Fresenius Medical Care North America issued a recall for certain lots of NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters. NaturaLyte is drug used in hemodialysis machines. Laboratory test identified a Gram Negative bacteria (Halomonas). The FDA issued recall notices on May 21 and May 28th of this year. The FDA has received one report of death and two reports of injuries suspected to be related to the infected drug. The FDA further stated that the affected product could cause serious adverse health consequences, including sepsis, bacteremia, and death.
You can find the FDA recall notices here:
Nathan T. Williams
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