Fwd: FDA Data: Drug Injury / Deaths Spiral: Chantix Worst Safety Record

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIA just released analysis of adverse drug event data reported to the FDA inthe first three months of 2008 documents a prescription drug-induceddisaster-and an agency that has done nothing to protect the public fromhazardous drugs.The report by The Institute for Safe Medication Practices,*http://www.ismp.org/quarterwatch/2008q1.pdffound that in the first quarter of 2008, the FDA received 20,745 reportsdocumenting serious injury from prescribed drugs. This represents a 34%increase from the 15, 411 cases reported in the previous quarter, and a 38%increase when compared to the average over the previous four quarters.The death toll reported to the FDA during 3 months reached 4,824 deathscompared with 1,868 deaths in the previous quarter. This 2.6 fold increaseis the highest number of drug-related deaths yet reported in a calendarquarter. Of note: FDA's sources for data about serious adverse drug events comemostly from manufacturers (82%) and only a small percentage (18%) fromdoctors and consumers. Because reporting is voluntary, only a small fractionof adverse drug events that occur are ever reported to the FDA.  Every drugsafety expert agrees that the number of serious injuries and deaths are muchhigher than those reported to the FDA.One drug, in particular, stands out for the sheer magnitude of its hazards. For a second straight quarter, "varenicline (Chantix, Champix), an aid tostopping smoking, accounted for more reported serious injuries than anyother prescription drug--a total of 1,001 new cases, including 50 additionaldeaths."Indisputable Facts FDA's "accelerated" ("fast-track") drug approval process has had adevastating effect on consumer safety.Chantix is a case in point. It was approved in 2006 under FDA's fast-trackreviewing process-even though it does not treat a life-threatening diseasefor which no other treatment is available. Indeed, Chantix is used mostly by healthy people trying to quit smoking. FACTS known to FDA officials:* The FDA received more reports about serious injuries and adverse eventsinvolving Chantix than any other drug on the market.* Chantix garnered MORE reports of SERIOUS INJURIES than the top 10 mostfrequently prescribed brand name drugs COMBINED. Since its fast-track approval (May 2006) the FDA received 3,325 reportslinking Chantix to  serious injuries, including 112 deaths.  * There are safe alternatives to help people stop smoking without thehazards posed by Chantix-for example, nicotine chewing gum, nicotinelozenges, acupuncture.Chantix has been linked to numerous cases of serious injury in trafficaccidents and falls.Other reports describe events such as blackout which have a high potentialto cause accidents. The scope and magnitude of the serious--life-threatening hazards to self andothers posed by Chantix (manufactured by Pfizer), initially documented in areport issued by ISMP in May 21, 2008,http://www.ismp.org/docs/vareniclineStudy.asp bear a startling resemblanceto the hazards posed by the controversial neuroleptics/ antipsychotics.   *From its "fast-track"  review and approval in May 2006 through December2007, the FDA had received the following serious adverse reports aboutChantix: 227 domestic reports of suicidal acts, thoughts or behaviors; 397 cases of possible psychosis and 525 reports of hostility oraggression--including 28 cases of suicide and 41 mentions of homicidal ideation; 60 cases of paranoia and 55 cases of hallucination. * Accidents and injuries. A total of 173 serious events described accidentalinjury-- including 28 road traffic accidents and 77 falls, some leading to fracturesof rib, facial bones, hand, ankle, spine, and lower limbs. In these cases a variety of potential causes were identified, including lossof consciousness, mental confusion, dizziness and muscle spasms.* Vision disturbance potentially leading to accidents and injuries. At least 148 reports vision disturbances--including 68 cases described asblurred vision and 26 terms indicating transient or other forms of blindness. * Heart rhythm disturbances:  224 domestic reports classified as potentialcardiac rhythm disturbances dominated by reports of sudden loss ofconsciousness.* Seizures and abnormal muscle spasms or movements:  including 86 cases ofconvulsions (seizures); 372 reports of a wide variety of movement disorders--indicating braindamage--including tremors, muscle spasms, twitching, tics, drooling, andmotor hyperactivity. * Moderate and severe skin reactions: including 338 cases of hives orswelling of the tongue, face, eyes, lips or other areas. additionally, 65 cases classified as severe--included blisters, exfoliationof the skin and lips, and Stevens-Johnson Syndrome.* Diabetes. The FDA has received 544 reports linking Chantix to a loss ofglycemic control and reports identified numerous cases of new onset diabetesdocumented by symptoms and laboratory tests.Following the ISMP report (May 21), several federal agencies took promptaction to ban Chantix in sensitive occupations such as for airline pilotsand military missile crews.  FDA officials, by contrast, are still gambling with the lives of theAmerican public.  The FDA has failed to withdraw the drug until its manufacturer can provideevidence demonstrating it to be safe.The FDA has not even issued black box warnings about this drug's documentedlethal risks--risks which pose a danger to self and others.Instead, FDA's inadequate warning label blurs the danger posed by the drugby suggesting "nicotine withdrawal" may be the cause:  "Serious neuropsychiatric symptoms have occurred in patients being treatedwith CHANTIX. Some cases may have been complicated by the symptoms ofnicotine withdrawal in patients who stopped smoking; however, some of thesesymptoms have occurred in patients who continued to smoke. All patientsbeing treated with CHANTIX should be observed for neuropsychiatric symptomsincluding changes in behavior, agitation, depressed mood, suicidal ideationand suicidal behavior."http://www.fda.gov/cder/foi/label/2008/021928s008lbl.pdfFDA's failure to take action to protect patients, no doubt, encouragedPfizer to launch a direct-to-consumer national advertising campaign in thecountry's five largest newspapers, as well as television commercials,conferences with reporters, and letters to 300,000 health-care providers. FDA officials sit idly by as the most dangerous, psychosis-inducing drug ispromoted to increase sales. FDA officials should be held accountable-no lessthan Pfizer officials-for failing to use their authority to restrict the useof a drug that poses increased danger both to those who ingest Chantix andto others who may become casualties on America's highways.The authors of this ISMP report, Thomas J. Moore, Senior Scientist, DrugSafety and Policy, ISMP; Michael R. Cohen RPh, MS, ScD, President, ISMP;Curt D. Furberg, MD, PhD, Professor of Public Health Sciences, Wake ForestUniversity School of Medicine; state."We believe, for example, that when varenicline [Chantix] accounted for morereported injuries than any other drug in medical use, this was in itself asignal of a problem requiring additional investigation. Also, 100 deathsattributed to one drug in one calendar quarter is a noteworthy toll, evenwithout adjustment for under reporting. In the United States, 100 deaths islarger than the toll of almost any hurricane, flood, expressway pileup andwould exceed the average annual deaths from aircraft crashes. Put anotherway, the 4824 deaths reported in the first quarter of 2008 would exceed thetotal number of homicide victims in the same period, except that it ishighly unlikely that all the drug-related deaths were reported."On Nov. 3, the Supreme Court justices will be considering whether FDAapproval preempts state consumer safety laws--effectively shielding drugmanufacturers from liability for marketing defective, harm-producing drugs.The preemption argument rests on the mistaken premise that the FDA is areliable agency for ensuring that drugs it approved for marketing have beenscientifically proven safe. The justices cannot ignore the indisputableevidence: the death toll from FDA approved marketed drugs is spiraling.FDA's failure to exercise due diligence in its approval process-or towithdraw drugs whose hazards emerge after they are marketed, or even toissue warnings about such hazards--disqualifies the agency as the solearbiter of drug safety. *The Institute for Safe Medication Practices is an independent, non-profitorganization promoting patient safety and reduction of medication errors.Contact: Vera Hassner Sharavveracare212-595-8974_____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.