FDA Reviewers: Fish Hormone Use May Be Linked To Cancer Risk.

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cp418
cp418 Member Posts: 7,079
edited June 2014 in Clinical Trials, Research News, Podcasts, and Study Results

FDA Reviewers: Fish Hormone Use May Be Linked To Cancer Risk.

In continuing coverage, MedPage Today (3/5, Gever) reports that during a joint panel hearing today, the FDA's Reproductive Health Drugs Advisory Committee and its Drug Safety and Risk Management Committee will "vote on whether existing and future calcitonin salmon products are effective and safe enough to be sold for osteoporosis fracture prevention in postmenopausal women." In a briefing document (pdf) released as background material for the meeting, FDA reviewers noted that a number of "products consisting of a 32-amino-acid fragment of the calcitonin salmon hormone are currently approved in the US," including Novartis' Miacalcin and Upsher-Smith Laboratories' Fortical, as well as "generic versions of a calcitonin salmon nasal spray." However, the briefing document also indicates data from "multiple clinical and preclinical studies," include one trial that "found a greater likelihood of prostate cancer in male patients receiving an oral form of calcitonin salmon," prompted the FDA to schedule the committee meeting.

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  • LtotheK
    LtotheK Member Posts: 2,095
    edited March 2013

    Jeez, you really can't win!  What does this mean for general fish supplements? Like 2000 IU/day for Omega 369?

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  • cp418
    cp418 Member Posts: 7,079
    edited March 2013

    http://www.medpagetoday.com/Washington-Watch/FDAGeneral/37676?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&xid=NL_DHE_2013-03-06&eun=g376694d0r&userid=376694&email=jlong@i-review.com&mu_id=5369993

    FDA Panel Says 'No' to Osteoporosis Drug

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  • cp418
    cp418 Member Posts: 7,079
    edited March 2013

    FDA Panels Advise Against Using Calcitonin Salmon To Treat Osteoporosis.

    During the joint meeting of the FDA's Reproductive Health Drugs and the Drug Safety Committee and its Risk Management Advisory Committee on Tuesday, the AP (3/6, Perrone) reports the "federal health experts" concluded that calcitonin salmon should "no longer be used by women because there is little evidence it works and it may actually increase the risk of cancer." The committee members "voted 12-9 that the risks" of the nasal spray - which Novartis markets as Miacalcin and Upsher-Smith, as Fortical - "outweigh its benefits when used to treat brittle bones." Although calcitonin salmon, which is also available in an injectable form, has been prescribed for osteoporosis in postmenopausal women since the 1980s, health regulators worldwide are taking a new look at it after "two recent studies" linked it to a slightly higher rate of cancer.

            Reuters (3/6, Clarke) adds that the combined FDA advisory panel also voted 20-1 that companies developing biotech versions of the salmon hormone must conduct trials to substantiate that their calcitonin products reduce the risk of fracture, effectively. The committees' concerns about safety and efficacy were based on data detailed in a briefing document (pdf) that FDA reviewers released as background material for the meeting. Reuters also notes that last July, the European Medicines Agency recommended against using calcitonin salmon long-term, after a research review showed a slight higher increase of cancer among patients who had used the drug for an extensive length of time to treat osteoporosis.

            MedPage Today (3/6, Pittman) says that after EMA's announcement last summer, Health Canada "issued a statement warning of an increased risk of cancer with long-term use" of calcitonin salmon products. Meanwhile, the FDA conducted an internal review of "more than 20 clinical trials involving oral and nasal-use products and found a slight, but consistent risk of cancer - including melanoma - in the calcitonin salmon study groups." According to the FDA, although calcitonin salmon products "accounted for about 4.5% of all osteoporosis drugs prescribed in 2011, or about 1.7 million packages," its use has declined significantly, since its approval in 1984.

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