Well­ness Arti­cles

Adverse Drug Reac­tions Rise Sharply — Study Says

The above head­line comes from the Sep­tem­ber 10, 2007 LA Times and is one of many arti­cles report­ing on a study pub­lished on the same day in the Archives of Inter­nal Med­i­cine. The study data came from the Adverse Event Report­ing Sys­tem, which has been in oper­a­tion since 1998. This sys­tem col­lects all vol­un­tary reports of adverse drug events sub­mit­ted directly to the US Food and Drug Admin­is­tra­tion (FDA) or through drug manufacturers.

The results of this study showed that from 1998 through 2005 reported, seri­ous adverse drug events increased 2.6-times from 34,966 to 89,842. In addi­tion, fatal adverse drug events increased 2.7-fold from 5519 to 15,107. The study noted that reported seri­ous events increased 4 times faster than the total num­ber of out­pa­tient pre­scrip­tions dur­ing the same period of time.

Thomas J. Moore, the study’s lead author and a senior sci­en­tist for drug safety and pol­icy at the Insti­tute for Safe Med­ica­tion Prac­tices of Hunt­ing­ton Val­ley, Penn­syl­va­nia, stated, “This is a direct set of data that shows that the sys­tem is fail­ing and it is get­ting worse. We are in denial about drug safety.” Moore con­tin­ued, “The clear find­ing is that we are los­ing ground in terms of drug safety, and that ought to be of great concern.”

Dr. Ger­ald Dal Pan, direc­tor of the FDA’s office of sur­veil­lance and epi­demi­ol­ogy tried to explain away the find­ing in a response in the LA Times when he said, “There are clearly other fac­tors respon­si­ble for this increase, such as the increase in pub­lic atten­tion to drug safety and use of the Inter­net to make it eas­ier for the pub­lic to report adverse events to the FDA.”

This report is bring­ing more polit­i­cal pres­sure from leg­is­la­tors for the FDA to take stronger action. Sen­a­tor Charles Grass­ley, of Iowa and an out­spo­ken FDA critic said in a state­ment, “This report is another indi­ca­tion that the FDA’s post-​market review of drugs must be rig­or­ous and timely. The FDA needs to com­mit itself to con­sid­er­ing and act­ing on the addi­tional data gath­ered from more adverse events being reported con­sid­er­ing the deaths asso­ci­ated with these adverse drug events.”

The con­clu­sion of the researchers in their study serves as a glar­ing reminder of the risks. They state, “These data show a marked increase in reported deaths and seri­ous injuries asso­ci­ated with drug ther­apy over the study period. The results high­light the impor­tance of this pub­lic health prob­lem and illus­trate the need for improved sys­tems to man­age the risks of pre­scrip­tion drugs.”

Ran­dom Article

birth traumaJeanne Ohm, DC

The effects, fre­quency and overt dam­age of birth trauma is per­haps the eas­i­est way to under­stand why all chil­dren need to be checked

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