In a move that shocked Merck and Wall Street analysts last week, Merck’s new and long-awaited cholesterol drug—Cordaptive—was rejected by the Food and Drug Administration (FDA).  Some leading heart researchers were not surprised, saying that the FDA is more reticent to approve new drugs in the wake of recent defective drug controversies and accusations the FDA might have approved several which were not fully tested.

“There is a shifting landscape in the medical community,” said Cleveland Clinic cardiologist Steven Nissen.  Nissen’s outspoken criticism factored in painkiller Vioxx and diabetes medicine Avandia being withdrawn from market. 

”When you have a drug that has potentially widespread actions in the body, you would like to characterize its effects before using a drug in a number of patients,” he said. “There is a question if we know enough about a new drug to go forward.” (more…)

The US Justice Department wants to know more about a crucial Vytorin study, the results of which were concealed for more than  a year.  Known as ENHANCE, the study found that Vytorin  was no more effective at preventing clogged arteries than less expensive statin drugs.   The Justice Department probe is just one of many looking into the way ENHANCE was handled.

Vytorin, which was developed and marketed jointly by Merck and Schering-Plough, was approved for use by the Food & Drug Administration (FDA) in 2004. Since it came on the market, Vytorin sales have reached $5 billion per year. Vytorin is a combination of cholesterol-lowering Zetia and the statin Zocor. Statins like Zocor reduce the amount of cholesterol produced by the liver, while Zetia lessens the amount of cholesterol in food that is absorbed in the intestines. High cholesterol levels put a person at risk of developing clogged arteries – a major risk factor for heart attacks and strokes. Doctors and Vytorin users were led to believe that the drug would effectively reduce both sources of cholesterol, thereby lessening the amount of plaque build up in the arteries, as well as the risk of having heart attacks and strokes. (more…)

A prominent consumer advocacy group says Ortho Evra, Johnson & Johnson’s controversial birth control patch, is too dangerous to be on the market.  Public Citizen is asking federal regulators to ban Ortho Evra because it poses a higher risk of potentially fatal blood clots than other hormone-based contraceptives.

When Ortho Evra was introduced in 2002, Johnson & Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those of oral contraceptives. But in 2005, the Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system. However, hormones in Ortho Evra are absorbed directly into the blood stream, which causes a higher concentration of the medication to enter a patient’s body. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. (more…)

Last month, Congress asked the Food and Drug Administration (FDA) to speed its efforts in forcing drug companies to include safety-reporting information in television and radio ads.  Now, Congressional Democrats are placing more pressure on the drug industry’s direct-to-consumer advertising following increased problems over the marketing of several popular drugs, including Vytorin, Lipitor, and Procrit.

Last year, Democrats lost a fight to increase government regulation of TV commercials for prescription drugs; however, recent controversies have helped Democrats on the House Energy and Commerce Committee.  Also, late last month, drug maker AstraZeneca Plc urged U.S. lawmakers to revive a program for drug makers who want to voluntarily submit their television commercials for regulatory review.  Congress created the program last year but it has not taken effect and lawmakers failed to give the FDA full authority to collect and spend industry fees to fund reviews.  Because the system is voluntary, FDA scientists are concerned it misses most adverse drug reactions. (more…)

Medtronic Inc. is recalling some medical devices because they may be coated with tainted heparin, a drug linked to 81 deaths in the US. The disposable medical devices, used during cardiac bypass surgery, are made with Medtronic’s Carmeda BioActive surface, which includes heparin. No injuries have been reported in relation to the Medtronic devices, but the recall underscores the enormous scope of the problems involving contaminated heparin.

Tainted heparin first garnered attention earlier this year, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in 11 other countries, including Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 81 to be exact - were associated with contaminated batches of heparin. (more…)

Health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking - despite the drug’s association to suicidal thoughts and behavior.  New smoking cessation guidelines, published by the US Public Health Service, do note that Chantix has been linked with suicide and other psychiatric side effects.  But they promote the Pfizer drug as the method most likely to help smokers wanting to quit.  The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also due to the fact that their lead author,  Dr. Michael Fiore, has ties to Pfizer.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. (more…)

Suicide is common in the US, representing the fourth leading cause of death for those aged 18 to 65 and the third leading cause for those aged 15 to 24.  Add to those figures the complexity of medications.  In recent years, disturbing reports have suggested that  side effects of some popular drugs - such as Chantix, Accutane, Singular and Paxil - include suicidal thoughts and behavior.

Reports have been filed with drug makers and the Food and Drug Administration (FDA) on at least six drugs or drug classes that may be linked to suicide or suicidal thoughts.  Recently, the FDA released notices about several such medications including Singlulair; Epilepsy drugs including carbamazepine, gabapentin, felbamate, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, and valproate; and the smoking-cessation drug Chantix.  Reports have been filed on SSRI antidepressants including Paxil and Prozac, the influenza drug Tamiflu, and the acne medicine Accutane.   “The brain is a complex organ, and most of the drugs are complex as well,’’ says Dr. Thomas Laughren, head of the division of psychiatric products at the FDA.  “It’s not unreasonable to think that a drug that gets into the brain may have effects other than you hope they would.’’ (more…)

A scientist who helped Merck & Co. conduct clinical trials for the cervical cancer vaccine Gardasil is questioning efforts to mandate the controversial vaccine for young girls, whether their parents want them to have it or not. Dr. Diane Harper, a top expert on the Human Papillomavirus (HPV), says Merck’s aggressive campaign to convince states to adopt mandatory Gardasil vaccine guidelines enters into a “real danger zone.”

Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers. (more…)

Cephalon Inc’s quest to expand the approved uses of the narcotic painkiller Fentora hit a snag yesterday, as a Food & Drug Administration (FDA) panel voted 17-3 against the proposal. Panel members said they were concerned that expanding the use of Fentora beyond cancer patients would lead to more misuse of the highly-addictive drug, which has already been blamed for many overdose deaths. Currently, about 20,000 people use Fentora, but some expect that with expanded approval, that number would balloon to ten million.

Fentora was approved in 2006 only for treating pain in cancer patients. It is intended for patients who experience breakthrough pain because they have developed tolerances to other opiate painkillers. Fentora contains fentanyl, a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose. (more…)

Two separate reports written by researchers at Wake Forest University School of Medicine support findings released recently concerning anticholinergic medications like Aricept, Zantac and Detrol.  The studies found that anticholinergic drugs may be adversely affecting the thinking skills of older patients, a phenomenon not observed in those patients studied who do not take these medications.  The studies also indicate that anticholinergics may cause older patients to experience a decrease in their daily physical activities.

Anticholinergic drugs are a commonly prescribed group of drugs prescribed for the treatment of a variety of diseases and conditions, including acid reflux, Parkinson’s Disease, and urinary incontinence. Anticholinergic drugs work by stopping acetylcholine—a chemical that enhances communication between nerve cells in the brain—from binding to its receptors in nerve cells. (more…)