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statin 11 articles

Regeneron, Sanofi pay $67.5 million to expedite approval of experimental cholesterol drug

Regeneron Pharmaceuticals and Sanofi are paying $67.5 million to improve the chances of getting their experimental cholesterol-lowering drug on the market before any other drug company with similar cholesterol treatments in development. Regeneron and Sanofi are purchasing a first-of-its-kind voucher that grants expedited review by drug regulators, paving the way for faster Food and Drug Administration (FDA) approval. The voucher was awarded to BioMarin Pharmaceuticals as an incentive for drug companies to invest in drugs for rare childhood diseases. It allows the drug company expedited review of a different drug of its choice. Companies given vouchers can also sell them ... Read More

Lipitor side effects lawsuits mount against Pfizer

Lawsuits are mounting against Pfizer Inc., alleging the company withheld information that its cholesterol-lowering statin drug Lipitor could cause women to develop type 2 diabetes. In the past five months, Lipitor side effects lawsuits have jumped from 56 to more than 1,000. With the number of lawsuits growing so quickly, the federal judicial panel consolidated all Lipitor lawsuits in Charleston, S.C. Pfizer fought the decision, claiming that it might cause more people to file lawsuits against the company. Lipitor is the best-selling prescription drug in the world, generating more than $130 billion in sales since it hit the market in 1996. ... Read More

Doctor’s Best Red Yeast Rice pills contain undeclared statin medication

Doctor’s Best is recalling more than 7,000 bottles of its Red Yeast Rice dietary supplement, used to “naturally” lower cholesterol levels, because the product was found to contain lovastatin, the active ingredient in the brand-name cholesterol-lowering drugs Altoprev and Mevacor, which are known as statins. Doctor’s Best’s Red Yeast Rice dietary supplements are not authorized by law to contain regulated active drug ingredients, and the supplement’s label does not disclose that this ingredient is in the supplement. Consumers who use these supplements found to contain lovastatin in rare cases could experience statin side effects, which include muscle injury, liver damage, ... Read More

Another Lipitor side effects lawsuit filed against Pfizer

Another lawsuit has been filed against Pfizer by a woman claiming the pharmaceutical company’s cholesterol-lowering drug Lipitor caused her to develop type 2 diabetes, and that the company failed to warn doctors and consumers of this risk. Jodie Ward is the first person to file such a lawsuit in the U.S. District Court in Nebraska, however several similar cases have been filed elsewhere and many have been consolidated into a multidistrict litigation in South Carolina. In August 2011, the Food and Drug Administration (FDA) ordered Pfizer to change the safety label on Lipitor based on studies that showed the drug ... Read More

Woman files lawsuit claiming Pfizer’s Lipitor caused her to develop type 2 diabetes

Gladys Board didn’t know when she started taking Pfizer’s cholesterol-lowering statin medication Lipitor in the late 1990s that it could increase her blood sugar levels and put her at risk for developing type 2 diabetes. Pfizer did not alert anyone of this risk until 2011, after the Food and Drug Administration (FDA) ordered the company to place a warning on its safety label. The FDA’s action was based on studies that showed the widely prescribed Lipitor could increase blood sugar levels and put users at risk for developing type 2 diabetes. Those at greatest risk were postmenopausal women, especially those ... Read More

Lipitor may protect against gum disease but increases blood sugar levels

A high dose of the widely prescribed cholesterol-lowering statin atorvastatin, known by the brand name Lipitor, may help alleviate periodontal disease, a small, randomized study suggests. However, other studies have shown Lipitor puts users at risk for type 2 diabetes, a condition that if not properly controlled can lead to gum disease. Periodontal disease is a gum disease that affects nearly half of U.S. adults. It has been associated with atherosclerosis, or hardening of the arteries in some studies although more recent studies have questioned the connection. The possible connection between atherosclerosis and gum disease comes from the type of ... Read More

Merck seeks approval for previously rejected combination cholesterol drug

Merck & Co. is resubmitting the drug application for its combination cholesterol-lower drug MK-0653C, which was rejected by the Food and Drug Administration (FDA) last March due to insufficient data. The experimental medication combines a generic version of the cholesterol-lowering drug Lipitor, the top-selling medication of all time, with Merck’s cholesterol med Zetia. Lipitor and Zetia work in different ways to reduce high cholesterol and thus reduce the risk of heart attack and stroke. Lipitor, also known as atorvastatin, is a member of the statin drug family, which reduce the amount of cholesterol naturally produced in the liver. Zetia reduces the ... Read More

FDA rejects Merck’s new combo cholesterol drug

Merck & Co. will have to provide more data on its experimental cholesterol-lowering drug cocktail before the Food and Drug Administration (FDA) will allow it to be sold in the United States. The drug, known only as MK-0653C, is designed to fight high cholesterol in two different ways to reduce the risk of heart attack and stroke. Merck’s new drug contains a generic version of the statin Lipitor, the top selling drug of all time. Known chemically as atorvastatin, Lipitor works to reduce the amount of cholesterol naturally produced in the liver. MK-0653C also contains Zetia, known as simvastatin, a ... Read More

FDA warns doctors not to prescribe high doses of Zocor, Vytorin

The Food and Drug Administration (FDA) is advising doctors to use caution when prescribing 80 mg doses of the cholesterol-lowering drug simvastatin, known by the brand name Zocor, because of the risk for muscle injury. Simvastatin is also used in combination with other drugs in Vytorin and Simcor. The 80 mg dose is the highest approved dose available for the drug. The FDA says that this dose should only be used by patients who have been taking it for 12 months or longer without any problems. Doctors who find that their patients taking 40 mg of simvastatin are not meeting ... Read More

FDA says it finds no Vytorin-cancer link, but unsure

The U.S. Food and Drug Administration announced today that it found no clear link between Merck’s blockbuster cholesterol drug Vytorin and increased risk of cancer, but it could not rule out the possibility that such a link exists. The agency reviewed data from three Vytorin trials, including the controversial SEAS trial results, which Merck had withheld from the public for 18 months as it aggressively marketed the drug. The SEAS study sought to test Vytorin’s effectiveness as an alternative to surgery in reducing arterial clogging caused by high cholesterol. The results, which were announced in a July 2008 press conference, ... Read More