{"id":28611,"date":"2012-10-08T17:57:36","date_gmt":"2012-10-08T21:57:36","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=28611"},"modified":"2012-10-08T17:57:36","modified_gmt":"2012-10-08T21:57:36","slug":"no-surprise","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/10\/08\/no-surprise\/","title":{"rendered":"no surprise…"},"content":{"rendered":"
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Just Like That? Trying To Discontinue Cymbalta<\/font><\/u><\/a><\/strong>
Pharmalot<\/font><\/strong>
By Ed Silverman
October 8th, 2012<\/div>\n

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There has always been concern about discontinuing antidepressants and withdrawal symptoms. But a new analysis finds that anywhere from 44 percent to 50 percent of Cymbalta patients experienced withdrawal symptoms after clinical trials, and more than half were resolved within two weeks. Moreover, there was a “serious breakdown” at both the FDA and Eli Lilly in providing adequate warnings and instructions. The analysis was conducted after the Institute for Safe Medicine Practices<\/font><\/u>, after reviewing adverse events reported to in the first quarter of 2012 and found 48 case reports of drug withdrawal for Cymbalta. These included blackouts, suicidal thoughts, tremor, and nausea, and several cases involved hospitalization. This contrasted with an FDA safety review conducted in 2001 for the Cymbalta new drug application.<\/p>\n

“It appears that symptoms are relatively mild and reliably predictable for a significant minority of patients. Tapering duloxetine at discontinuation appears to be advisable for optimal patient comfort, but not tapering does not appear to pose any serious risk,” the FDA wrote, according to ISMP, which cites the 2001 document [here is the ISMP report<\/font><\/u><\/a>]. Meanwhile, Lilly studied withdrawal effects in nine early clinical trials for depression. “As the trials reached the end of the treatment at eight or nine weeks, patients were switched to an inactive placebo and then monitored for an additional one or two weeks. Patients who volunteered new symptoms or more severe symptoms were counted as experiencing withdrawal effects,” ISMP writes in its analysis.<\/p>\n

Lilly, subsequently, reported symptoms in 44 percent of patients who discontinuing Cymbalta after nine weeks or less, and 50 percent in longer trials. “About 10 percent of withdrawal symptoms in short-term trials were rated as severe and nearly 54 percent had not resolved after up to two weeks. What happened to these patients after two weeks is unknown. The outcomes of severe and persistent cases remain poorly studied,” ISMP writes…<\/p>\n

The upshot: ISMP concludes by writing that “a major lapse has occurred in the FDA-approved information for patients about the risks of stopping duloxetine. The information for prescribing physicians is somewhat better, but still inadequate about counseling patients; instructions for an adequate taper regime are omitted entirely. Furthermore, a major gap exists in our scientific understanding of the incidence and management of withdrawal syndrome cases that are severe and persistent.”<\/strong><\/sup><\/div>\n<\/blockquote>\n

No big surprise here, I guess. If it’s a psychoactive drug, there is likely to be a withdrawal syndrome [all the more difficult when there’s a capsule involved]. Since I’ve never prescribed a drug with a television personality, I didn’t know about this one. I guess this will get rolled into the mumble that follows the shiny ‘pain relief’ ads.<\/div>\n","protected":false},"excerpt":{"rendered":"

Just Like That? Trying To Discontinue Cymbalta Pharmalot By Ed Silverman October 8th, 2012 There has always been concern about discontinuing antidepressants and withdrawal symptoms. But a new analysis finds that anywhere from 44 percent to 50 percent of Cymbalta patients experienced withdrawal symptoms after clinical trials, and more than half were resolved within two […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-28611","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/28611","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=28611"}],"version-history":[{"count":8,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/28611\/revisions"}],"predecessor-version":[{"id":28619,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/28611\/revisions\/28619"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=28611"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=28611"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=28611"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}