
According to last nights news, Avandia, a drug used in the treatment of type 2 diabetes has been found to cause an increase risk of heart problems. I don't know about anyone else but I'm questioning whether the medical profession, and the average patient should be relying on drugs to control our many health problems. There is ostensibly a stringent procedure that must be followed by drug companies to gain approval for the marketing of new drugs. It takes years of testing that is supposed to provide the FDA with sufficient information to judge the safety of any medication that is being submitted for approval.
FDA officials acknowledged that Glaxo Smith Kline submitted information last August indicating some increased risk from the drug but that other studies were contradictory. Excuse me, but this company settled a large lawsuit with NY State regarding the data it releases on the safety and effectiveness of it's drugs. The suit specifically claimed that Glaxo fraudulently withholds study results that question the safety of it's drugs. The suit was settled for 2.5 million dollars. Does a drug company not guilty of the charges settle lawsuits for that large a sum of money?
I found 14 different drugs have been recalled in the last 10 years. Even factoring in long term usage and improper usage by patients I find this list to be disconcerting. My Mom took 2 of the drugs on this list and developed a heart problem. Of course she might have developed it anyways because of the general state of her health. Is that part of the problem as well? Are these problems things that would have happened anyway in these patients if they weren't taking these drugs? Are we doing the right thing by relying on a drug to fix what a lifestyle change would take care of?
It looks to me as if the FDA needs to overhaul it's approval system. I'm not hearing that they have done so. At no time in the last 10 years, with 14 drugs removed from the market are they saying "Hold on a minute, we need to look at this". If the FDA won't hold the drug companies accountable then we're going to have to. Maybe instead of taking a pill to fix our problems we need to really knuckle down and make lifestyle changes? That's NOT an easy solution, but with so many problems with drug recalls and conflicting reports about drug safety, it might be our safest choice.
Drug companies are in the business of creating profits for their shareholders. I'm going to write a letter to my Congressman and tell him that I'd like to keep breathing, maybe he should look in to the FDA situation and see if the problem isn't one that's fixable. In the meantime, I don't think I'll take any drugs. Not until I'm comfortable with the safety of the drug I'm taking.
Drug Recalls
Baycol®: Originally approved by the FDA in 1997 for use as an anti-cholesterol drug, Baycol® was removed from the market in 2001 due to the serious dangers it presented to patients. Baycol® has been found to cause rhabdomyolysis, a condition that leads to a breakdown of muscle cells and allows its contents to be released into the blood. Rhabdomyolysis can result in pain and muscle weakness. As the kidneys fail, it can also cause paralysis and wrongful death.
Bextra®: Also known as valdecoxib, Bextra® is used to abate the pain, tenderness, swelling, and stiffness resulting from arthritis, and for the treatment of menstrual cramps. Bextra® is part of a non-steroidal anti-inflammatory class of drugs that includes Vioxx and Celebrex, called COX-2 inhibitors. These drugs were intended to prevent the gastrointestinal problems caused by other arthritis medications. However, there is evidence that other COX-2 inhibitors are dangerous for the heart, leading to serious concerns about the safety of Bextra®. In 2002, reports of serious or life-threatening hypersensitivity and skin reactions in Bextra® users prompted the FDA to issue a safety alert and changes to the product labeling, warning patients of such side effects.
Duract™: Previously used as a short-term pain relief medication, Duract™ was recalled in 1998 after serious liver damage was found to be associated with the drug. Because of the dangers that Duract™ could pose to the liver, the drug was approved for use, but not to exceed 10 days. However, some patients and doctors did not follow proper instructions for Duract™ use, leading to cases of severe liver damage, including liver failure and wrongful death .
Fen-Phen: Before the drug was recalled by the FDA due to dangers, Fen-Phen was used by millions of Americans as a weight loss drug. In 1997, the drug was with drawn from the market following evidence that Fen-Phen use was linked to incidences of heart valve defects and primary pulmonary hypertension.
Hismanal®: Originally used as an antihistamine in a number of allergy and hay fever drugs, the dangers that Hismanal® presented to patients prompted a change to the warning label of the drug soon after its approval by the FDA. Hismanal® was recalled after the manufacturer of the drug, Janssen Pharmaceutica, decided the serious and sometimes life threatening side effects resulting from the medication were too risky for patients. The use of Hismanal® in conjunction with certain foods, drugs, or medical conditions increased the instances of cardiac problems. Because Hismanal® was an over-the-counter drug, many patients were unaware of the serious dangers the medication could pose to their health. If you or a loved one has suffered harm or wrongful death because of a dangerous drug that was on the market, choosing a skilled medical malpractice attorney from our directory can help you move forward with your case.
Posicor®: Posicor® was originally manufactured for the treatment of high blood pressure and chest pain. Following reports of adverse reactions to Posicor®, the FDA revised the labeling of the drug and added two drugs to the list of medications that should not be used while taking Posicor®. However, dangerous side effects related to Posicor® use continued, and it was soon removed from the market because of the heart problems associated with the drug, including arrhythmias and low blood pressure.
PPA: PPA, or phenylpropanolamine hydrochloride, is an ingredient that can be found in several over-the-counter cough and cold medications, as well as in weight loss products. Studies conducted in the past few years have found an increased risk of hemorrhagic stroke and bleeding of the brain in patients taking PPA. The FDA has issued warnings regarding the dangers of PPA, however, the chemical is available over-the-counter and can still cause adverse reactions in patients. Those that have sustained an injury or are victims of wrongful death because of a defective drug, contact a medical malpractice lawyer for legal assistance.
Propulsid®: Propulsid® is a prescription medication used for the relief of nighttime heartburn for patients with gastroesophageal reflux disease that hasn't responded to other treatments. The manufacturer of the drug removed it from the market in 2000 following heart rhythm abnormalities and cases of wrongful death in patients taking Propulsid®. The label of Propulsid® had been changed several times prior to the recall to warn patients of dangerous side effects, however, the dangerous side effects associated with the drug continued.
Raxar™: Raxar™, an oral flouroquinolone antibiotic, was voluntarily withdrawn from the market in 1999 because of adverse side effects and the availability of safer treatments. The benefits of the drug were found to be outweighed by the risk of cardiovascular problems connected to Raxar™ use.
Rezulin®: Originally intended for use as a drug to treat Type 2 diabetes, the FDA ordered the maker of Rezulin® to withdraw the medication amidst findings that it posed serious dangers to patients. Since 1997, Rezulin® has been linked to reports of liver toxicity, and although the warning label underwent revisions, the availability of safer drugs in conjunction with the dangers of Rezulin® prompted its removal from the market. Victims of injury and wrongful death resulting from dangerous drugs can choose a medical malpractice attorney who is well versed in pharmaceutical litigation for legal counsel.
RotaShield™: The manufacturer of the RotaShield™ vaccine, Wyeth Laborities, halted distribution of RotaShield™ in 1999 until further data on the alleged connection between the vaccine and intussusception became available.
Seldane®: Seldane®, a terfenadine-containing antihistamine, was used for the treatment of allergies until these products were linked to serious heart problems when used in conjunction with certain drugs, including some antibiotics and antifungal medications. In light of these problems, the manufacturer of Seldane® and the generic form of terfenadine ceased U.S. marketing and distribution of these products. Choose from our directory of medical malpractice lawyers to help you determine if you have a viable wrongful death or medical malpractice case.
Thimerosal: Used in some medications and vaccines as a preservative to kill bacteria, the high amount of mercury that is toxic in thimerosal has led many to believe that it can cause serious harm to patients. In large doses, mercury has been known to result in birth defects, renal failure, as well as damage to the immune system and brain. Some believe thimerosal can cause mercury poisoning and autism in babies and children.
Vioxx®: Originally intended for the relief of pain and inflammation resulting from arthritis and menstrual cramps, Vioxx® is in a class of drugs called COX-2 inhibitors. Recent studies have shown that long-term Vioxx® use can increase the risk of cardiovascular problems, including heart attack and stroke, which could result in wrongful death. This prompted the voluntary recall by it's manufacturer, Merck.