The Food and Drug Administration recently issued a warning letter to HBB LLC, the maker of Lazy Larry relaxation brownies, citing that the melatonin used in its product has not been deemed as a safe food additive. Furthermore, the FDA says it can seize the company’s brownies, should HBB continue to make and sell them.

Melatonin is a naturally occurring hormone in the human body and aids in sleep regulation. Melatonin supplements are only lightly regulated by the FDA, and therefore, the makers of melatonin-containing products claim they are not subject to regulatory agency approval, unless their products contain a brand-new ingredient.

Up until last month, Lazy Larry brownies were marketed and sold as, “Lazy Cakes,” but the name was changed in order to further establish the product as a supplement and to appease its critics. However, the FDA’s warning letter indicates the agency is not completely satisfied with simply name change for the product.

Large quantities of melatonin can cause the body’s central nervous system to slow and ultimately lead to breathing problems. Generally, however, melatonin causes people to become extremely tired and slightly nauseous.

McNeil Consumer Healthcare, a division of pharmaceutical company, Johnson & Johnson, announced this week that the company is reducing the maximum daily dose for its Extra Strength Tylenol product. The adjustment is being made in order to decrease the risk of accidental overdose from the drug’s active ingredient, acetaminophen. An overdose of acetaminophen is the top cause of liver failure, and beginning this fall, the label and packaging for Extra Strength Tylenol will now list the maximum daily dose as six pills or a total of 3,000 milligrams.

The changes to Extra Strength Tylenol, a product in short supply these days due to several recalls, will affect products sold in the United States. According to McNeil, acetaminophen is used in more than 600 over-the-counter and prescription medications, which includes commonly used pain relievers and fever reducers like NyQuil, Sudafed and Percocet. McNeil is hopeful that a reduction in the maximum daily dosage will ultimately help consumers use the drug safely. Starting in 2012, the company plans to also reduce the maximum daily dose for its Regular Strength Tylenol product, as well as other acetaminophen-containing pain relievers.

The changes implemented by J&J follow a recent request made by the FDA, in which the agency asked companies that manufacture products with acetaminophen to limit the amount used to 325mg per pill and place a boxed warning on all packaging. The FDA’s push for change was based on their efforts to reduce the risk of liver damage in patients taking the drug. Acetaminophen is one of the most widely used pain killers in the United States, with more than 50 million Americans taking the drug each week.

Following two inspections, an internal investigation and a third-party audit, the U.S. Food and Drug Administration confirmed this week that contractor, Cetero Research, has been faking documents and manipulating samples.

Cetero Research conducts early phase clinical research and bioanalytics for several drug manufacturers, all of whom are then able to use any reported results as supporting evidence when seeking drug approval from the FDA. The investigation into the business practices of a Cetero facility in Houston uncovered that the company was engaging in “significant instances of misconduct and violations.”

In fact, according to the FDA, “The pattern of misconduct was serious enough to raise concerns about the integrity of data Cetero generated during the five-year time frame.” The regulatory agency warned drug makers who used Cetero’s services may have to repeat or confirm any studies conducted by the research company between April 2005 and June 2010.

The mining of a federal database has revealed a potentially harmful interaction between two very commonly used drugs, a discovery which could impact upwards of one million people in the United States. According to a recent article in the Journal of the American Medical Association, Stanford University biomedical informatics graduate student, Nicholas Tatonetti, led a study that found an interaction between the antidepressant, Paxil and the cholesterol-lowering medication, Pravachol, that could potentially put patients at risk for developing diabetes.

Tatonetti and a team of researchers discovered this interaction by applying a specially developed algorithm to the FDA’s Adverse Event Reporting System, which allowed them to analyze “latent signals” to detect diabetes-related side effects. Dr. Tatonetti said in the JAMA article, “This is especially important in the case of drug-drug interactions where the effect may not appear until a very large cohort of patients has been exposed.” The ever-increasing use of electronic medical records could make it easier to identify such adverse drug effects going forward. Moreover, Dr. Tatonetti expressed an optimistic outlook regarding this new strategy for identifying other potentially dangerous drug interactions.

The FDA recently updated healthcare professionals and patients about its ongoing review of the use of oral bisphosphonate drugs and their link to an increased risk for esophageal cancer. The agency has not concluded that taking an oral bisphosphonate will, in fact, increase the risk for cancer but announced that it will continue to evaluate all available data regarding the safety and effectiveness of bisphosphonate drugs, updated the public accordingly.

Bisphosphonates are often used for the prevention and treatment of osteoporosis and bone diseases like Paget’s disease. The FDA issued its warning following reports that esophagitis and esophageal problems occurred in patients who did not follow the proper directions for use of oral bisphosphonates. Some examples of oral bisphosphonates include: Fosamax, Actonel, Boniva, Atelvia, Didronel and Skelid.

Patients currently taking oral bisphosphonates should contact their healthcare professional and discuss the risk and benefits associated with taking the medication. Patients taking the drugs who experience difficulty swallowing, chest pain or heartburn should contact their doctor.

A study published in the British medical journal, The Lancet, suggested recently that two antidepressants commonly given to patients with Alzheimer’s disease are not only ineffective but also cause side effects such as nausea and drowsiness.

The study focused on the drugs sertraline (Pfizer’s Zoloft) and mirtazapine (Remeron). These two classes of drugs are often prescribed to treat depression in Alzheimer’s patients, and following results from the study, were found to be “no more effective than the placebo,” said the study’s researchers. Given these findings, researchers are urging physicians to reconsider the way they treat depression in Alzheimer’s patients and to back away from the routine prescription antidepressants.

The study focused on a group of 326 Alzheimer’s patients from nine different clinical centers in Britain, all of whom had been diagnosed with depression lasting for at least four weeks. Patients were divided into three separate groups, 107 were given sertraline, 108 mirtazapine and 111 a placebo. At the end of a 39 week period, researchers found no significant differences among the groups. In fact, the patients who received one of the two antidepressants experienced more adverse reactions compared to those who took only a placebo.

No drugs currently exist that can alter or stop the course of Alzheimer’s, a disease which affects more than 25 million individuals worldwide.

The U.S. Food and Drug Administration recently urged drug manufacturer, AstraZeneca, to update the label of its blockbuster anti-psychotic medication, Seroquel, following the agency’s receipt of almost 17 individual reports from patients experiencing heart problems as a result of taking more than the recommended dose of the drug.

Following the FDA’s request, AstraZeneca released a statement that it would, in fact, add a warning to the drug’s label about the risk of potentially life-threatening heart rhythm problems when combined with certain other medications, as well as when taken in excess.

Seroquel is a popular anti-psychotic medication approved for use in the treatment of schizophrenia, bi-polar disorder and severe depression. The drug is a top-selling product for AstraZeneca, generating more than $5 billion in sales last year. Seroquel is often prescribed for off-label uses not previously approved by the FDA, such as autism, compulsive disorders and obsessive dementia. It has also been the subject of heated legal battles over the years, one of which resulted in a $520 million settlement pay-out by AstraZeneca, following government claims the company was engaging in illegal marketing activities.

The blockbuster anti-psychotic medication, Seroquel, is the focus of more legal drama for drug maker, AstraZeneca. The company is facing claims that it hid health risks associated with use of its top-selling drug when selling it to residents in Arkansas.

In March, AstraZeneca agreed to pay more than $68 million as a resolution to claims of deceptive marketing practices for Seroquel, and by September of 2012, the company will face trail in Arkansas over sales of the drug. The state is seeking a $5,000 penalty for each prescription written for the drug in Arkansas over an 11-year period, beginning in 1997. AstraZeneca officials remain confident that the company will be “fully vindicated” as the case against them moves forward.

AstraZeneca is the world’s second largest manufacturer of prescription drugs, and Seroquel is the company’s second-biggest selling product.

According to a recent article published in the American Journal of Medicine, three little words are costing patients big bucks. The phrase, “Dispense as Written,” is used by physicians in order to let the pharmacist filling your prescription know they must use a brand-name drug, as opposed to its generic counterpart.

Due to the fact many pharmaceutical drugs are no longer covered by patents, they can be manufactured by any company that makes prescription drugs, not just the company who originally invented the product. The manufacturing, marketing and sale of generic drugs have been a huge success in the United States and their use has saved the healthcare industry billions of dollars. At present, approximately 70 percent of all prescriptions written in this country are filled with a generic as opposed to brand.

According to the U.S. Food and Drug Administration, generic drugs contain the same active ingredients as their brand-name counterparts and also carry the same dosage, safety, strength, method of administration, quality, performance characteristics and intended use. Combine this fact with reports that use of generic products saved the American healthcare system more than $800 billion in the last decade, and it’s easy to understand why many states mandate that pharmacists dispense a generic drug whenever possible.

However, there is a way to get around these state mandates. The three words, “Dispense as Written,” accompanied by a check mark beside the box with the letters DAW, can essentially override the law. The article published in the American Journal of Medicine reported that out of a sample of 5.6 million prescriptions written for more than two million patients; approximately five percent were designated by physicians as DAW. While this may not seem like a large percentage, should the generics have been used, the savings would have been substantial.

Take the example of using the anti-cholesterol drug, Zocor. According to Drugs.com, a 90-pill bottle costs $459.98. A 90-pill bottle of simvastatin, the generic version of Zocor, costs only $83.97. Moreover, if simvastatin is purchased via a retailer’s special pricing program, the cost comes down to only $12.

Given the Supreme Court’s recent ruling, protecting the makers of generic drugs from liability associated with patients experiencing negative side effects as a result of using their products, it’s easy to see why this multi-layered issue continues to remain a cause for concern.

Source: The Washington Post