Prescription drugs are at the forefront of news reports these days. Whether it’s due to prescription drug abuse, addiction or a defect in a specific drug we are constantly hit with a barrage of stories on the subject. The most shocking of these stories deals with drugs that are prescribed, used for their intended purpose and still injure the user. This is truly the gravest injustice of all. When pharmaceutical companies release these drugs that are supposed to give people back a quality of life and in some cases save lives and these drugs injure or kill instead, who is responsible?
Who Takes Responsibility For This Harm?
Manufacturers of pharmaceutical products, including prescription and over-the-counter medications, medical devices, dietary supplements and herbal remedies have a responsibility to ensure that their products do not injure or kill the people they are supposed to help. But many people wonder, how do these dangerous drugs get to market in the first place?
The Food and Drug Administration (FDA)
Every new drug must be submitted to the FDA. Approval from the FDA must be obtained for the drug to be released to the public as a prescription drug. New drugs are reviewed in a process which begins with the filing of a New Drug Application. The application does include research on effectiveness and side effects, but many critics comment that this research is oftentimes conducted by the same party seeking approval thereby diminishing the research findings.
Once approval is obtained, the pharmaceutical company must address and report every adverse effect the drug produces to the FDA. Serious and fatal adverse effects must be reported within 15 days of discovery. However, other less serious side effects are required to be reported only on a quarterly basis. The FDA also employs a voluntary reporting program called MedWatch where consumers and health professionals may report side effects.
These are the only safeguards between the public and dangerous drugs once they are given new drug approval by the FDA. Many critics argue, and rightly so, that these safeguards aren’t enough. What sort of benefit is there for a pharmaceutical company, who is making millions of dollars off a new drug to report adverse side effects? Furthermore, how are we as the general public to know when our health problems are caused by a new prescription drug?
The Sad Truth
Many prescription drugs with deadly or dangerous side effects are often rushed to market without adequate testing. These dangerous drugs lead to countless injuries and deaths before they are identified by the FDA as having dangerous side effects. If we are to depend on pharmaceutical companies to monitor their own drugs, which produce huge profits, how safe can we really feel?
So how big is this problem? Here is an alphabetical list of prescription drugs that are currently or have been previously involved in litigation claims:
( ) = the claimed dangerous side effect
5-Alpha Reductase Inhibitor, Accutane (IBD/Colitis), ACE Inhibitors, Acetaminophen, Aciphex, Actavis Recall, Actonel, Actos (Heart Attack), Adderall, Advair, Advanced Medical Optics (AMO) Complete MoisturePlus, Advil, Aldara, Alendronate, Alli, Ambien, Amiodarone, Antiretroviral Prophylaxis, Anzemet, Aptivus, Aranesp, Arava, Aredia, Aricept, Avandia (Heart Attack), Avastin (Eye Infection, Blindness), Avelox (Liver Damage), Avelox (Tendon Rupture), Avodart, Avonex, Azathioprine
Baycol, Bayer Aspirin Supplement Products, Bayer Heart Health Advantage, Benzocaine, Betaseron, Bextra, Bismacine, Bisphosphonates (Esophageal Cancer), Bitter Orange, Bonefos, Boniva, Botox, Byetta (Cancer)
Campath, Cardizem, Celebrex, Celexa, CellCept, Chantix, Childrens Tylenol, Cialis, Cipro, Cleocin, Clomid, Clozaril, Complete MoisturePlus, Concerta, Coreg, Crestor, Cylert, Cymbalta, Cytotec
Darvocet, Darvon, Daypro, Definity and Optison, Depakote (Birth Defects), Depo-Provera (Breast Cancer), Desmopressin, Dexedrine, Dexilant, Didronel, Dietary Supplements (Excessive Copper), Diflucan (Birth Defects), Digitek, Dilantin, Diltiazem, DMAA Dietary Supplement, Dolasetron, Dronedarone, Duragesic Patch, Dutasteride
Effexor, Elidel, Enbrel (Leukemia), Epilepsy Drugs, Epogen, Estratest, Ethex, Ethex Morphine, Evista
Fentora, Finasteride (Erectile Dysfunction, Male Breast Cancer), Fleet Enema, Foradil, Fosamax
Gadolinium, Gardasil, Geodon, Gianvi, Gilenya, Ginko Biloba (False Marketing Claims), Gleevec
Heparin, Herceptin, Hormone Therapy (Prostate Cancer), Humira (Leukemia), Hydrocodone, Hydroxycut (Liver Damage)
Lamictal (Birth Defects, Meningitis), Lariam, Levaquin, Levitra, Levodopa, Lexapro, Listerine, Loryna, Luvox, Lymerix, Lyrica
Macrobid, Macugen, Maxipime, Medtronic Infuse Bone Growth (Cancer), Menactra, Meningitis Vaccine, Mercaptopurin, Metadate, Methazolamide, Methylin, Minocin (Blindness), Mirapex, Mobic, Motrin, Multaq
Natrecor, Neutrontin, Nexium (Bone Fractures), Nitrofurantoin, Novantrone, NovoSeven, Nuva Ring
Omega Alpha Kidney Flush, Omniscan Gadolinium, One A Day Multivitamins, Ortho Evra Patch,
Pacerone, Paxil (Birth Defects), Pfizer Lo/Ovral Birth Control Pill, Plavix (Bleeding, Hemorrhaging), Pradaxa (Traumatic Bleeding), Premarin, Premphase, Prempro, Prevacid, Prilosec, Procrit, Propecia, Propylthiouracil, Proscar, Proton Pump Inhibitors (Birth Defects), Protonix, Protopic, Provigil, Prozac
Raptiva (Progressive Multifocal Leukoencephalopathy PML), Reclast, Reglan, Regranex, Relafen, Remeron, Remicade (Leukemia), Reminyl, Requip, Risperdal, Ritalin, Rituxan, RotaTeq
Serevent, Seroquel (Cardiac Death), Simvastatin and Amiodarone, Sinemet, Skelid, SlimQuick (Liver Failure), Solodyn, Soriatane, Sprycel Leukemia Drug (Pulmonary Arterial Hypertension), SSRI Antidepressants (Birth Defects), Strattera, Symbyax
Tamiflu, Tamoxifen, Tekturna, Terbutaline, Thimerosal, Tiazac, TNF blocker, Topamax (Cleft Birth Defects), Trasylol, Trileptal, Tylenol (Liver Damage)
Xenadrine, Xenical, Xigris, Xolair
Zevalin, Zicam, Zithromax (Sudden Death), Zocor, Zoloft, Zometa, Zyban (Birth Defects),
Zyvox (Serotonin Syndrome)
BE AWARE: The law limits the time you may file a lawsuit if you have been injured by a dangerous drug. Failure to file before this deadline may deny you the right to file suit.