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    FDA warns of severe joint pain risk with DPP-4 diabetes drugs

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    graham64
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    FDA warns of severe joint pain risk with DPP-4 diabetes drugs

    Post by graham64 on Fri Aug 28 2015, 21:39

    Aug 28 A class of diabetes drugs that include Merck & Co Inc's Januvia have been linked with severe joint pain, the U.S. Food and Drug Administration said on Friday.

    The FDA said it had identified 33 cases of severe joint pain in patients taking a class of drugs known as DPP-4 inhibitors between Oct. 16, 2006, when the first one was approved, through Dec. 31, 2013.

    The most frequent number of cases, 28, occurred with Januvia, known generically as sitagliptin. Five cases were reported with AstraZeneca Plc's Onglyza (saxagliptin) two with Boehringer Ingelheim's Tradjenta (linagliptin) and one with Takeda Pharmaceutical's Nesina (alogliptin).

    The FDA said that in 20 of the cases the DPP-4 inhibitor was suspected as a cause of the pain and was discontinued within a month after the onset of symptoms. In eight of the remaining 13 cases, a period of 44 days to a year elapsed between the onset of symptoms and discontinuation of the drug.

    The drugs are used to lower blood sugar in adults with type 2 diabetes. The FDA said patients should not stop taking their drugs but should contact their doctor if they experience severe and persistent joint pain.

    http://www.reuters.com/article/2015/08/28/diabetes-drugs-warning-idUSL1N1131GD20150828?rpc=401

    DPP-4's and statins now that could be a good combination  bitenails for muscular problems Shocked


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    Proving the LowCarb sceptics wrong for over nine years,

    Not all cherubs are Angels  Wink nor all diabetics Bonkers  Rolling Eyes
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    yoly
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    Re: FDA warns of severe joint pain risk with DPP-4 diabetes drugs

    Post by yoly on Sat Aug 29 2015, 11:47

    http://www.peoplespharmacy.com/2015/08/28/new-fda-warning-about-januvia-joint-pain-side-effect/

    On August 28, 2015, the FDA issued the following caution:

       “The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. We have added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors.”

    The agency specifies that patients should not stop their medication but should contact the prescriber immediately if “they experience severe and persistent joint pain.” The FDA wants health care professionals to understand that drugs in this class can cause serious joint pain and if that occurs they should recognize that it is not necessarily because a patient is “getting older” or developing sudden arthritis. The alert points out that symptoms can start within a day of beginning one of these drugs or come on gradually, after years of use without symptoms. The FDA states:

       “After the patients discontinued the DPP-4 inhibitor medicine, their symptoms were relieved, usually in less than a month. Some patients developed severe joint pain again when they restarted the same medicine or another DPP-4 inhibitor.”

    Januvia Joint Pain Side Effect:

    Over the last several years the FDA has approved a number of new medications to treat type 2 diabetes. They include Januvia (sitagliptin) and Janumet (sitagliptin + metformin), Nesina (alogliptin), Onglyza (saxagliptin), and Tradjenta (linagliptin). Januvia has been widely advertised and is one of the best-selling diabetes drugs, earning billions annually for its manufacturer.
    Januvia Television Commercials:

    Perhaps you have seen the Januvia TV commercials and didn’t even realize it. They promote the idea that the medication “is not likely to cause weight gain,” making it seem like an ideal diabetes drug.

    In one such commercial, a man and a woman are going up and down on a seesaw in an idyllic outdoor environment. Another couple is strolling along the beach with the ubiquitous beautiful dog. As they happily play with a Frisbee the announcer mentions that: “Serious side effects can happen, including pancreatitis which may be severe and lead to death.” But they don’t mention the Januvia joint pain side effect.

    Next we see two guys having fun at the barbecue grill. The female announcer adds:

       “Tell your doctor right away and stop taking Januvia if you have an allergic reaction that causes swelling of the face, lips, tongue or throat or affects your breathing or causes rash or hives. Kidney problems sometimes requiring dialysis have been reported.”

    Other side effects are mentioned, but nowhere in this commercial is there a reference to the newly uncovered Januvia joint pain side effect. Presumably that will now change given the current FDA alert.
    Other Drugs That Will Have a Joint Pain Warning:

    It is not just Januvia, Janumet, Nesina, Onglyza, and Tradjenta that will have to carry cautions on the label about severe or disabling joint pain. The FDA will also require Glyxambi (linagliptin + empagliflozin), Jentadueto (linagliptin + metformin), Kombiglyze XR (saxagliptin + metformin) and Oseni (alogliptin + pioglitazone) to alert prescribers and patients to this complication.
    What About the Problems with the Pancreas?

    Perhaps you noticed the reference to pancreatitis and death mentioned in the TV commercial. These drugs work by stimulating the pancreas to make more insulin. A study published in the journal JAMA Internal Medicine (April 8, 2013) reported that Januvia and another new diabetes drug, Byetta, were “associated with increased odds of hospitalization for acute pancreatitis.” That means inflammation of the pancreas, a painful and potentially life-threatening condition. There have even been concerns raised about pancreatic cancer.

    The FDA has backpedaled a bit on these problems, but another organization, the Institute for Safe Medication Practices (ISMP) has voiced concern in its publication, Quarter Watch, which monitors reports of adverse reactions submitted to the FDA. A publication issued in April, 2013, notes that the FDA has learned of over 800 cases of pancreatitis and more than 100 cases of pancreatic cancer.
    Readers’ Stories:

    Rich shared this story on our website:

       “I was prescribed Januvia in March of 2015. Earlier in the year I had a kidney stone removed and neither a CT, MRI or blood tests showed anything abnormal with my pancreas or pancreatic enzymes. I started experiencing left side abdominal pain in just a few weeks and subsequent tests and a biopsy this month (August 2015) confirmed the presence of a malignant tumor in my pancreas.”

    JL reported the following:

       “Yes, yes, my husband got pancreatitis while taking Januvia and spent a week in the hospital. Doctors said there was no connection but we have since read many corresponding articles. He no longer takes Januvia.”

    SC reported less serious but nevertheless annoying complications:

       “I took Januvia for about a year after it was introduced. I had been recently diagnosed with Type 2 diabetes. I had a constantly stuffy, runny nose.

       “After my Medicare insurer wanted me to try a cheaper medication–metformin–I decided the side effects of Januvia were too annoying and no long term studies had been done so I switched to metformin. It is a safer drug and with a low carb diet, has helped me maintain decent blood sugars.”

    Januvia (sitagliptin) Side Effects:

       Upper respiratory tract infections, nasal congestion, runny nose
       Headache
       Digestive distress, stomach pain, diarrhea
       Joint pain, arthritis
       Serious skin reactions (require immediate medical attention)
       Pancreatitis
       Liver enzyme elevations
       Kidney damage

    We welcome reports from visitors to this website below in the comment section so we can share case reports with the FDA and ISMP. Have you experienced Januvia side effects or has this drug been really good at controlling your blood sugar without adverse reactions? What about other new diabetes drugs?
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    chris c
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    Re: FDA warns of severe joint pain risk with DPP-4 diabetes drugs

    Post by chris c on Sat Aug 29 2015, 18:39

    Scary stuff!

    But not as scary to most doctors and nurses and all dieticians, and a disappointing number of patients, as cutting carbs . . .
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    Eddie
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    Re: FDA warns of severe joint pain risk with DPP-4 diabetes drugs

    Post by Eddie on Sat Aug 29 2015, 18:56

    With respect Chris "and all dieticians" not all dietitians have their heads up their butts. Check out my good friend Franziska here http://www.lowcarbdietitian.com/

    We met Franziska a couple of years ago, a shining example for health and common sense. She was in her late forties when I took that photograph with Jan.



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    Type two diabetic-low carb diet (50 carbs per day) and two 500mg Metformin pills per day. Apart from diagnosis HbA1c almost 12-all HbA1c results none diabetic. For over eight years my diabetes medication has not changed. My weight has remained stable, I have suffered no ill effects from my diet whatsoever. Every blood test has proved, I took the right road to my diabetic salvation. For almost seven years, I have asked medical professionals and naysayers, how do I maintain non diabetic BG levels on two Metformin other than low carb ? The silence has been deafening !
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    chris c
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    Re: FDA warns of severe joint pain risk with DPP-4 diabetes drugs

    Post by chris c on Sat Aug 29 2015, 19:29

    Sorry I of course meant "all NHS dieticians", there are even a few here who have more sense

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