{"id":97974,"date":"2009-12-22T13:58:18","date_gmt":"2009-12-22T18:58:18","guid":{"rendered":"http:\/\/blogs.wsj.com\/health\/2009\/12\/22\/vytorin-update-cancer-risk-generic-challenge\/"},"modified":"2009-12-22T13:58:18","modified_gmt":"2009-12-22T18:58:18","slug":"vytorin-update-cancer-risk-generic-challenge","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/97974","title":{"rendered":"Vytorin Update: Cancer Risk, Generic Challenge"},"content":{"rendered":"

\"Vytorin\"A couple pieces of news today on Merck’s big cholesterol drug Vytorin, which has seen its share of trouble<\/a> in the past couple years but remains widely prescribed<\/a>:<\/p>\n

The FDA said<\/a> it’s “unlikely” that Vytorin or Zetia, another<\/strong> Merck drug, increase the risk of cancer. But “an association cannot be definitively ruled out,” the agency said. Vytorin is a combination of two drugs — Zetia and a statin called simvastatin. It’s clear that simvastatin doesn’t raise cancer risk, the FDA said, but there’s not enough data to “definitively rule out” a cancer link for Zetia (known generically as ezetimibe).<\/p>\n

The uncertainty comes from a study<\/a> that found there were more cancers and cancer-related deaths in patients who took Vytorin, compared with those who received placebo. But other studies of the drug have not shown similar risk. Animal studies have not shown a cancer link. And the cancer risk found in the study came from combining several types of cancer together. “It is biologically less likely that a single drug increases the risk of a wide variety of cancer types,” the FDA said.<\/p>\n

Mylan, a big generics shop, said<\/a> it had been sued by a Merck subsidiary<\/strong> for patent infringement because it applied to sell a generic version of Vytorin. <\/p>\n

This is is the kind of lawsuit generic drug makers wear like a badge of honor these days. In its statement today, Mylan said it believes it is the first generic company to file this sort of application for Vytorin; if the company is correct, it will get a six-month window during which it’s the only generics company allowed to compete against Merck for sales of the drug. <\/p>\n

An exclusivity period on a big drug like Vytorin — and it’s still a very big drug, despite the troubles it’s had — means a windfall for a company like Mylan.<\/p>\n

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A couple pieces of news today on Merck’s big cholesterol drug Vytorin, which has seen its share of trouble in the past couple years but remains widely prescribed: The FDA said it’s “unlikely” that Vytorin or Zetia, another Merck drug, increase the risk of cancer. But “an association cannot be definitively ruled out,” the agency […]<\/p>\n","protected":false},"author":650,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-97974","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/97974","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/650"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=97974"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/97974\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=97974"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=97974"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=97974"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}