The FDA recently announced that it was aware that patients taking new, experimental drugs to treat high cholesterol were suffering adverse cognitive events. The new drugs, developed by Sanofi and Regeneron, are known as PCSK9 inhibitors. Cholesterol drug lawyers at Pintas & Mullins Law Firm explain the potential side effects among these and other cholesterol-lowering drugs.
Both Pfizer and Amgen are also currently developing PCSK9 inhibitor medications, which investors are watching very closely and with high expectations. An estimated one in six adults, or about 17% of the population, has high cholesterol according to the CDC. This condition is a major factor in the development of heart disease and diabetes, and many patients need medications to maintain normal cholesterol levels in addition to diet and lifestyle changes.
The most popular class of cholesterol-lowering drugs is known as statins, and includes drugs like Crestor, Lipitor, and Zocor. These medications block the liver’s ability to produce LDL, or “bad” cholesterol and are prescribed to about 20 million Americans.
Similarly, PCSK9 drugs block the protein that maintains the presence of LDL cholesterol in the blood. In the most recent clinical trials, the FDA observed adverse neurocognitive side effects, such asmemory loss and confusion, in patients. As a result, the agency has requested that Sanofi and Regeneron consider including neurocognitive tests in at least one group of patients.
Statins are also linked to adverse neurological side effects, including Lou Gehrig’s disease, though for statin patients memory loss may be the least of their worries. Statins, particularly in high doses, are associated with extensive liver damage, muscle damage (rhabdomyolysis) and type 2 diabetes.
The FDA recently required all statin drugs to include the risk of increased blood sugar and type 2 diabetes, specifically among women. The side effects associated with cholesterol drugs have become increasingly serious, with patients losing their jobs due to memory loss and confusion, and being diagnosed with diabetes despite lifestyle changes.
It is important for patients to realize that once you decide to begin a medication to help lower your cholesterol, you will likely have to stay on it indefinitely. The only exception is in patients taking significant measures to change their diet and lifestyle. Factors that contribute to high cholesterol and can be changed through will alone include:
- A diet high in fat, salt and of course, LDL cholesterol
- Lack of exercising (about 30 minutes per day)
- Heavy alcohol use
- Stress and anger management
- Being overweight or obese
The FDA has been criticized in the past for failing to warn patients and
physicians early enough about the risks of drugs. It seems that they are
increasing the effort to be as transparent as possible and make the public
aware of possible side effects. The warnings regarding PCSK9 drugs are
part of the FDA’s oversight of new drug development.
There is currently massive litigation against statin drug manufacturers over their risk of causing development of type 2 diabetes. In April 2013 all Lipitor diabetes lawsuits were consolidated before one judge in multi-litigation (MDL) in South Carolina.
Our team of Lipitor and Crestor lawyers is currently representing clients diagnosed with type 2 diabetes after being prescribed a statin. We offer free legal evaluations to injured patients nationwide. If you or someone you love was diagnosed with diabetes after taking a statin, contact our firm today to see if you can recover compensation for the harm done to you.