FDA Medwatch-Drug Safety Labeling Changes

03/14/2016 The FDA MedWatch-February 2016 Safety Labeling Changes includes 21 products with safety labeling changes to the following sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE. The “Summary Page” table provides a listing of product names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm489329.htm The following drugs had modifications to the CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections: Atacand (candesartan cilexetil) Tablets Atacand HCT (candesartan cilexetil/hydrochlorothiazide) Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets Avalide (irbesartan/hydrochlorothiazide) Tablets Cimzia (certolizumab pegol) Lyophilized Powder and Solution for Subcutaneous Use Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablets Depacon (valproate sodium) Injection Depakene (valproic acid) Capsules Depakene (valproic acid) Oral Solution Depakote (divalproex sodium) Delayed Release Tablets Depakote ER (divalproex sodium) Extended Release Tablets Depakote Sprinkle Capsules Fluorescite (fluorescein injection) Fosrenol (lanthanum carbonate) Chewable Tablets and Oral Powder Gilenya (fingolimod) Capsules Invirase (saquinavir mesylate) Capsules and Tablets Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) Tablets Tecfidera (dimethyl fumarate) Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets Vistaril (hydroxyzine pamoate) Capsules and Oral Suspension Complete and submit the report Online: http://www.fda.gov/MedWatch/report. Download form or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178  

Read More →

FDA Statement: Eye Drops-Potential Risk

FDA MedWatch – Eye Drops: FDA Statement – Potential Risk of Loose Safety Seals 03/15/2016 Eye Drops: FDA Statement – Potential Risk of Loose Safety Seals AUDIENCE: Consumer, Eye Care ISSUE: FDA is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used. See Safety Statement for example photo. FDA has received reports of six adverse events associated with loose safety seals on eye drop bottles. FDA is in the process of identifying all relevant products and will require a change in the packaging design. BACKGROUND: The plastic safety seal or tamper-evident ring, also known as a collar, or band, should stay connected to the bottle neck. However, some eye drop bottles are losing the safety seals or rings when consumers tilt or squeeze the bottle to place eye drops into their eyes. A loose safety seal or ring presents a safety risk as it may cause eye injuries. RECOMMENDATION: Consumers and health care providers who have these products should not attempt to remove the ring or seal because there is a potential to contaminate the tip of the dropper. FDA strongly recommends when using tamper-evident rings, the bottle/cap design include a positive-retention mechanism similar to those on disposable plastic beverage bottles to prevent the rings from coming off while using the product. FDA is continuing to investigate […]

Read More →

We Must Partner With Doctor's In Managing Our Illness & Prescriptions

Face to Face time with doctors is shrinking as payments from insurance companies are further reduced. No longer are the Patient Consumer Information pamphlets included with prescriptions from manufactures, they cost money. The medication information we receive from pharmacies is a cover your ass view of a few possible side effects. Doctors work on reduced rates leaving no choice but see more patients. I believe we are due the information to manage out health properly. What do I mean by managing our health properly? We have to take responsibility to gather information the doctor doesn’t have time to give. If lucky doctors allow 15 minutes per patient. How much information can you get in that amount of time. Especially if its a new or complex illness. We are our best advocates, we have to hold doctors accountable for the information we need. It is our responsibility to understand our illnesses and medications. Doctors do not have all the answers. You have to clarify communication, don’t get caught up in “it’s the doctor’s responsibility”, wrong. Two people are in the equation and you’re the sick one. These steps may help the journey to survival and beyond. Critical to getting well is seeing the right type of doctor. A medical doctor is not a mental health specialist, has no business dispensing  RX’s. Get a referral , if not you’re a trail and error for what they think will work. Not always in you best interest. […]

Read More →