FDA Posts List of Potentially Dangerous Prescription Drugs
Monday, September 08, 2008
The U.S. Food and Drug Administration has for the first time posted on its website a list of potentially unsafe prescription drugs – a move officials said is designed to help consumers and physicians better keep track of drugs currently being reviewed for complications. Each of the 20 drugs now on the list is being further evaluated by the FDA for a variety of potentially life-threatening safety problems, side effects, and complications.
The list, released as part of the agency’s Adverse Event Reporting System (AERS), will be updated four times each year, officials said. The list of potentially dangerous prescription pharmaceuticals, as well as more information on the FDA’s policy on reporting adverse drug reactions, can be viewed here.
FDA officials cautioned that the prescription drugs on the list are not necessarily dangerous and advised that patients currently prescribed the drugs should continue taking them until their physicians instruct otherwise. However, some of the drugs on the list have well-documented and serious side effects resulting in thousands of deaths and injuries.
The potentially dangerous prescription drugs listed on the FDA website include:
Heparin
Heparin, a popular drug-thinner, has been blamed for hundreds of deaths and serious injuries across the United States. The injuries and deaths were caused by severe allergic reactions to the drug. In early 2008, the FDA announced that the adverse reactions were likely caused by the Chinese manufacturer of the drug, which had used a counterfeit active ingredient in heparin.
Heparin, which is commonly used to prevent blood clotting during surgeries and dialysis treatments, was recalled in February 2008.
In addition to the counterfeit active ingredient, heparin also has been criticized for product labeling that fails to adequately differentiate between 1,000-unit bottles and 10,000-unit bottles of Heparin, which has led to deaths and severe overdose injuries in newborns who were mistakenly given the stronger doses by nurses.
Cymbalta
The anti-depression drug Cymbalta (generic: duloxetine hydrochloride) has been linked to worsened liver disease, liver complications, and urinary retention problems in patients. Cymbalta earned FDA approval in August 2004 for the treatment of certain major depressive disorders, fibromyalgia, and nerve pain associated with diabetes (diabetic peripheral neuropathy). More than an estimated one million people are currently taking the drug.
In October 2005, the FDA ordered new warnings for the labeling of Cymbalta and cautioned physicians about prescribing the drug to patients with preexisting liver disease or a history of alcohol use. The FDA is now looking further into the complications associated with the drug.
Dilantin
Dilantin (generic: phenytoinis), a prescription drug used to treat epileptic seizures, has been shown to cause a potentially deadly skin reaction called Stevens-Johnson Syndrome. The disease most often causes rash, blisters, open sores, skin peeling, and painful sores in the skin around the eyes, mouth, and genitals. It is fatal in about 15 percent of cases.
Dilantin was approved by the FDA in 2001. It has also been linked to severe side effects including bone loss and bone fractures, hallucinations, slurred speech, vision problems, low blood pressure, and slow or irregular heartbeats
Seroquel
Seroquel is commonly prescribed to treat schizophrenia and bipolar disorder (manic depression), but an overdose of the drug can be deadly. The exact amount of Seroquel needed to overdose depends on a number of factors, including how much of the drug was taken and whether it was taken with any other medicines, drugs, and/or alcohol.
The FDA is now looking into whether the packaging on sample packs of Seroquel has led to confusion among patients and physicians about the proper doses of the drug, causing accidental overdoses.
In 2004, Seroquel was identified as one of six anti-psychotic drugs that promote diabetes, obesity and high cholesterol. As a result, physicians are now cautioned to carefully screen patients for histories of obesity and diabetes as well as weight, blood pressure, and cholesterol levels. Therefore, people with a propensity for developing these serious diseases and conditions should avoid taking Seroquel.
Oxycontin
The pain killer Oxycontin is a powerful opiate designed to help manage pain in cancer patients and other chronic pain sufferers. In the wrong hands, the highly addictive drug is prone to misuse, abuse and overdose, according to the FDA. Oxycontin is designed as a time-release tablet, but some addicts break open the tablets to release an intense, deep, and addictive sedative. Oxycontin-related crimes and addiction have skyrocketed in the past 10 years.
With so many reports of Oxycontin abuse and addiction, the FDA now is looking into whether Oxycontin should face tighter regulations to keep the drug in the hands of only those patients who need it.
Tysabri
Tysabri is commonly prescribed to treat symptoms of multiple sclerosis, but the drug has been linked to several serious side effects and complications, including liver damage, a fatal brain infection called progressive multifocal leukoencephalopathy (PML), and the formation of melanoma, a dangerous and fast-moving type of skin cancer. The FDA listed the increased risk of melanoma as the reason the drug is currently being further investigated.
In February 2008, the New England Journal of Medicine published a letter detailing the cases of two multiple sclerosis patients who developed melanoma shortly after beginning Tysabri treatments.
Posted under: Dangerous Drugs • Heparin • Oxycontin • Seroquel • Trasylol • Tysabri