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FDA Planning Study of Generic Metoprolol Over Safety, Efficacy Concerns — Physician’s First Watch

Medical News |
May 9, 2014

FDA Planning Study of Generic Metoprolol Over Safety, Efficacy Concerns

By Amy Orciari Herman

The FDA is planning an in-depth study of generic extended-release metoprolol succinate after receiving nearly 3500 complaints related to the blood pressure drug since 2009, Bloomberg News reports. Complaints include both lack of effectiveness and side effects.

The investigation began in response to concerns from a Cleveland Clinic cardiologist who, in 2012, said the metoprolol pills he was prescribing were not working consistently.

The analysis will examine whether generic versions of the drug are "chemically the same as the original" (brand name, Toprol XL). The news article notes that generic makers don't copy extended-release technology the way they do the actual drug. In 2008, over 6 million bottles of generic metoprolol were recalled because they potentially failed to meet certain specifications.

Harlan Krumholz, editor-in-chief of NEJM Journal Watch Cardiology, commented: "The availability of generic drugs can save the health system billions, but we must be sure they have the same risk/benefit profile. This study may herald an era where we begin to ask more questions about the safety and effectiveness of these generics."

The FDA's study may begin by September and could last up to 3 years.

Reader Comments (13)

Antoinette Santangelo

You need to read all of the comments since 2007 about this drug. We have been trying to get it recalled and a lawsuit for it since it. A lot of people have lost loved ones and had horrific side effects from it. It has really taken to long to come to this ...

Martha J Lynch PA-C, Physician Assistant Other Healthcare Professional, Geriatrics, Clinic, SNFs, private homes

I really appreciated Dr Sandoval's cogent discussion of what the law allows with generic drugs and what is fact versus hyperbole about variation with generic drugs.
With that said, it has long been problematic for me, as a provider, in dealing with generic medications in the context of polypharmacy. How is it possible to follow the dictates of good geriatrics, i.e. "start low and go slow" if the drugs are neither reliable, nor reproducible from batch to batch, month to month or manufacturer to manufacturer?
Scandal is the tamest of words to describe this! Failure and rupture of public trust may come closer to the truth. It is a sad day , indeed, when physicians are fearful of what they must prescribe in order not to bankrupt those who seek care from them.

sanjoykumarsatpathy Physician, Internal Medicine, BHUBANESWAR,INDIA

Actually speaking these so called long acting pills be it anti hypertensives or anti diabetic do not work similarly in all ethnic groups.It's like eating one meal for the whole day!Usually i do not like these XL tablets, they are advertisement gimmicks.

GORDON RAFOOL Physician, Geriatrics, Winter Haven

We as physicians are forced to use generics by third party payers. This is not the first time that generic quality has been called into question. With medications in critical doses and diseases that must have the required potency the brand should be allowed. I am sure that will not take place; thus the FDA should monitor those type of medicines first and consistently.

THOMAS RICHARDSON Physician, Emergency Medicine, Hendricks Regional Health

This is without a doubt a problem. We have come to rely on poorly regulated overseas companies for generics and the quality is definitely not as good. I have seen highly variable results with the generic versions of this drug. A family member is on this and every time she goes generic has issues--both with tachycardia and blood pressure.

Jumma Madi physician Other Healthcare Professional, Hospital Medicine, TMC TRIPOLI LIBYA

these observations on generics noted in most of the drugs in particular effecacy . this issue need be addressed and reasised.

Silvio Aladjem MD Physician, Obstetrics/Gynecology, retired

This is not the first time, nor will it be the last. It happened with digoxin as well other products. The truth -you get what you pat for. FDA trial is a step forward. In the meantime, if the drug is given for a potential life/death situation, get the real thing.

richard Kradek,M.D. Physician, Obstetrics/Gynecology, multispecialty clinic

The manufacturer and the site of manufacture MUST be put on prescription labels - allowing patients and providers to trace their drug origin.

annette santangelo Other, Other

This drug was a major cause of my mother's death. this drug dropped her blood pressure to 36 Causing heart problems and kidney problems. I have been asking for it to be taken off the market since 2007. It was originally taken off in 2005 then put back on the market again. WHY if you did not investigate it before? It caused so may deaths since because of the negligence.

MARK LEFFERT Physician, Psychiatry

This is really a scandal. There is a growing body of evidence that some generics are problematic as to accuracy of dosage delivered and the problem is particularly bad with respect to time release formulations. Generic producers seem to have difficulty producing the time release formulation; as a psychiatrist I have learned that there are several drugs that I have to write as DAW. I've found that many/most pharmacists are aware of the problem.

john clark Physician, Emergency Medicine

I suppose there is a reason why

"This study may herald an era where we begin to ask more questions about the safety and effectiveness of these generics."

This didn't occur in 2008. Six years later and we are going to start a study on this issue that is going to take 3 years!!!!

Mary Powell, PHD, CDE Other Healthcare Professional, Unspecified, Neumann University

Yes, generics may save money, but we need to "look a gift horse in the mouth " as they say. Generics may have up to a 20% variability in bioavailability by law. Would we accept a 20% variability in say the strength of steel in buildings? I think not.

Sandoval, Rommie, Ph.D., Pharm.D. Other Healthcare Professional, Pharmacology/Pharmacy

Dr. Powell,
Just a short clarification. The statement that " Generics may have up to a 20% variability in bioavailability by law" is not accurate. By law, a product is considered bioequivalent if the 90% CONFIDENCE INTERVAL OF THE MEAN of the AUC (area under the time vs concentration curve) and the average Cmax (maximum concentration) of the test product is within 80% to
125% of the reference product. This is the SAME standard used to determine bioequivalence of brand-name drugs if the drug products are reformulated (which occurs often)
or to compare different batches of brand-name drugs.

So, no... no product "will vary 20%" in their content!!

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