Senin, 01 Mei 2017

drugs for osteoporosis side effects

drugs for osteoporosis side effects

bjbjlulu judy woodruff: next, new cautionsare raised over drugs to help your bones. margaret warner has our story. margaret warner:millions of women as they age grapple with whether to take bone-density-building drugsto treat or prevent osteoporosis. this week, the food and drug administration in an articlein "the new england journal of medicine" urged caution about long-term use of so-called bisphosphonates,like fosamax, boniva, and actonel. long-term use has been linked to rare fractures andside-effects. osteoporosis afflicts some eight million women and two million men in the u.s.,and another 34 million have reduced bone mass that raises their risk for the disease. thefda analysis, drawing on two earlier industry-funded studies, found many of these women derivelittle or no benefit from the drugs after

three to five years. for more, we turn todr. clifford rosen, director of clinical research at maine medical center's research institute,and a professor at tufts university medical school. he co-wrote the article accompanyingthe fda study. and, dr. rosen, thanks for being with us. there's been. . . dr. cliffordrosen, maine medical center research institute: thank you for having me, margaret. margaretwarner: there's been an ongoing debate about these drugs. what new -- what is new herein this analysis that the fda has just provided? dr. clifford rosen: well, i think what theydid is, they asked the question, are these drugs continually being beneficial if they'readministered over a long period of time? we know that the drugs work over three to fiveyears. and the question they were asking is,

are they still effective if you continue totake them? there's really been no statement or no data on what -- how long individualsshould take these drugs. and with some side effects being reported with increasing frequency,still rare, but there are some side effects, the fda decided to go back and look very carefullyat all the trials that were conducted that looked at long-term treatment, that is, morethan three to five years. margaret warner: and who is taking these drugs and how widelyis it -- are they prescribed? dr. clifford rosen: so -- right. so, that's been the problem.we -- when these drugs came out -- they're great drugs. they reduce fracture risks. theyprotect individuals against osteoporosis. we initially thought that we should give themfor a lifetime, and nobody was really clear,

should there be a stop time? should therebe -- should they come off and then go back on? and as people started taking them forup to 15 years now, since the first drug was approved, there were these occurrences ofside effects. and i think every one of us got concerned and asked, what is the optimalduration of treatment? and i think this is where the investigation began. margaret warner:and when you say side effects, what are you talking about, the serious ones? dr. cliffordrosen: so, interestingly enough, there were very rare side effects where the jaw -- therewas problem with the jaw with infection. but, then, over the last five years, there havebeen reports of fractures actually occurring in women who have been taking long-term therapywith these drugs, which we call the bisphosphonates.

and it was this, i think, that alarmed bothregulators and investigators and clinicians to go back and look at the long-term studies.margaret warner: explain, if you would, how these drugs work when they're -- when they'reworking right in the early going. dr. clifford rosen: right. so they're very effective inthe early going. and what they do is, they block the body's ability to dissolve the bone.every 10 years, we get a new skeleton. it's surprising and we don't notice it, but weget a new skeleton. and part of that process is the repair process. first, the bone isdigested, and then it's repaired. if the digestion is too great, then there's bone loss. andwhat these drugs do, where they're very effective, it's stopping this bone -- what we call bonereabsorption, or dissolution of bone. so they

build bone density by keeping the bone thatyou already have and actually enhancing it. so the theory is great. and they actuallywork for the first three to five years. margaret warner: so if they do increase the densityof your bones, what is it about them that then would make after five years, you're actuallyat -- at least some people are at greater risk for a serious fracture? dr. cliffordrosen: right. so we don't think that there's a greater risk of fracture, but we don't thinkthere's any additional benefit. so for reasons we really don't understand, we know that thedensity will continue to increase, but when you look at rate of fractures, that beginsto plateau. so the protection, which was 50 percent to 70 percent reduction in fracturesthat we saw in the first three to five years,

then gradually disappears, even though thebone density is going up. so that means there's probably other factors going on. so what thefda found was that, if you continue the drugs beyond five years, there's no additional, we don't know the true risk of these rare side effects. and that's one of the issuesthat has to be resolved. but the fact that there's no continued benefit made them comeout with these findings and review all the data that was available. margaret warner:so what's the takeaway message for women who may have -- who have been told they eitherhave osteoporosis or they're in that broader category -- i think it's called osteopenia-- where they have some bone density loss? dr. clifford rosen: right. right. margaretwarner: what should they do? dr. clifford

rosen: so i think the bottom-line messageis, if you have very low bone density and/or you have had a fracture of your spine andyour bone density is very low, you are still at very high risk of fracture. those individuals-- and we tried to point that out in our article -- those individuals should be maintainedon the current drugs we have. but if your bone density has gotten a lot better, or ifyou're in that osteopenic range, we found -- and the fda did as well -- that continuingtherapy is not necessarily needed, because the drugs stay in the system for a fair amountof time, and there's no additional protection. margaret warner: well, dr. clifford rosen,thank you so much. urn:schemas-microsoft-com:office:smarttags placetype urn:schemas-microsoft-com:office:smarttagsplacename urn:schemas-microsoft-com:office:smarttags

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