Crestor belongs to a group of drugs called HMG CoA reductase inhibitors, or statins, which lower triglycerides, or types of fat, and cholesterol in the blood. More specifically, these drugs increase the levels of good cholesterol or high-density lipoprotein (HDL) in the blood while simultaneously decreasing the levels of cholesterol or low-density lipoprotein (LDL) in the blood. Elevated levels of LDL in the blood is a known risk factor for life-threatening medical conditions like stroke, heart attack and heart disease. Crestor was approved by the FDA in 2003 and is currently manufactured by AstraZeneca Pharmaceuticals. AstraZeneca introduced Crestor as the newest statin, and marketed the drug as the most powerful of the already potent statins on the market. Unfortunately, this “super-statin” has been associated with significant adverse side effects in recent years, including the onset of acute kidney damage in individuals who take Crestor.
Acute kidney damage is a sudden, rapid loss of kidney function. This type of kidney damage is typically diagnosed by specific criteria, including a short time period, occurring within less than forty-eight hours, and a reduction in kidney function, demonstrated by a rise in serum creatinine and a decrease in urine output.
When the kidneys are damaged, they lose their critical ability to filter excess fluid, electrolytes, and waste materials from the blood, allowing these dangerous substances to accumulate in the body. Common symptoms of acute kidney damage are:
The course of treatment for acute kidney damage depends largely upon determining and treating the underlying disorder, or cause of the damage. The administration of intravenous fluids is commonly the first step in improving kidney function. In the meantime, victims of severe kidney damage are typically advised to avoid substances that are toxic to the kidneys, including certain medications. Renal, or kidney, function will also be observed intensively in order to monitor urine output and serial serum creatinine measurements. In some cases, a urinary catheter may be inserted in order to relieve any bladder outlet obstruction and to monitor the output of urine.
Lack of improvement with typical acute kidney damage treatments may mean that the victim requires artificial support, as in dialysis. In severe cases of acute kidney damage, especially those in which the cause of the damage is not determined, the victim may never regain full kidney function. This condition is called end-stage renal failure and typically calls for lifelong dialysis or a kidney transplant.
Before Crestor was approved by the FDA in 2003, several consumer interest groups urged the agency to deny the drug’s approval. The following year, after the drug was FDA-approved, one of these very groups, called Public Citizen, filed a petition with the FDA to issue a Crestor recall, removing the drug from the market. In 2005, the FDA composed a reply letter to Public Citizen claiming to have found no grounds for a Crestor recall, ultimately denying the petition. According to the FDA, there didn’t seem to be any cause for concern regarding Crestor use, compared to the other statins already on the market. In other words, Crestor may have posed a danger to the public, but no more danger than was associated with other statins. Despite the fact that the FDA claimed to have found no greater potential for harm resulting from Crestor use compared to other statins, the agency did require AstraZeneca to update Crestor’s warning label to include the drug’s potential to cause kidney failure.
In 2001, a drug similar to Crestor, called Baycol, was recalled because of its potential for causing significant harm. Since its removal from the market, over one hundred reports of fatalities have been linked to Baycol, resulting from the development of rhabdomyolysis, a severe condition which causes the destruction of muscle tissue and leads to kidney failure. AtraZeneca originally filed an application with the FDA to market Crestor in 2001, but approval was delayed after Crestor clinical trials were stopped worldwide. Patients involved in the trials who were taking 80mg of the drug daily reported kidney damage and muscle weakness, which is one of the first signs of rhabdomyolysis. Because of these adverse reactions, production of the 80mg dose of Crestor was discontinued, and only 5mg, 10mg, 20mg, and 40mg doses were produced thereafter. The drug was approved just two years later, even though the risk of life-threatening conditions like rhabdomyolysis and acute kidney damage related to the use of Crestor was evident long before.
Clinical trials exposed the connection between Crestor use and severe medical conditions like rhabdomyolysis and acute kidney damage as early as 2001. Unfortunately, the FDA still approved the drug and an estimated 4.5 million people have been prescribed Crestor since. If you or a loved one has suffered from acute kidney damage which you believe to be linked to the use of the statin, Crestor, contact a Crestor attorney for help. You may be entitled to reimbursement for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering incurred by you and your family, which can you collect by filing a Crestor lawsuit against manufacturing company, AstraZeneca. Victims of severe or life-threatening injuries associated with the use of a potentially defective drug are not at fault. The only way to protect your rights, stand up to the pharmaceutical company potentially responsible for your injuries, and collect the compensation you deserve is to contact a qualified Crestor lawyer and file a Crestor lawsuit.