A February 2012 U.S. Food and Drug Administration (FDA) drug safety communication warned that the anti-cholesterol drug rosuvastatin calcium—sold under the brand name Crestor—might cause kidney damage, liver damage, rhabdomyolysis, type 2 diabetes, and memory loss.
What Is Crestor? When Is It Prescribed?
Crestor is a brand name for the drug rosuvastatin calcium. Made and sold by the British pharmaceutical company AstraZeneca, Plc, this prescription medication is used to treat high cholesterol. The FDA approved Crestor in 2003 after the Japanese pharmaceutical company Shionogi KK first developed it. Since then, it has been available in 5mg to 40mg oral tablets.
Like other statin-class drugs, Crestor prevents the enzyme HMG-CoA reductase from creating low density lipids (LDLs) in the liver. LDLs are the type of cholesterol that block arteries, so inhibiting their production reduces users’ risks of developing heart disease. Statins are among the most commonly prescribed heart medications in the United States; in 2008 alone, consumers spent $14.5 billion on statins.
Potential Side Effects Are Numerous and Serious
Even before it approved Crestor, the FDA expressed concerns over the drug’s tendency to cause kidney damage, a side effect absent in other statin drugs. In October 2004, consumer advocates from an organization called Public Citizen produced studies showing that 29 Crestor users suffered kidney damage and that Crestor is 75 times more likely than other statin-class drugs to cause kidney problems. Public Citizen documented 6.4 cases of kidney damage per million filled prescriptions of Crestor.
The FDA also determined that Crestor has been associated with liver injury in rare instances. Symptoms of Crestor liver injury include:
- unusual fatigue
- loss of appetite
- right upper abdominal discomfort
- dark urine
- yellowing of the skin or whites of the eyes
In 2005, the FDA issued a Crestor warning because it can cause rhabdomyolysis, a condition characterized by atrophying skeletal muscle tissue. The lost muscle mass (myoglobin) collects in patients’ blood and can cause severe kidney problems and even death. Most of the time, this disease is caused by severe injury such as a muscle being crushed by a heavy object, and in other cases it arises due to extreme alcohol abuse. Primary symptoms include:
The broken-down muscle mass can cause other problems throughout the body such as:
- electrolytic disturbances
- cardiac arrhythmia
- dark urine
- oligura or anuria (decreased or non-existent urine production, respectively)
- internal blood clotting
Treatment includes rapid rehydration, as most cases of rhabdomyolysis are caused by severe accidents. Doctors may also prescribe various drugs to cause myoglobin to disintegrate. In extreme cases, they’ll put patients on dialysis.
Later, in March 2012, the FDA warned the public that Crestor use combined with certain other drugs, namely “protease inhibitors” meant to treat HIV and hepatitis C, can raise the amount of Crestor in users’ blood, which can cause muscle damage. The FDA contraindicates using Crestor with these drugs.
Type 2 Diabetes
On January 9, 2012, the medical journal Archives of Internal Medicine published a study analyzing a possible association between statin use in women and type 2 diabetes. The researchers investigated 161,808 women between the ages of 50 and 79 years old who participated in the Women’s Health Initiative over the course of several years. They found that women who took drugs belonging to the statin class were 48 percent more likely to develop type 2 diabetes than women who did not. The researchers concluded that “statin use is associated with an increased risk for [type 2 diabetes].”
In February 2012, the FDA changed simvastatin’s drug label to reflect the increased risk.
Also in the February 2012 update, the FDA informed the public that it was investigating reports of Crestor memory loss that occurred to users who had been on the drug for several years. Symptoms arose in every age group, though more often in patients over the age of 50. Examples are:
- memory loss
- “fuzzy” or unfocused thinking
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Crestor lawsuit on your behalf if necessary.
If you have taken Crestor and believe it harmed you, contact RLG today.