b. Should the Agency has taken any actions in previous years (such as restricted distribution, withdrawal of product, or Dear Doctor letter) that they did not? Why or why not? As per my opinion, after reading these articles, it is very complicated to decide whether the FDA should has taken any actions against Pradaxa and its distribution. Studies held by FDA recently and in 2012, both conclude that “Pradaxa has favorable benefit to risk profile and does not require changes to the current label or recommendations for use. Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and …show more content…
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events. (2011, December 7). Retrieved September 27, 2014, from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm 3. FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin. (2014, May 13). Retrieved September 26, 2014, from http://www.fda.gov/Drugs/DrugSafety/ucm396470.htm 4. Silverman, E. (2012, November 6). Was The FDA Safety Analysis For A Popular Bloodthinner Flawed? Retrieved from http://www.forbes.com/sites/edsilverman/2012/11/06/was-the-fda-safety-analysis-for-a-popular-bloodthinner-flawed/ 5. Stiles, S. (2013, November 18). GI Bleeding on Dabigatran: Controversy Pits Meta-analysis vs Real-World Data. Retrieved from https://nuonline.neu.edu/bbcswebdav/pid-7729634-dt-content-rid-9953264_1/courses/RGA6212.71485.201515/Medscape%20article.pdf 6. Postmarketing Surveillance Programs. (n.d.). Retrieved September 27, 2014, from
U.S. Food and Drug Administration. (2014, April 16). Summary Basis for Regulatory Action - ALPROLIX. Retrieved May 19, 2014, from ALPROLIX: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm393432.htm
(15)Patel M, Mahaffey K, Garg J, Pan G, Singer D, Hacke W, Breithardt G, Halperin J, Hankey G, Piccini J, Becker R, Nessel C, Paolini J, Berkowitz S, Fox K.. (2011). Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.. New England Journal Of Medicine. 365 (10), 883-91.
and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicinemedical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Some of the committee's recommendations have been incorporated into drafts of the PDUFA IV bill, which was signed into law in 2007.
Nelson BSN, RN, Roxanne. "Controversay Surrounds Gardasil." AJN, American Journal of Nursing 108.7 (2008): 17. Print.
Lucian L. Leape Conducted a study in 1995 on “health policy analyst at the Harvard School of Public Health, found that 6.5 percent of patients at two teaching hospitals in Boston had been injured by their medicines, and one-third of these cases involved mistakes” (Stolberg, 1999). Due to this Study the F.D.A. official were convinced that the danger of prescription cascade is growing which prompted them to release a 150-page report which was made public, that called for pharmacists, doctors, hospitals and drug companies to work together to create ' 'a new framework ' ' for cutting down on overlapping prescription that have a high risk of causing a cascade. Explicit warning pamphlets were also created according to the new guidelines which requires manufacturers to release side effect possibilities in high risk drugs. (Stolberg, 1999)
Which in turn increases the uptake catabolism of serum LDL into the liver, resulting in decreased serum cholesterol levels. This reduction in serum LDL and cholesterol levels has resulted in a 10-year reduction in CHD and stroke risk. Pitavastatin was approved in Japan in 2003 and was granted FDA approval in 2009 and is marketed under the name of Livalo. Several phase III and IV trials have shown that Pitavastatin is both safe and efficacious in lowering both serum LDL and Triglycerides (TG) by 29.1% and 22.7% respectively from baseline levels, which was significant. These studies showed that only 10% of Pitavastatin treated patients had adverse events (AE) in which 84% of these events were mild and about 1% were serious adverse events (SAE)6, 12, 14, 16-26, 28-31.
...ing a wide variety of side effects ranging from nausea to severe psychological dependence. The large number of prescriptions being filled has led to an increased circulation of the drug. This, in turn, leads to a greater possibility of misuse of the drug. Office staff and administrators have to come up with safety procedure to insure safe and proper dispension of the drug.
Bowers, L., Allan, T., Simpson, A., Nijman, H., & Warren, J. (2007). Adverse Incidents, Patient
Recommendations are made by the FDA on bioequivalence using ratings. If the FDA rates a generic with an “A”, this means the generic and brand-name drug are interchangeable. A “B” rating translates to not recommending a substitution with the generic drug (Barrett, 2010). In a recent review by the FDA in more than 270 generic drugs, the average difference between the generic and brand-name counterpart was 3.5%. This percentage is very similar to what is expected and found between batches of brand-name drugs (Food and Drug Administration, 2012).
Chemotherapy drugs are more dangerous than other drugs because of their narrow therapeutic index. What is therapeutic index you ask? It is the ratio between a toxic dose and a therapeutic dose of a drug so any medication error with chemotherapy drugs could be a fatal one. Chemotherapy drugs can be very toxic even at the prescribed therapeutic level recommended by the physician. The findings in this article shows that the patient themselves are the first line of defense in spotting errors in medications they receive because they obs...
More research should be done on new oral anticoagulants with different study population and similar patients that are seen in everyday clinical practice as well as attempt to define the best pharmacodynamic monitoring tools. Research should be conducted to outline monitoring protocol including timing relative to dosing and frequency as well as therapeutic targets. Using these strategies, future trials could enhance further the efficacy and safety of these new agents and could extend their use to new indications.
Adverse drug events or medication errors that result from polypharmacy can often be difficult to predict and prevent. According to an article posted in the American Journal of Health-System Pharmacy (2012), drug –drug interactions may lead to increased toxicity levels when taken together. An example is the interactio...
In 2010 alone, three drugs reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) have failed to gain approval. EMDAC felt each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had unacceptable safety issues (particularly cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide enough convincing evidence of efficacy and safety to gain approval. EMDAC cite lack of diversity in the phase 3 trial population might result in efficacy of the drug being overstated while potential safety risks understated. Whi...
The Sensory integration frame of reference (FOR) has been used in occupational therapy treatment to treat individuals with Asperger’s syndrome ((Pfeiffer, Koenig, Kinnealey, Sheppard, & Henderson, 2011). Children with sensory processing deficits have difficulty regulating responses to sensations and stimuli (Pfeiffer et al., 2011). Therefore, the sensory integration FOR is designed to provide controlled sensory experiences so that an adaptive motor response is elicited (Pfeiffer et al., 2011). Interventions based on this FOR use planned, controlled sensory input in addition to the needs of the child and are characterized by an emphasis on sensory stimulation and active participation of the client (Pfeiffer et al., 2011). The objective of sensory integration is to improve sensory related behavior and attention and to increase abilities for children to interact socially, academically, and function independently (Pfeiffer et al., 2011). According to Pfeiffer et al. (2011), studies support the use of sensory integration interventions in children with Asperger’s syndrome.
The aims of the post-marketing safety surveillances program are to examine and quantify new drug safety issues, to recognize risk factors of product marketing, and to control medication use patterns (3). If undesirable effects are noticed In this forth phase of trial, the drug might get withdrawn from the market.