{"id":5797,"date":"2016-02-19T12:41:00","date_gmt":"2016-02-19T12:41:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/dear-fda-daraprim-website-lacks\/"},"modified":"2019-02-21T01:15:13","modified_gmt":"2019-02-21T01:15:13","slug":"dear-fda-daraprim-website-lacks","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dear-fda-daraprim-website-lacks\/","title":{"rendered":"Dear FDA: The Daraprim Website Lacks Some Important Safety Information Patients Should Know About!"},"content":{"rendered":"\n\n\n\n
<\/a><\/td>\n<\/tr>\n
Click on image for an enlarged view.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

(This post was updated on 20-Feb-2016.)<\/p>\n

This morning, I was reading a story in MM&M about the testimony of Turing Pharmaceuticals chief commercial officer Nancy Retzlaff during a recent House hearing on drug pricing, where she attempted to justify the 5,000% price increase on the firm’s toxoplasmosis treatment Daraprim.<\/p>\n

Retzlaff “defended the dramatic hike in part by noting that the drugmaker provides access through patient assistance programs (PAPs)” (read “Turing Testimony Changes Perception of #Pharma Patient Assistance Programs<\/a>“).<\/p>\n

I decided to check out Turing’s PAP by visiting www.turingpharma.com where I clicked on the “PRODUCTS” tab, then “Daraprim.” I was taken to the page<\/a> shown on the left (http:\/\/www.daraprimdirect.com\/patients).<\/p>\n

Notice anything unusual?<\/p>\n

<\/a>The page does not include enough Important Safety Information (ISI), in my opinion. The only side effect mentioned is this:<\/p>\n

“DARAPRIM may cause folate deficiency which can lead to blood toxicity.” This is not very helpful for patients.<\/p>\n

I went to WebMD (here<\/a>) to read this important list of side effects that patients can recognize: <\/p>\n

“Tell your doctor right away if any of these symptoms occur: easy bruising\/bleeding, signs of serious infection (such as high fever, severe chills, persistent sore throat), signs of low red blood cell count (such as severe tiredness, pale lips\/nails\/skin, fast heartbeat\/breathing with usual activities), swollen\/painful tongue.”<\/p>\n

I am not sure this warrants a Warning Letter from the FDA, but I notified them via OPDP’s Bad Ad program. Time will tell. <\/p>\n","protected":false},"excerpt":{"rendered":"

Click on image for an enlarged view. (This post was updated on 20-Feb-2016.) This morning, I was reading a story in MM&M about the testimony of Turing Pharmaceuticals chief commercial officer Nancy Retzlaff during a recent House hearing on drug pricing, where she attempted to justify the 5,000% price increase on the firm’s toxoplasmosis treatment […]<\/p>\n","protected":false},"author":2,"featured_media":12108,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[293,104,44,294,247,295],"topic":[],"acf":[],"yoast_head":"\nDear FDA: The Daraprim Website Lacks Some Important Safety Information Patients Should Know About! - Pharma Marketing Network<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/dear-fda-daraprim-website-lacks\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dear FDA: The Daraprim Website Lacks Some Important Safety Information Patients Should Know About! - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Click on image for an enlarged view. (This post was updated on 20-Feb-2016.) 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