Tagged Articles

Vytorin 26 articles

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 warns of link between cholesterol drug, muscle injury

More bad news for the cholesterol-lowering drug Vytorin. The drug has been under scrutiny lately for everything from elevated cancer risk and serious side effects to ineffectiveness. This week, the Food and Drug Administration (FDA) issued a safety announcement about simvastatin, one of the two active ingredients found in the medication, and an increased risk of a potentially life-threatening muscle injury. Vytorin combines simvastatin (sold as in individual ingredient under the brand name Zocor) and ezetimibe (also known as Zetia) to reduce the production of “bad” cholesterol. An FDA review of data from clinical studies, adverse event reports, and prescription ... Read More

High doses of cholesterol-lowering drug linked to risk of muscle injury

People who take the highest dose of a cholesterol-lowering medication simvastatin are at an increased risk of muscle injury, according to the Food and Drug Administration (FDA). The agency made the announcement following a review of data from a large clinical trial as well as other sources. Simvastatin is sold as a single-ingredient generic medication, under the brand-name Zocor, and in combination with esetimibe as Vytorin, and niacin as Simcor. The data came partially from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) clinical trial. Other data came from other clinical trials, observational studies, adverse ... 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

New study shows vytorin and zetia less effective than niacin

Vytorin has struck out again, this time in a clinical trial that compared the drug’s safety and efficacy to a prescription form of the B vitamin niacin. The results of the trial, which the New England Journal of Medicine featured in an article and two editorials, were presented Sunday at an American Heart Association meeting and showed that in a direct comparison, niacin worked significantly better than Vytorin and Zetia in reducing arterial blockages. According to a report in NPR, “This study is the third to question whether ezetimibe drugs do what they’re supposed to.” If lowering LDL or “bad” ... Read More

Merck and Schering pay $41.5 million to settle NJ lawsuits

Merck and Schering-Plough, the pharmaceutical giants whose joint venture produced the blockbuster cholesterol drug Vytorin, agreed to pay $41.5 million to settle 140-plus New Jersey lawsuits lodged against the manufacturers for misleading and improper marketing of the drug and for withholding the results of a clinical trial that showed Vytorin to be a dud. The Enhance study revealed that the pairing of Schering-Plough’s Zetia and Merck’s Zocor, which constitutes Vytorin, to be no more effective and possibly even less effective than Zocor alone or other much cheaper, generic statins in treating arterial plaque. But more than the disappointing results, there was ... Read More

Vytorin No. 3 on list of Top 10 medical stories of 2008

Vytorin has come in at the No. 3 spot on a list of the Top 10 Medical Stories of 2008 – and not in a good way. Dr. Kate Scannell, columnist for the Contra Costa Times, which serves the California Bay Area, listed the drug under the header “statin madness.” Dr. Scannell said the drug made her list as a result of two studies that revealed Vytorin, which is a combination of simvastatin (Zocor) and ezetimibe (Zetia), did not reduce artery-clogging plaque buildup, although tests showed it reduced “bad” cholesterol levels. However, she said Vytorin’s bad year wasn’t all bad ... Read More

Vytorin illustrates the problems of direct-to-consumer advertising

Remember those Vytorin commercials with the split screen, comparing people to food? Aunt Barbara on the left and some tacos on the right? Mildly entertaining though they were, those ads underscore a big problem with the promotion of new pharmaceuticals. Evidence suggests that Vytorin’s manufacturers, Merck and Schering-Plough, promoted and sold the anti-cholesterol drug for nearly 2 years despite known clinical trial results that strongly suggested Vytorin to be no more effective than cheap, generic statin drugs. Now Congress is investigating the promotion of Vytorin as lawsuits against its makers pile up in state and federal courts. But Vytorin isn’t ... Read More