Posted on April 06,2013 in Drugs

Modafinil is a medication that was created to treat shift work sleep disorder, narcolepsy and excessive sleepiness during the day as created by sleep apnea. This drug is only approved by the FDA to treat those symptoms. It works in a similar manner as a stimulant but because its effects on the human bodies are different, it is often referred to as a “wakefulness promoting agent”.

Yet, there has been an alarming increase in the usage of Modafinil for off-label disorders such as multiple sclerosis and depression. This is according to a new study initiated by Dr. David Claman and other colleagues from the University of California in San Francisco. From 2002 to 2009, this team took data from national Modafinil prescriptions and came to certain conclusions.

The results were staggering as the amount of prescriptions grew from nearly 60,000 to over 550,000. People receiving this medication for off-label conditions caused 89% of the increase. The side effects of the medication include headaches, drowsiness, stomach issues and dizziness. There have also been some cases of serious allergic reactions to the liver.

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 Posted on April 03,2013 in Drugs

People take over the counter pills for many ailments like headaches, colds and allergies. With summer coming up just around the corner, people also take dietary supplements to assist in weight loss to look better in their swimsuits. Also wedding season is beginning soon, when brides try desperately hard to look good in their dresses on the best nights of their lives. The bad news is that some defective drugs are on the shelves while they are being checked by the FDA.

A company in California named Green Planet, Inc. announced a voluntary recall of one of their products on March 11^th of this year after being sold to distributors and wholesalers from October 2012 up until the recall. The product was a diet pill marketed as the “Night Bullet”. It was found to contain small amounts of a prescription drug used to treat erectile dysfunction. This recall comes on the heels of the final test run on this supplement by the Food & Drug Association when the trace amounts were noticed.

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 Posted on March 30,2013 in Birth Defects

Recently, it was discovered in a study that Depakote use by pregnant women could cause lower IQ scores in their offspring. This is the latest of several suspected Depakote side effects that are ending in lawsuits.

Depakote is also known as valproate and is used extensively to help treat and manage epileptic seizures. It is also prescribed to treat manic depressive disorder, including bipolar disorder, which seems to be growing in occurrence each decade.

Depakote is also prescribed to treat problematic migraine headaches, a condition that has also increased in occurrence across North America in both genders.

One plaintiff of the birth defect lawsuit, however, claims that his mother ingested valproate for the first months of pregnancy and he was subsequently born with Spina Bifida, which he blames on the medication.

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 Posted on March 27,2013 in Defective Medical Devices

In 2012, the FDA received almost 900,000 adverse event and medical error reports from consumers—but only 5 per cent of those reports concerned children less than 18 years of age.

However, reporting adverse effects in pediatrics can help shed important light on these products, especially since most pediatric clinical trials only contain a small number of patients. In addition, a product may be studied in one age group and approved for widespread use but affect another age group in a different way.

Because of this, the FDA has issued steps you can take to report any adverse effects a child has experienced. In 2007, the FDA received reports of serious side effects in children who were exposed to prescription topical testosterone gel products. The contact was accidental, resulting when a child came in contact with the skin of an adult male who was using this product. However, from these complaints the FDA was able to work with testosterone gel manufacturers to create a safer product and identify places on the body where the gel could be safely applied to minimize child contact. They were also able to create stronger warning labels.

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 Posted on March 24,2013 in Defective Medical Devices

A recent New York Times report has revealed that Johnson & Johnson, makers of the hip implant device Articular Surface Replacement (ASR), became aware that its all-metal hip replacement device had an alarmingly high failure rate, not long after the company issued a recall for the device. The company's analysis showed that the device would fail within five years in nearly 40 percent of patients.

This analysis also found that over the next few years, the implant is likely to fail prematurely in thousands more patients. This is in addition to the thousands who have already had painful and costly medical procedures to replace the defective implants.

The Times reports that not only didn't Johnson & Johnson release this information; they were discovering it at a time when they were publicly dismissing the same kind of findings by a British implant registry.

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 Posted on March 21,2013 in Drugs

The Food and Drug Administration (FDA) recently announced a recall for one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, because these tablets may actually contain Meclizine HCl 25 mg tablets. Meclizine HCl is given for the treatment of nausea and vomiting. According to the FDA's press release, ingesting Meclizine HCl 25 mg as Ferrous Sulfate 325 mg “may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with imprinted kidney or liver function, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.”

The problem was discovered by a pharmacist, who complained to the manufacturer of the Ferrous Sulfate, Advance Pharmaceutical Inc. The company immediately issued a voluntary recall. The tablets were sold with the label Rugby Natural Iron Supplement Ferrous Sulfate in 100 count bottles. The lot of Rugby Ferrous Sulfate is 12G468 and expires on 7/14.

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 Posted on March 18,2013 in Defective Medical Devices

According to the FDA, a federal judge declared that a Californian company must stop manufacturing drugs and dietary supplements for domestic commerce—at least until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.

Titan Medical Enterprises, Inc. continuously failed to comply with Good Manufacturing Practice for drugs or Good Manufacturing Practice for dietary supplements. In addition, the company violated the Act by distributing unapproved new drugs.

Between 2001 and 2012, Titan Medical Enterprises, Inc. had been inspected by the FDA nine times and was found to be in violation of the Good Manufacturing Practice for drugs by failing to establish an adequate written testing program to assess the stability of finished products and failing to establish and follow adequate laboratory controls. The owner, James L. McDaniel, was given written notice in 2003 about the violations.

In 2007, the Good Manufacturing Practice for dietary supplements went into effect. Based on the company's size, the regulations were to be put into practice throughout the next three years. In 2010, 2011, and 2012, the FDA found Titan Medical Enterprises, Inc. to not be in compliance with various parts of the Act. These violations included failing to verify that a subset of finished dietary supplement batches met product specifications and failing to adequately confirm the identity of dietary supplement components.

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 Posted on March 16,2013 in Uncategorized

If you are anything like most people, when you run out of paper, need highlighters or just a pack of paper clips, the easiest thing to do is just to run to OfficeMax…or is it Office Depot? Oh, who knows – but it is the office store of guarantee just down the road. Soon, however, it won't make a difference; odds are the name might even be different.

OfficeMax and Office Depot are merging! Details about where the new merged company will be headquartered and even who will run it all is still up in the air, but Office Depot has declared it will issue 2.69 new shares of common stock for every outstanding common share OfficeMax has.

Both companies are a presence in the U.S. market with OfficeMax running 978 stores with 29,000 employees and Office Depot running 1,675 stores with 39,000 employees. With the two merging together, some stores will have to close because of proximity – an estimation of about 600 stores. This will help competitors like Staples.

Although it is still dependent on the Federal Trade Commission's approval, the merger is valued at about $976 million. Combined sales would be $18 billion and savings would reach about $400 to $600 million over three years. Board members would be chosen equally by both sides. Shareholders of Office Depot would be 54% owners while OfficeMax would be 46%.

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 Posted on March 15,2013 in Defective Medical Devices

At the end of February, Johnson & Johnson subsidiary Ethicon lost a landmark case in New Jersey, resulting in a $3.35 million payout to a South Dakota woman, according to Bloomberg News. Linda Gross, 47, sued Johnson & Johnson for failing to warn her of “the risks tied to its Gynecare Prolift vaginal mesh implant,” and for fraudulently misleading her. After constant pain and 18 operations sustained because of the implantation, Gross and her husband filed the lawsuit. The Atlantic City jury found that Johnson & Johnson “failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” not that the company defectively designed the mesh.

Gross was the first to file a lawsuit, one of 2,100 to be filed over the vaginal mesh implant. The company, according to Bloomberg, “will now weigh punitive damages that may total as much as $16.75 million.” Gross was awarded $1.1 million for pain and suffering, $180,000 for lost wages, $500,000 for future lost wages, $385,000 for past medical treatment, $1 million for future medical treatment, and $180,000 for her husband's loss of companionship and conjugal affections.

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 Posted on March 12,2013 in Drugs

A new Dutch study suggests that elderly people who use psychiatric drugs may have an increased risk for falling, according to the Chicago Tribune. Senior citizens who took medications including antidepressants and anti-psychotics were twice as likely to have fallen three or more times in the previous year. Although the study can't prove that the effects of the drugs directly caused more falls, psychiatric drugs often have side effects, including changes in thinking, attention and blood pressure levels, which may put seniors at higher risk for falling.

Elderly people are particularly prone to falls, which can cause hip fractures, severe injuries or even death. In 2009, over 20,000 American seniors died from fall injuries, according to the Centers for Disease Control and Prevention. Doctors recommend that psychiatric drugs should be avoided for elderly patients who also have other risk factors for falling.

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