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Lilly's Effient steps forward, then back

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Eli Lilly and Co. just can’t catch a clean break on its newest drug, the blood thinner Effient. A day after doctors were alerted to a black-box warning that could slow sales of Effient’s main competitor, Plavix, a medical journal published research showing that patients suffered 43-percent more cancer tumors on Effient than on Plavix.

Plavix is the leading blood thinner. Its makers, New York-based Bristol-Myers Squibb Co. and France-based Sanofi-Aventis SA, raked in $9.5 billion in sales from the drug last year.

Effient, by contrast, has recorded just $35 million in sales during its first three quarters on the market. At one time, investors hoped Effient would save Indianapolis-based Lilly from its looming raft of patent expirations, but their ardor has chilled substantially.

Lilly executives have remained upbeat about Effient, saying it’s the kind of drug that must receive a complex series of approvals from hospitals, insurance companies and the government-run health plans of European countries. As it does so, they predict, sales will increase.

Effient is approved for use only in patients undergoing hospital-based procedures, such as the implanting of stents. Lilly hopes its ongoing clinical trials of the drug allow Effient to be used in more settings in the future, as Plavix is.

The black-box warning about Plavix, ordered in March by the U.S. Food and Drug Administration, was detailed Monday in an alert issued by the American Heart Association and the American College of Cardiology Foundation. The drug cannot be metabolized, or broken down, by some patients, so the medical groups made three main recommendations to doctors, including a suggestion to consider Effient.

“Realize that there are other drugs out there that are alternative,” the alert read. “Prasugrel [the chemical name for Effient], for example, is one option, but its benefits must be weighed against its bleeding risks.”

Effient has been controversial since Lilly and its development partner on the drug, Japan-based Daiichi Sankyo Co. Ltd., announced results of a head-to-head trial against Plavix in November 2007. Effient reduced by 19 percent patients’ incidence of heart attacks and strokes compared with Plavix, but also increased bleeding and fatalities from bleeding.

It took the FDA a year and a half to untangle those complex results before it approved Effient last August. The FDA gave the drug a black-box warning for its bleeding risk.

One of Effient’s strongest critics, Dr. Sanjay Kaul, was excluded from the FDA’s review committee after Lilly complained that he was biased.

Now, as the Archives of Internal Medicine published a study Tuesday documenting the higher rate of tumors in patients taking Effient, Kaul renewed his warnings about Effient.

“Sufficient credible evidence has emerged to raise concerns about a potential risk,” wrote Kaul, a cardiologist at Cedars-Sinai Medical Center, and George Diamond, a cardiologist at UCLA, in an editorial in the Archives of Internal Medicine. According to Bloomberg News, they recommended Effient be used only for weeks, not months, until further research is done.

But Lilly and Daiichi answered that the cancer risk was examined and dismissed by the FDA reviewers of Effient. In a statement, the two companies said, “It is important to note that the hypotheses [about Effient’s cancer risk] have been previously presented and published as well as reviewed, discussed at length and addressed by the U.S. Food and Drug Administration.”

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  • no problems
    Had a heart attack Jan first.. On effient.. Only issue is mild nose bleed. After sneezing..
  • Drug reactions
    Included among my group of coronary problems is Coronary artery disease. I have 4 stents in a row in my LDA. With the first two stents they gave me Plavix. Withing 3 weeks each time I developed debilitating severe joint swelling, a different joint every 12 -18 hours.Dr. thought it was fractures or something else. Disappeared 48 hours after discontinuing Plavix. For the last set of stents they gave me Effient. After 6 weeks starting getting severe bruising, especially around joints but no swelling. Took me off it after 8 weeks and say I don't need the drug anymore as stents are drug eluded and risk is gone after about a month. don't know that I totally believe that but wanted to get this out to those of you having reactions like mine
  • Been on Effient for 8 Mos
    I am a 41 year old male and had quintuple bypass surgery on 5/3/12. Was put on Plavix along with a multitude of other meds. Went back in on Sept 29th and had five stents put in and was switched to Effient. I haven't had any real side effects except for the easy bleed (Don't bite your tongue!). I too received a co-pay card from my cardiologist but it has expired. Does anyone know if there is a way to renew it or do i have to go and beg the Dr again. Also, the cancer scare is bad news. I'll probably end up switching back to Plavix anyway.
  • Rash while on Effient
    Suffered a heart attack in October of 2011 and got two stents plus was put on Plavix. But I broke out in a rash and was switched to Effient in January of 2012. Now I have developed a rash again and believe it is related to the Effient. Never heard of this cancer risk until now so I am pretty worried. Am waiting for my doctor to respond to a message. So if I can't tolerate Plavix or Effient, does anyone know my options?
  • effient
    Thanks for sharing, Denise. Sorry for your loss. I have just been prescribed effient by a doctor and am fully sure he is in the Pharmaceutical company's pocket. After a week i feel awful and have nosebleeds. i didn't even have a stent or angioplasty, just an angiogram. I will pursue alternatives through diet and supplements.
  • Mom Diagnosed with Cancer 4 Months After Taking Effient
    Please, please stop taking this drug. My mom had stent put in in Nov 2011. Chest x-ray clear then. Took Effient for 4 months. Started coughing up blood early in March and chest x-ray done. Cancer all over lungs which had metasticized from Thyroid. VERY aggresive cancer. She passed in early September. Due to the increase in cancer risk of this drug, please do not use, especially for long periods of time. This drug is very questionable.
    • HELP ME!!!
      My nose does not stop bleeding. I have had my nose corterized 2x in the last week!!! I'm sooo tired!! On Effient after being taken off of Plavix!! I have to fly next week to be with myy mom and I'm soooo nervous to fly!!!
    • Diarrhea
      Heard only one comment about this side effect. However, took my first pill last night and big problem this morning. In your experience, is it transient, persistent, or never had it? Thanks,
    • GET THE SPELLING CORRECT - PLEASE!
      People - it's STENT not STINT!! A "stint" is a period of time spent doing something i.e. a two-year stint in the army. A "Stent" is a small, expandable tube used for inserting in a blocked vessel or other body part. The least you could do is know the difference.
    • Effient
      I had a stroke a month ago. They changed alot of my medications. From 325m Aspirin to 81m Aspirin and added Effient as a blood thiner. My right arm feels very stiff and my muscles are very hard all the time. My bootom on my right foot is like cement. Does any body knows if Effient has similar effect on any body else. I also take other medication for Blood pressure and for diabetis.
      • Beware of Effient
        I am a 76 year old and have been fighting with coronary artery disease since '87. Have had two separate bypass surgeries: 87 and 96. Since then have had 7 heart attacks and 18 angioplasties with 18 stents implanted. The last incident occurred on 5/1/12. At that time my doctor changed one of my 24 meds from Plavix to Effient. Well, as it turned out, the Effient was not well tolerated and I experienced all of the adverse side effects with the exceptions of stroke, heart attack, and death so far...The pain in my joints was crippling, the diarrhea was disabling, the headaches were unreal, I also experienced brain flashes which were like a flashbulb going off in my head during which time I was disoriented, the burning sensation of my face along with hives, low grade fever were so bad that after just about 10 days on effient I went to the ER. The ER doctor coordinated with my cardiologist and they stopped the effient and put me back on Plavix. It took another two weeks or so to get the effient out of my sysem. It has left me with dizziness and fatigue like I never had before. On the literature which accompanied the effient, I believe that it did not highly recommend the effient for people over 75. So, here I am still doing my thing; I read a great line in a Philip Roth novel which said: "Battling old age is not a war; it is a MASSACRE!" God bless and good luck to all and just remember not a darn one of us gets out of here alive and there are no happy endings. SemperFi
      • I am Diabetic
        My blood sugar levels have been so high since I started Effient I am getting numbers in the 400's and cannot get it under control.
        • side effects of effient
          I too had the stiff, swollen and very painful joints after stint placement. An autoimmune response made it almost impossible to use my hands. These issues were not from the Effient but from a statin used to control cholesterol post MI. Upon stopping the statin and using another (although not as effective) drug called Welchol, my hands and joints slowly returned to as close to normal as they are going to get. Those of you having the same problem as I might want to look at your other medications as well.
        • effient
          drs also have samples of effient in their office,sometimes they will actually give you samples i got them for over a year
        • Effient usae
          Did not at all meet profile for LDA 100% blockage widow maker attack 7/10/11. wo stents placed and put on Effient. Cause bleeding with slight cut and bruising. Also tired a lot. I am switching off pharma to naturals reco by Dr. Joseph Marcola & others.Using most items now.
        • Was on Plavix, now on Effient
          I was taken off Plavix because severe itching on legs, arms and scalp.I have been on Effient 3 days now, still itching, I am a bit short of breath,have some palpitations and nausea,some pain in hand joints. Worry about this medicine. Good luck to all of us who needs it.
        • Effient User
          Had 1 Drug Eluting Stent installed 07.05.11. Been on 10mg Effient since w/ no apparent side effects. Am very concerned about the tumor risk though!
        • Genes req'd for Plavix
          I was part of a study (by Medco)in early 2011 that involved determining whether or not I had the right genes for Plavix (I was on Plavix at the time). A Plavix user must have two specific genes in order for your body to metabolize that drug. Apparently, 75% of the people have both genes and 20% have only one gene, which reduces the drug's effectiveness. The other 5% have neither gene, so plavix is useless to them. Therefore, before switching to Plavix, you had better get your genes checked. My results showed that I had one of the two genes, so my doctor switched me to Effient. I am tired a lot of times, but I don't know if it is due to Effient or not.
        • Effient or Plavix
          To Mr. David Riffel - Can you provide update on whether you changed from Effient to Plavix and if so, any changes?
        • Discounts on Efient
          My husband recently had a stint placed and was put on Effient along with various other medications. The Effient was $226 a month at our local pharmacy but his cardiologist provided us with a Effient Co-pay card that is good for 12 months and it provided his medication for $20 a month. Ask your cardiologist or check with your local hospital and see if they have a pharmacy clinic program that can help you to get one. If all else fails contact the company and ask them about the card....my husband's cardiologist was provided with the co-pay card by the Effient drug representative.
          • Effient
            New patient. Wow Medication over $200.00 for Effient subscription for one month! I asked for a gereric. Pharmacist said a new drug must be out 7 years before competative companies can come out with a less expensive generic. No complaints with the medication except for the price.
          • mrs
            Which drug causes this effient or plavix. I have noticed my hands and fingers are stiff. I take effient
          • mrs
            I had a drug card given to me by the Dr for effient. Maybe plavix has one
          • Effient
            In reference to David W. Jones, I also have this intense itching usually arma and legs. It develops pateecki. Little purple spots, I guess blood rising to top of skin. The next day after I scratched the spot it is soooo.....sore, like I've been kicked by a mule. There is hives like. I had MI 4/17/ll, stent placement right, started on Effient. Previous had episode 2/09 , stent placement in widow maker 75% blocked, was started on Plavix had been on it until heartache this time. I also get these little purple spots for no reason. They leave in a couple weeks. I'm also on Toprol extended release. started out 25mg then family Dr. raised to 50mg. I was so tired, dizzy, weak. I split it morning and half nightime. Effient has these side effects also.
          • throat problem
            I too have had the throat problem, didn't know what could cause it...interesting. Have been on 10 mg. since Feb. 2011
          • Plavix vs Effient
            I had terrible bruising from Effient. A bump on the finger could bruise my whole hand. My Dr switched me to Palvix and I've had no bruising since. I do have the terrible back pain, mostly in the am, but can handle it as it subsides as the day goes on. I don't think I would consider Effient again. One reason is the enormous cost and, as far as I can tell, Plavix works just as well. Only time will tell
            • Back pain
              I am taking Effient 10 mg qd along with ASA 162 mg. post MI/angioplasty/bare metal stent placement and have ongoing back pain. Considering the alternative, I can deal with the back pain.
              • No major side effects except
                I've been on 10 mg daily since late Mar 2010. Mostly no side effects, although had severe arthitic-type pain for a month after dietary change to more meat, less carbs in an attempt to lose weight. Naturally, no idea whether or not any cancer/tumors have started growing. Probably wouldn't know until too late. No insurance, so I can't afford to do a lot of testing.
              • effient 10 mg
                has anyone had problems feeling like something in throat not being able to breathe or lay down while taking effient?
                • effient
                  i had a heartattack last oct 12 2010 had 2 stents put in my rca and was put on effient and have had no side effects except bloody nose in mornings sometimes
                • hyperglycemia
                  I have had a patient tell me that his blood sugar has been out of control since he started Effient. Have there been comparable remarks from other patients?
                  • Effient after stent placement
                    Had 99% blockage in 4 arteries. Placed stents in 2 of them. Was given Effient after release from hospital. No side effects except slight amount of blood while blowing nose in A.M. for about a week. Eventually went away. Doctor gave me Effient noting it had better properties in protecting blood vessels from getting buildup on the blood vessel walls. Only been on it two weeks, the jury is still out on long term effects. I do need special documentation from my doctor to my Rx provider as this drug is not on their formallary.
                  • Retired
                    Had 2 stints put in in May 2010. Been on Plavix since, no problems. Went into donut hole in June 2010. Ordered plavix, insulin & my wife's anti- depression medication from Canada.Saved Approx $600.00. Will re-order from Canada.
                  • dead man walking
                    4 weeks ago i had a stent in my left main aorta,what was blocked 99%.The Effient 10mg working just fine,without any side effect.I should be dead,because the blockage but i am a sportsman not overweight ,low blood-pressure,low cholesterol no symptoms of heart problem and from the blue sky the blockage.Why ,nobody gave me an answer
                  • 16 months and counting
                    Effient user since 09/09. Second angioplasty, 6 stents total. No side effects. Had been using Plavix for over 4 years prior and developed a clot 1 week after temporarily discontinuing due to a surgery.
                  • 16 months and counting
                    Effient user since 09/09. Second angioplasty, 6 stents total. No side effects. Had been using Plavix for over 4 years prior and developed a clot 1 week after temporarily discontinuing due to a surgery.
                  • So far so good
                    I've been taking effient since june 2010 for two stents inserted due to high blood pressure and cholesterol heart attack. Also I had emergency surgery in October for an umbilical hernia. The surgeon was concerned about bleeding and side effects but none so far. I have had only a pain in my back right shoulder blade on occasion. Nothing like the side effects I am reading. I will have the cancer tumors checked out as I return to the doctor in March. God bless you all who are having problems. I hope everything works out for you all
                  • misspelled Plavix
                    I realized I hit the (c) at the end of Plavix, let me know if you have had problems with Plavix, thanks
                  • arthritis flare-up after using effient 12/20/10
                    after taking effient for almost one month I had severe pain in my joints. After two visits and calls to the Dr. Iwas advised by my cardiologist to go to the ER. On Sunday Dec.19 I was given steroids, within four hours I move without hurting so badly. I am taking prednisone for the next eight days. I was switched from effient to plavic. Good luck!
                  • effient side effects
                    After angioplasy, I was prescribed Effient. I developed a nosebleed within 8 hours of taking this medication. After reading of warnings of posible fatal internal bleeding (which I see no reason to doubt), as well as documented increases in cancerous tumors, I will be contacting my doctor today to get me off of this wonderful new drug.
                    • joint pain
                      i have taken effient for three weeks after a heart attack, i can hardly move my arms and legs because it is so painful. a very painful lump on my spine was due to bleeding under the skin.should i continue to take effient?
                    • Need info immediatley
                      My husband had almost fatal nosebleed with plavix. Doctors want him to take Effient since he had to have stent put in. Will it not cause bleeding also.
                      • husband stopped taking this med. urprunmptly,,
                        he did take plavix has had to heart attacts.last stent,put on effient very sick right now,,, i need more info,, on this med...and how can we get a discount of some kind...??
                      • Allergy to Effient
                        I am suffering the same allergic reaction to Effient as I did to Plavix 12 years ago, albeit not as severe. Plavix caused hives, Effient causes intolerable itchy rash.
                        • Risks!
                          If you have any type of arthritis be careful took this drug for 3 months after stent placement and now can hardly walk or use my hands it sets off autoimmune into a full attack!
                        • need more info
                          please send me more info on this drug i am a plavix user myself and have been for awhile now i was just wondering if i should change or stay with plavix i've had 2 heart attacks and a triple bypass some years ago please send more info thanks

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