FDA to slash Avan­dia ac­cess

Heart risks prompt re­stric­tions on the di­a­betes drug, but some pa­tients may still be able to use it.

Los Angeles Times - - Front Page - Thomas H. Maugh II re­port­ing from los an­ge­les An­drew Za­jac re­port­ing from washington

The agency also halts a ma­jor study of the di­a­betes drug over con­cerns that it car­ries high car­dio­vas­cu­lar risks.

The Food and Drug Ad­min­is­tra­tion said Thurs­day that it would sharply limit ac­cess to the di­a­betes drug Avan­dia be­cause of con­cerns that it in­creases the risk of heart attacks and other car­dio­vas­cu­lar prob­lems.

Pa­tients who are now tak­ing the drug will have to sign an in­formed con­sent state­ment ac­knowl­edg­ing that they un­der­stand all the risks be­fore they will be al­lowed to re­fill their pre­scrip­tions.

New pa­tients will not be able to re­ceive the drug un­less their doc­tors cer­tify that they are un­able to con­trol their blood sugar lev­els with other ther­a­pies and that med­i­cal prob­lems pre­clude them from tak­ing Avan­dia’s pri­mary com­peti­tor, Ac­tos.

At the same time, the Euro­pean Medicines Agency said that it would sus­pend mar­ket­ing of Avan­dia through­out the Euro­pean Union.

Reg­u­la­tors in the EU don’t have the op­tion of re­quir­ing pa­tients to ac­knowl­edge a drug’s risk, so the sus­pen­sion was nec­es­sary.

Dr. Mar­garet A. Ham­burg, the FDA com­mis­sioner, said the two agen­cies had been in close con­sul­ta­tion re­gard­ing the drug, which is also known by the generic name rosigli­ta­zone.

“In our view, there is sub­stan­tial align­ment be­tween the agen­cies on the in­ter­pre­ta­tion and the risk to health,” Ham­burg said at a news con­fer­ence.

In both cases, the new rules will not take ef­fect for sev­eral months.

In the United States, about 600,000 di­a­betes pa­tients are re­ceiv­ing Avan­dia.

“We think the num­ber will go down very, very sig­nif­i­cantly with these new re­quire­ments,” Ham­burg said.

Dr. Ellen Strahlman, chief med­i­cal of­fi­cer for Glax­oSmithK­line, which makes the drug, said in a state­ment that the com­pany be­lieves Avan­dia “is a safe and ef­fec­tive treat­ment when used ap­pro­pri­ately,” but it will stop pro­mo­tion of the drug in all the coun­tries in which it op­er­ates.

Dr. Joshua Sharf­stein, the FDA’s prin­ci­pal deputy com­mis­sioner, said that “pa­tients should con­tinue tak­ing the med­i­ca­tion and con­sult their health­care provider.

“It’s very im­por­tant that pa­tients con­tinue to con­trol their blood sugar.”

The new rules will also ap­ply to com­bi­na­tion drugs made with rosigli­ta­zone, in­clud­ing Avan­damet, which con­tains met­formin, and Avandaryl, which con­tains glimepiride.

Con­cerns about Avan­dia’s safety also led the FDA to sus­pend a ma­jor clin­i­cal study, called TIDE, that di­rectly com­pares the ef­fi­cacy of Avan­dia and Ac­tos in con­trol­ling blood sugar.

Pa­tients with Type 2 di­a­betes lose their abil­ity to re­spond to in­sulin, which pre­vents them from con­vert­ing glu­cose into en­ergy. As a re­sult, it builds up in their blood, putting them at risk for heart dis­ease, vi­sion prob­lems and dam­age to nerves and blood ves­sels.

The Na­tional In­sti­tutes of Health es­ti­mates that 23.6 mil­lion Amer­i­cans have Type 2 di­a­betes. Avan­dia was hailed as a ma­jor im­prove­ment in di­a­betes con­trol when it was in­tro­duced in 1999. In 2006, at least 1mil­lion Amer­i­cans with Type 2 di­a­betes were tak­ing it.

But Avan­dia be­came the sub­ject of fierce de­bate when a Cleve­land Clinic car­di­ol­o­gist, Steven Nis­sen, pub­lished a study in 2007 sug­gest­ing that there was as much as a 40% in­crease in the risk of car­dio­vas­cu­lar dis­ease, heart at­tack, stroke and death among peo­ple us­ing the drug.

Sub­se­quent stud­ies gen­er­ally sup­ported his find­ings, and the drug came to be seen as a test of how an Obama ad­min­is­tra­tion FDA weighed risks and ben­e­fits in de­ter­min­ing the fate of high-pro­file phar­ma­ceu­ti­cals and the bil­lions of dol­lars in rev­enue that comes with them.

In 2007, the FDA put a so­called black box warn­ing on the drug’s la­bel alert­ing con­sumers to the risk, and sales be­gan fall­ing.

An FDA ad­vi­sory com­mit­tee re­vis­ited the is­sue in a heated meet­ing in July, where some ex­perts ar­gued for stronger warn­ing la­bels on Avan­dia and oth­ers called for its im­me­di­ate with­drawal.

Thurs­day’s rul­ings by the FDA and its Euro­pean coun­ter­part mean “the drug is ef­fec­tively gone from use,” Nis­sen said in an in­ter­view Thurs­day.

The re­stric­tion “is not go­ing to be a prob­lem for us as prac­ti­tion­ers” be­cause of the avail­abil­ity of Ac­tos and other treat­ment op­tions, said Dr. Mark Molitch, an en­docri­nol­o­gist at Chicago’s North­west­ern Me­mo­rial Hos­pi­tal.

Molitch said he grew wary of Avan­dia as the de­bate over it pro­gressed.

“I’ve never taken peo­ple off of it, but I have to con­fess I haven’t been putting new pa­tients on it,” he said.

Nis­sen lauded the curb­ing of Avan­dia, but he com­plained that “this took far too long” be­cause within the FDA, “the pro­mo­tion of drugs gets much more con­sid­er­a­tion than the re­stric­tion of drugs. That’s got to change.”

Ac­tos, made by Ja­pan-based Takeda Phar­ma­ceu­ti­cals, has not been as­so­ci­ated with car­dio­vas­cu­lar prob­lems,.

But last week the FDA an­nounced it was study­ing whether there is an in­creased risk of blad­der can­cer from tak­ing the drug.

Shares of Bri­tain-based Glax­oSmithK­line fell 72 cents, to $39.43, Tues­day on the New York Stock Ex­change. thomas.maugh @latimes.com aza­jac@latimes.com

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