FDA: Lit­tle ev­i­dence to support testos­terone drugs

The Times Herald (Norristown, PA) - - HEALTH - By MATTHEW PER­RONE

WASH­ING­TON— The Food and Drug Ad­min­is­tra­tion says there is lit­tle ev­i­dence that testos­terone-boost­ing drugs taken by mil­lions of Amer­i­can men are ben­e­fi­cial, though the agency is also un­con­vinced by stud­ies sug­gest­ing the hor­mone car­ries se­ri­ous risks.

The agency posted its re­view on­line Wed­nes­day ahead of a pub­lic meet­ing to dis­cuss the ben­e­fits and risks of treat­ments that raise lev­els of the male hor­mone. Reg­u­la­tors agreed to con­vene the Septem­ber 17 meet­ing after two fed­er­ally funded stud­ies found links be­tween testos­terone ther­apy and heart prob­lems in men.

The scru­tiny comes amid an in­dus­try mar­ket­ing blitz for new pills, patches and for­mu­la­tions that has trans­formed testos­terone a multi­bil­lion-dol­lar mar­ket. Ad­ver­tise­ments for pre­scrip­tion gels like Fortesta and An­dro­gel prom­ise ag­ing men re­lief from “Low-T,” a con­di­tion they link to low libido, fa­tigue and weight gain.

But FDA re­view­ers state that “the need to re­place testos­terone in th­ese older men re­mains de­bat­able.” While testos­terone lev­els nat­u­rally de­cline after age 40, it’s un­clear whether those lower lev­els ac­tu­ally lead to the signs com­monly as­so­ci­ated with ag­ing, in­clud­ing de­creased en­ergy and loss of mus­cle.

The FDA first ap­proved testos­terone in­jec­tions in the 1950s for men who had been di­ag­nosed with hy­pog­o­nadism, a form of ab­nor­mally low testos­terone caused by in­jury or med­i­cal ill­ness.

But the re­cent ad­ver­tis­ing push is fo­cused on oth­er­wise healthy men who sim­ply have lower-than-nor­mal lev­els of testos­terone.

The FDA memo calls testos­terone use in th­ese pa­tients “con­tro­ver­sial” and notes that “there are no re­li­able data on the ben­e­fit in such a pop­u­la­tion.”

The agency will ask its panel of out­side ex­perts this month whether the pre­scrib­ing in­for­ma­tion on testos­terone drugs should be re­vised to fo­cus on a nar­rower group of pa­tients.

The pan­elists will also be asked to weigh in on two re­cent stud­ies that showed higher rates of car­dio­vas­cu­lar prob­lems in men us­ing testos­terone. A U.S. Vet­er­ans Af­fairs study pub­lished in Novem­ber 2013 showed a 30 per­cent in­crease in stroke, heart at­tack and death among older men tak­ing testos­terone. In Jan­uary, another fed­er­ally funded study of 45,000 men with an ex­ist­ing heart con­di­tion sug­gested testos­terone ther­apy could dou­ble the risk of heart at­tacks in men 65 and older.

But in its re­view, the FDA notes that two other stud­ies have as­so­ci­ated testos­terone with longevity. Ac­cord­ing to the agency re­view, the avail­able stud­ies “do not pro­vide con­vinc­ing ev­i­dence that testos­terone re­place­ment ther­apy is as­so­ci­ated with ad­verse car­dio­vas­cu­lar events.”

Ac­cord­ing to the re­view doc­u­ments, FDA will ask its ex­perts whether drug­mak­ers should be re­quired to con­duct long-term follow-up stud­ies to as­sess heart risks with testos­terone drugs.

Roughly 2.3 mil­lion U.S. pa­tients re­ceived a pre­scrip­tion for testos­terone last year, up 77 per­cent from 2010, ac­cord­ing to FDA fig­ures. The agency notes that more than 20 per­cent of pa­tients who re­ceived a pre­scrip­tion did not have any record that their testos­terone lev­els were mea­sured.

Con­sumer ad­vo­cacy group Pub­lic Cit­i­zen said the FDA’s re­view down­plays the ev­i­dence of heart risks shown across mul­ti­ple stud­ies. In Fe­bru­ary the group pe­ti­tioned the FDA to add a boxed warn- ing — the most se­ri­ous type — to all testos­terone drugs about po­ten­tial heart risks. Although the FDA re­jected that pro­posal, the group’s Dr. Sid­ney Wolfe says he still ex­pects the re­cent stud­ies about heart risks to be added to testos­terone’s la­bel.

“There will be a warn­ing and once it hap­pens the pre­scrib­ing will drop way down, and that will be to the bet­ter­ment of the pub­lic health in this coun­try,” said Wolfe, of Pub­lic Cit­i­zen’s health group.

Wolfe noted that pre­scrip­tions for An­dro­gel, the best-sell­ing testos­terone drug from Ab­bott Lab­o­ra­to­ries, have al­ready fallen 23 per­cent since July 2013.

In a sep­a­rate memo, 12 man­u­fac­tur­ers of testos­terone drugs ac­knowl­edged that there are no long-term stud­ies of testos­terone ther­apy, mak­ing it dif­fi­cult to gauge their ben­e­fits and risks. Still the com­pa­nies pledged to ed­u­cate doc­tors and pa­tients about the drugs “so that they can make in­formed treat­ment de­ci­sions.”

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