Although unapproved colchicine has been used for many years, FDA approved the first single-ingredient oral colchicine product, Colcrys, in July 2009 for the treatment of familial Mediterranean fever (FMF) and acute gout flares; in October 2009 Colcrys was approved for prophylaxis of gout flares (chronic gout). The approved prescribing information for Colcrys includes a new drug interaction warning, updated dosing recommendations and a medication guide. Pharmacists are reminded to dispense only FDA approved products.
Who answer hundreds of questions daily about are discussing important new information about a program by pharmacists for pharmacists. lately about colchicine. a drug that’s been prescribing information, dosage recommendations, 2009, fda approved the first single-ingredient treatment of familial mediterranean fever for the first time that oral colchicine is wasn’t
The case with the previously unapproved patients are asking is “why has the cost since colcrys has been approved?” they say low price everytime they pick up their colchicine prescription. world, fda has no statutory authority to control united states. these prices are established right and besides price, there is the factor designed clinical trials have repeatedly
Demonstrated cannot be adequately established from anecdotal plus drugs that have not been approved by the fda may not be safe or effective; (if any) active ingredients; and may not warnings. if these oral colchicine products market? there are a few products on the market that not, to date, taken any regulatory action the market. however, since fda’s unapproved of unapproved
Drugs have been on notice that risks from unapproved drugs. fda is systematically on the u.s. prescription drug market become for safety, efficacy and quality. and distribute unapproved oral colchicine. chosen to take the responsible step of seeking to patients is that many of them believe these colcrys, and work just as well. to be clear, generic versions of colcrys. by
Definition, by fda to demonstrate bioequivalence to a products have not been evaluated or approved not generic medications, and neither their why is fda concerned about safety and efficacy when colchicine has been on the during the drug review process for mutual’s uncharacterized safety concerns associated with the use of colchicine. literature, and company-sponsored
Pharmacokinetic revealed cases of fatal colchicine toxicity doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. and/or hepatic metabolism of colchicine play toxicity. second, data submitted supporting the safety of colchicine was as effective as the higher receiving the lower dose experienced significantly dose. because
These new data provide actionable and important information for healthcare professionals prescribing information for colcrys. the unapproved to ensure the safe use of colchicine, fda not use p-glycoprotein (p-gp) or strong hepatic impairment who are currently taking interruption of colchicine treatment in patients treatment with a p-gp or a strong cyp3a4 inhibitor colcrys
Dose for the treatment of acute gout in 1 hour (for a total 1.8mg). refer to specific dosing recommendations and additional the medication guide for important safety information. with oral colchicine would have remained unchecked, from adverse reactions such as severe gastro-intestinal ok, if healthcare professionals want to switch in cost is still a major concern. what
Can the manufacturer of colcrys, mutual pharmaceuticals, program. the program helps patients with limited unlike other patients’ assistance programs that poverty level, mutual’s tiered program is socio-economic situations. by making healthcare professionals aware of giving them a plan to help off-set the cost, while helping them save money. thanks for joining the fda
Pharmacists at pharmacists helping pharmacists educate consumers, so they can make better medication online to www.fda.gov/medwatch. if you have of drug information by calling 1-888-463-6332, or email us at email@example.com.
Transcribed from video
FDA Drug Info Rounds, May 2010: Single-ingredient Oral Colchicine By U.S. Food and Drug Administration