FDA Probes Generic Toprol XL Effectiveness Following Complaints

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Irvin Jackson

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An investigational study has been launched by federal drug regulators to look into generic versions of the blood pressure drug Toprol XL, following thousands of complaints received from doctors and patients, which are not being seen among users of the brand-name drug.  

The FDA has received reports of problems involving generic metoprolol succinate, which suggest that the medication may be less effective and causes more side effects than AstraZeneca’s Toprol XL.

All generic drugs are required to be bioequivalent to the brand-name products they imitate; meaning they should be just as effective and have the same risk of side effects.

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On April 16, the FDA announced it will fund a number of generic Toprol XL studies to test whether the generic versions are actually equal to the brand name drug. The Department of Health and Human Services (DHHS) has indicated that it is taking applications from researchers seeking a grant to conduct the study to its requirements.

So far, the FDA has been unable to pin down on its own the cause of the complaints or to confirm that there is some difference in the generic Toprol XL products manufactured by Actavis, Dr. Reddy’s Laboratories, Mylan Inc. and Wockhardt Ltd.

“Therapeutic inefficacy and adverse events have been reported by physicians and patients switching from brand to generic metoprolol extended release products,” the grant application states. “The FDA continues to monitor the FDA Adverse Event Reporting System (FAERS) for reports relating to currently marketed metoprolol products. However, based on current data available to the agency, it is difficult to draw definitive conclusions about the cause of the concern.”

Since March 2009, the FDA has received more than 3,400 adverse event complaints involving generic Toprol XL. However, the reports do not identify which generic versions are causing the problems; they only state that they are not the brand-name product by AstraZeneca.

One of the manufacturers, Wockhardt, Ltd., manufactured generic Toprol XL at a facility in India that was banned from shipping drugs to the U.S. in November 2013, after the FDA found out that its workers were providing false information on quality control tests. The facility was also found to be unsanitary. Before the factory was banned from sending drugs to the U.S., it accounted for a quarter of all generic Toprol XL.

Novartis also used to manufacture the drug, but stopped following a massive recall in 2008 that affected about 6 million bottles. The recall was issued after the FDA declared that the drug did not meet the agency’s quality standards.

Irvin Jackson
Written by: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.

Tags: Actavis, AstraZeneca, Dr. Reddys, Generic Drug, Hypertension, KV Pharmaceuticals, Mylan Pharmaceuticals, Toprol, Wockhardt
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8 Comments

Ronnie
Powerful drug even 25 mg I am a male 60 yrs old. Caused ringing in left ear. Fatigue. Sever couldn’t get out of my tracks Shouldn’t be taken by anyone at all poison Soul robber zombie. I would rather die than to ever take it again I think the manufacture ought to take some see how they like it an the drs too 7 months of my life gone Poison. Stay away
Ray
I am on 25 mg, not problems so far. Speaking for my wife, one month metropol, 100 mg day, nothing but dizziness, memory loss, confusion, etc. Continuing to complain, changed drug to atenanol, 50 mg. For one day, no change. New Dr stopped drug today, evaluate wed., 4 days from now. Looking for similar mental/emotional usdues
Lynnwood
I used to take Lopressor and was great for years…it then was not covered by my insurance, but i paid for it anyway, then my doctor suggested saving money and try the generic….metoprolol……within a year i started to get very dizzy after 2 years or so i began getting vertigo, serious vertigo and loosing my balance even when not dizzy….i was told to stop the medication, put on brand Toprol….feeling much better. vertigo almost gone but I am left with an imbalance. I wanted to know if there was any kind of Law suit going on….because that drug changed my life! Lynnwood Bohm
Ian
Had bad accident on this medication, and just did 12 years in prison after I suffered hallucinations…, and did have a psyhiatriatric disturbance, i couldn’t do anything while in prison…. accident happened in dec. 29th, 2004.
Levi
This medication has side effects that is not good beware I developed A big tissue mass on the left side I had to have surgery to remove it and now it came back on the right side .
Joann
I was recently diagnosed with a heart conditions warranting being started on a low dose beta blocker..i was put on generic toprol extended and within the first 6 hrs I literally felt like I was dying. I am 55 yrs old and exersize everyday after this first pill I was so sick I grabbed the bottle and looked at the side effects and I was definitely a very sick woman…i’d like to speak with someone to discuss this with Im having a hard time understanding why a drug manufacturing a medication that makes people sicker and especially. A heart med. Why would they continue to put patients at risk for death. Im very upset and think we need to stop this drug I cant imagine how scared other heart patients must feel with the fear of already knowing your heart is in trouble and then a drug that clearly has had problems in.the past is still being made readily available to the doctors to prescribe. ..please call.me and see if we can get this product off the market so no one else dies from it hitting. Them in the pocketbook might open thier eyes. Just grateful to be alive tofay.
Ann
My father was given the generic of Toprol the first of this year and we were not aware of any problems until he started having swelling and shortness of breath. We checked his medication and realized that he started getting the generic version around the 1st of this year sometime. He was hospitalized after falling and not being able to get up. After being placed back on name brand Toprol, within a few days he was getting better and was back home in a week. He developed Pneumonia around September and started having the swelling symptoms again and shortness of breath due to the Pneumonia and his still weekness from the 1st hospitalization of this year. He was put back in the hospital for Pneumonia; the hospital messed up and was giving him the generic Metoprolol for about a week. I realized the symptoms again, and double checked with the doctor who stated he was taking the generic and she would make sure he was changed back to the name brand Toprol. He was recovering from the Pneumonia, but was still swelling and had shortness of breath, but began to get better once switched back to the name brand medication. He went to rehab and was getting better, however he suffered a fall due to his weekness and has died from that fall, even though they put heart disease on his death certificate. I believe that if had not been given this generic medication the 1st of this year, he may still be with us.
Mininek
I have been taking Metoprolol ER and Amlodipine Besylate for years but had to stop because I am suffering from arthritis symptoms and peripheral issues. I went to a doctor about it and he advised me to stop taking my medication because of the problems that developed. My blood pressure has gotten worse.

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