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Recalls

Each year, the number of medical devices and drugs on the market increases, and so do the recalls and safety alerts. Manufacturers “voluntarily” pull problematic products off the market, but the U.S. Food and Drug Administration has little enforcement power to force Big Pharma to remove problematic products. As a consumer, it is important to be aware of devices or drugs that may affect your health.

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    Each year, more drugs and devices hit the market. Unfortunately, this may also mean more drug and device recalls. In 2015, there were about 4,672 recalled drug and device products, according to the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. Of those recalls, the U.S. Food and Drug Administration classified 405 as Class I. Class I recalled products have the potential to cause serious harm or death.

    Most people expect the FDA to protect public safety by forcing manufacturers to remove dangerous drugs and devices from the market. But, the FDA does not have the power to enforce a drug recall, and it can only recommend a recall. Often, the manufacturer must initiate a recall, and the FDA does not require manufacturers to notify patients of the recall.

    With the current system, critics say it is too easy for manufacturers to put profits before people.

    In a 2015 data review by Drs. Upendra Nagaich and Divya Sadhna published in the International Journal of Pharmaceutical Investigation, researchers found an increase in the number of drug and device recalls over the last several years.

    "Major drug recall history suggests that lots of carelessness is involved during the drug development and manufacturing period," study authors wrote. "The long list of drug recalls on FDA website is evidence that still industries are not following the standard guidelines issued by FDA."

    FDA Recall Classifications

    The FDA defines a recall as an action taken by a firm to remove a product from the market. Recalls typically start with the drug or device manufacturer's own initiative, by FDA request or by FDA order. The FDA classifies each recall by class depending on the severity of injury that the product may cause. In addition, manufacturers may conduct market withdrawals or medical devices safety alerts. The FDA also announces the recall, withdrawal or safety alert on its website.

    • Class I recall - This is the most serious type of recall. There is sufficient probability that the product will cause serious adverse events or death. Products such as pacemakers, heart devices and lifesaving drugs fall into this category.
    • Class II recall - The majority of recalls fall in this category. Products under a Class II recall can cause temporary or reversible adverse events. Many medical implants, such as hips or knees, fall in this category. Injuries from Class II devices can still be serious, though are not typically life threatening.
    • Class III - These products are not as likely to cause injuries.
    • Market withdrawal - Products withdrawn from the market have minor violations. The manufacturer will pull the product from the market or correct the violation. These products don’t typically show evidence of manufacturing problems.
    • Medical device safety alert - Manufacturers or the FDA — usually both — will issue an alert when a medical device may cause risk of serious harm. Sometimes, these are also recalls.f
    FDA Inspects Drugs and Devices
    "People injured by drugs and devices may turn to the legal system for help."

    FDA Recall Authority

    Many Americans believe the FDA has the authority to remove any harmful product from the market. But, the agency cannot compel a mandatory recall of drugs. However, the FDA may order a manufacturer to recall a medical device by statute if it finds there is reasonable probability that a device may cause serious injuries or death.

    The FDA may also compel a mandatory recall if it finds products made of human cells or tissue may be a serious risk of infection to humans or does not protect against communicable diseases. Vaccines and blood products fall into this category.

    Currently, the agency can recommend a recall, but cannot force a company to remove a product from the market. The FDA can sue a company that does not follow its recommendations, but because of lack of resources this rarely occurs. As a result, drugs linked to the risk of serious side effects and injuries may remain on the market for years.

    In Feb. 2017, Rep. Rosa DeLauro (D-CT) proposed a new bill that will allow the FDA to stop companies from selling over-the-counter or prescription drugs that may cause harm. The Recall Unsafe Drugs Act would grant FDA the ability to issue a mandatory recall on a drug.

    The Drug and Device Recall Process

    Before the FDA can recommend or conduct a recall, it must review the drug or device. There are several criteria and steps in the recall process.

    Health Hazard Evaluation and Recall Classification

    When the FDA identifies a product for possible recall — usually, through adverse event reports — it will conduct a health hazard evaluation. The agency assembles a special committee of scientists to review the drug or device. The FDA then assigns the recall a class based on what the committee finds.

    The committee takes into account the following factors:

    • Diseases or injuries that may have already been caused by the product
    • If the product could expose humans or animals to hazards (documented with scientific evidence)
    • The level of hazard to special segments of the population, such as children or the elderly, and those who could be at greatest risk
    • The seriousness of the health hazard and level of risk to exposed populations
    • Consequences of long-term or immediate health hazards

    FDA Recall Strategy

    After the FDA classifies a recall, it works with the manufacturer of the recalled device or drug to develop a strategy to notify the public. The strategy takes into account all the information learned from the FDA committee. The FDA and manufacturer will then issue a public warning using the general news media or specialized news media, depending on the audience. After the manufacturer issues the recall, the FDA conducts effectiveness checks to ensure the recall proceeds properly.

    The FDA creates a strategy with several factors in mind, including:

    • Results of health hazard evaluation/li>
    • How easily consumers can identify the product
    • How many unused products remain on the market
    • Depth of the recall and consumer level (patient, retailer, health professional)

    FDA Requested Recalls

    The FDA may request a manufacturer initiate a recall after it determines a product poses risk of illness, injury or consumer deception. This typically happens when a manufacturer has not already taken action to initiate a recall of a possibly dangerous drug or device.

    The FDA takes the following steps when requesting a recall:

    • Notify the manufacturer by phone or in person visit of the intent to request a recall
    • Send a letter notifying the company that they must immediately recall a product
    • A formal letter provides the manufacturer with all the information the FDA garnered from its health hazard evaluation and recall classification

    Recall Communications

    The manufacturer works with the FDA to conduct its recall but is responsible for notifying its customers — such as doctors and hospitals — of the recall. Recall communications should be brief, identify the product and the reason for the recall. The FDA provides a weekly FDA Enforcement Report with all new recalls and their classifications on its website.

    Other information included in recall notifications, include:

    • The recall classification
    • Possible health hazards posed by the product
    • Number of products being recalled
    • The lot numbers or other identification numbers
    • Instructions on how to contact the manufacturer
    • Instructions for returning recalled products to the manufacturer

    Recalled Drugs and Devices

    FDA approval or clearance does not mean a drug or device is safe. Over the years, there have been thousands of drug and device recalls. Some recalls have been for minor issues such as package errors. But, other products were recalled for serious side effects or manufacturing defects that caused injury. In some cases, a manufacturer will issue a recall and return the drug or device back to the market.

    Manufacturers may spend millions on a product recall or lawsuits filed against them from recalled products. For instance, the most expensive drug recall to date occurred when Johnson & Johnson recalled 31 million bottles of Tylenol tainted with cyanide. It cost the company $100 million.

    Merck recalled its painkiller Vioxx and lost $275 in sales. In 2007, it paid $4.85 billion to settle about 27,000 lawsuits.

    Some notable recalls pulled from the market include:

    Drug or Device Use Recall Date Reason for Recall Years on Market
    Accutane (isotretinoin) Acne June 2009 Birth defects, bowel disease, suicidal tendencies 27 years
    1982 to 2009
    Baycol (cerivastatin) Cholesterol reduction August 2001 Rhabdomyolysis, deaths, hospitalization 3 years
    1998 to 2001
    Cyclert (pemoline) ADHD/ADD October 2010 Liver toxicity 30 years
    Darvon and Darvocet (propoxyphene) Pain relief November 2010 Heart toxicity, more than 2,000 deaths 55 years
    1955 to 2010
    DePuy ASR Hip Implant Hip implant 2010 Early failure rate, metal ions in blood, device design 5 years
    2005 to 2010
    DES (diethylstilbestrol) Prevent miscarriage, premature labor and pregnancy complications 1971 Cervical cancer, birth defects, increased risk of death from breast cancer, infertility in children and grandchildren 31 years
    1940 to 1971
    Ethicon Gynecare Morecellex Surgical tool for hysterectomy, myomectomy 2014 Increased risk of spreading uterine cancer 10 Years
    2006 to 2014
    Kugel Hernia Patch Mesh for hernia repair 2005 Bowel perforation, fistula 9 years
    1996 to 2005
    Rezulin (troglitazone) Type 2 diabetes 2000 Liver toxicity 1 year
    1999 to 2000
    Vioxx (rofecoxib) NSAID for pain relief 2004 Increased risk of heart attack and stroke, more than 27,700 heart attacks or sudden cardiac deaths 5 years
    1999 to 2004

    Author

    Michelle Llamas is a writer and researcher for Drugwatch.com. She is also the host of Drugwatch Radio and has appeared as a guest on podcasts and radio shows.

    View Sources
    1. Brennan, Z. (2017, February 16). House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal. Retrieved from http://www.raps.org/Regulatory-Focus/News/2017/02/16/26852/House-Bill-Seeks-to-Add-Mandatory-Drug-Recall-Authority-to-FDA%E2%80%99s-Arsenal/#sthash.ilSHc2NO.dpuf
    2. FDA. (2017). Recalls, Corrections and Removals (Devices). Retrieved from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/#3
    3. FDA. (2016). CFR - Code of Federal Regulations Title 21. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=7&showFR=1&subpartNode=21:1.0.1.1.6.3
    4. ProCon.org. (n.d.) 35 FDA-Approved Prescription Drugs Later Pulled from the Market. Retrieved from http://prescriptiondrugs.procon.org/view.resource.php?resourceID=005528
    5. FDA. (2015). FDA Enforcement Statistics Summary Fiscal Year 2015. Retrieved from https://www.fda.gov/downloads/ICECI/EnforcementActions/UCM484400.pdf
    6. U.S. Department of Health and Human Services. (2000, March 21). Rezulin to be Withdrawn from the Market. Retrieved from https://www.fda.gov/ohrms/dockets/ac/00/backgrd/3634b1a_tab6c.htm
    7. Nagaich, U. & Sadhna, D. (2015). Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4286830/
    8. Bloomberg. (n.d.). The most Expensive Product Recalls. Retrieved from https://www.bloomberg.com/news/photo-essays/2013-01-17/the-most-expensive-product-recalls
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