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