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How Safe Are Generic Drugs?

Updated on November 14, 2015
brakel2 profile image

A medical background and interest in research created Audrey Selig's interest in writing about medical issues.

Problems With Generic Toprol XL

In 2008, a young man sat in his doctor’s office reading Prevention Magazine when an article about a drug recall caught his eye. It happened to be a generic blood pressure medication he was taking for Toprol XL. The article alarmed him, as allegedly all generics/off brand for the medication were recalled. Later, he learned the brand name drug would be dispensed until the issue is resolved. However, following that recall, he hesitated to return to it, due to some problems. In 2014, the same brand name had generic recalls. Should this story alarm you about generic medications?

All drugs undergo rigorous testing before release, and billions of people take generic medication. The recall could have been for a brand name drug. This article will discuss prescription drug safety, follow up on the generic recalls, and cover the high costs of prescription drugs.

Recall

Prescription Bottles
Prescription Bottles

Recall of Generics in Two Companies

In 2014, two companies recalled the generic versions of the medicine, both manufactured in India. Wokhardt issued the recall on 109000+ bottles of the drug after failing tests. This recall was in April, according to Bloomberg News on May 15, 2014. The report also states that the FDA plans to perform a large study of the drug after complaints about lack of effectiveness and disturbing side effects.

Dr. Reddy Manufacturing initiated a recall in April 2014 after failed tests, and the recall involved 13000+ bottles. Both companies had a problem with the extended release medicine not working correctly. Off brand companies must figure for themselves how to process the extended release portion of the drug. A doctor at the Cleveland Clinic had concerns about this drug for some time.

Recalls May Have Caused Illness

Hospitalized Patient.
Hospitalized Patient.

Cleveland Clinic Concerns About Generic Toprol

Dr.Harry Lever from the Cleveland Clinic heard ongoing complaints from his patients about generics of this drug. Dr. Lever, a cardiologist, heard about chest pains and other symptoms and tried to draw some attention to this problem, as the symptoms disappeared if he switched them to the brand name drug made by AstraZeneca. In 2012, he complained to the FDA and later appeared unsuccessfully before Congress. His concern continues that some off brand drugs act different than the brand name, especially extended release medications.

Some People Cannot Tolerate Certain Generic Drugs

Past studies indicate no difference with generics in general, or these particular generics. However,some patients cannot take the off brand due to an allergy to the filler or a problem with the drug itself. Some physicians will write only brand name for heart or blood pressure medicine. This does mean some exceptions occur to nullify a generic drug in unusual circumstances.

Pharmacists Deal with Recalls and Prescription Drug Safety

Pharmacists help you with drugs
Pharmacists help you with drugs

Generic Drug Standards

Generic drugs receive a thorough review before approval. They must meet standards in regard to identity, strength, quality, purity and potency, but fillers\inactive ingredients can be different. Both brand name and generic drugs must meet the same qualifications and approval process as determined by the FDA. The manufacturing facilities must undergo inspections periodically to ensure the safety and cleanliness of the building. Quality control remains of utmost importance to the consistency of the drug.

Once the patent is off the brand name, other companies can apply through a process for off brand approval. This takes some time, and often a brand name company will also make a generic brand. Eight out of ten drugs dispensed to consumers are generic drugs. You can see that the public, in general, has accepted the idea of that version. Some physicians do not like to switch patients from a brand name to a generic, but often no issues arise.

Recalls happen to both generic and brand name drugs. The FDA or manufacturing company can recall medication. Often further testing must take place and sometimes, the drug is totally pulled from the market, or some bad lots are temporarily pulled until corrective action takes place.

The FDA is not infallible. Sometimes politics are involved in the functioning of this Division. The public can complain at any time and often do by completing a form describing the issue.

Drug Costs

One final point relates to the cost of medications. The cost of generic and brand name drugs can be multiples of thousands of the manufacturing cost. Drug companies and not the patient are the benefactors of big medicine. Drug companies have huge lobbying machines and are the winners in this game. Is this fair? This is the price you pay for prescription drug safety.

FDA Recalls

FDA Recalls Medicines
FDA Recalls Medicines

Summary

Are prescription drugs safe? Research shows most generic and brand name drugs perform adequately and receive monitoring. Some patients develop an intolerance to a generic drug, due to allergy to the filler or another extenuating circumstance. In these cases, physicians can write for the brand name. Problems prompt recalls, either off brand or brand name. If you have a complaint about prescription drug safety or a specific drug, you can contact your physician or the FDA. If the medical and drug problems could decrease, you might breathe a sigh of relief and join hands with others in harmony, and a burden would lift like a breath of fresh air. You can never stop believing in hope. If you don't have hope, you have nothing


Disclaimer: If you have any questions, please contact your physician. Audrey Selig has a BA degree in Sociology/Psychology with a background in Medical Social Work as credibility for this article.

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    • hazeltos profile image

      Susan Hazelton 

      2 years ago from Summerfield, Florida

      This hub is like a public announcement, I mean that in a good way. It is imparting important knowledge to all of us. I have used the same generic drugs for years. I had a problem one time, it was a medication for my heart. Once I started taking the name brand drug it became useful once more.

    • brakel2 profile imageAUTHOR

      Audrey Selig 

      2 years ago from Oklahoma City, Oklahoma

      Hi Patricia - Missed this comment and so glad to find it now. Thanks you for reading my hub and for telling us about your drug allergies. Some people do not realize that you can be allergic to some ingredients, and I am so glad you know all about the issues, so you can deal with them. Yes, recalls seem to happen more and more. So great to see you at my hub. Blessings, Audrey

    • pstraubie48 profile image

      Patricia Scott 

      3 years ago from sunny Florida

      This is so important for everyone to read. I have so many drug allergies that caution is the word.

      If I am not mistaken I heard on the radio just the other day about another generic drug recall.

      Thank you for sharing this with us.

      Angels are on the way to you this morning. ps

    • brakel2 profile imageAUTHOR

      Audrey Selig 

      4 years ago from Oklahoma City, Oklahoma

      Thanks Billy A compliment by you is the greatest gift I could receive. A hearty congratulations for your hubbie award. You certainly deserve it for all the hubs and especially for writing tips. I hope it made your day. Thank you so much for stopping by to read my hub. You are the best. Blessings, Audrey

    • billybuc profile image

      Bill Holland 

      4 years ago from Olympia, WA

      More very useful information. I love that you are writing articles like this. A writer who raised public awareness is a valuable asset for any society. Well done my friend.

    • brakel2 profile imageAUTHOR

      Audrey Selig 

      4 years ago from Oklahoma City, Oklahoma

      Hi Flourish - I am sorry you are having trouble with generics. I know the druggists swear by them and will always tell you there is no real difference. My druggist said that about the generics in this article, but I guess he cannot make personal comments. He did tell me that they handle the generic made by the brand name company. That is a good sign. Anyway, I hope you get some relief from this issue. Medications are so important to our health, along with the strides we make for ourselves. Thanks for reading so many of my articles and making good comments. Blessings, Audrey

    • brakel2 profile imageAUTHOR

      Audrey Selig 

      4 years ago from Oklahoma City, Oklahoma

      Hi Rachel - Thanks for reading my article about the timely issue of generic recalls. It is an important safety message, as you say. You are getting so involved with this site, and I enjoy reading your articles, along with the ones by awordlover. Hope you had a great weekend and that things are going well for you now. Blessings, Audrey

    • FlourishAnyway profile image

      FlourishAnyway 

      4 years ago from USA

      I've noticed that some of my generic Rx meds that I've been on awhile just aren't effective -- whole bottles seem to be "bad." This would totally explain it.

    • RachaelOhalloran profile image

      Rachael O'Halloran 

      4 years ago from United States

      This is an important public safety message. Thank you! Voted up and Shared on HP & Google.

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