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SCIENTISTS TRY TO CREATE NEW METHODS TO CATCH DANGEROUS DRUGS

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SCIENTISTS TRY TO CREATE NEW METHODS TO CATCH DANGEROUS DRUGS

Researchers from the University of Virginia and West Virginia University are trying to use technology to make drugs safer.  They are developing programs that would scour the internet’s patient chatrooms and websites for conversations and comments about adverse drug reactions.  Compiling this data would allow the medical and regulatory communities to address these issues much earlier than in the past.

This technology is already in use in other arenas, including with terrorism and studying consumer behavior. Continue reading SCIENTISTS TRY TO CREATE NEW METHODS TO CATCH DANGEROUS DRUGS

EXPIRED MEDS: UNSAFE OR ARBITRARY?

In the 1970s, the Food and Drug Administration began requiring that all prescription and over-the-counter medications carry an expiration date.  But with the cost of drugs so high, and drug shortages so commonplace, are there real reasons to be disposing of expired drugs?  There is now good reason to think that we might be throwing away perfectly good medicines.

A new study revealed that eight common drugs between 28 and 40 years old were just as safe and effective now as when they were manufactured.  In most, there was at least 90% of the active ingredient still present in the drug, which the FDA deems an acceptable amount of variation. Continue reading EXPIRED MEDS: UNSAFE OR ARBITRARY?

JAMA STATES THAT FDA TOO QUICK TO APPROVE PRADAXA

Is the FDA’s push to approve drugs more quickly costing too much in the way of patient safety?  According to an article published in the Journal of the American Medical Association by two drug-safety experts, the answer is yes.

They cite three drugs, including the controversial blood thinner Pradaxa, that were approved in an accelerated process and have resulted in serious patient safety issues. Continue reading JAMA STATES THAT FDA TOO QUICK TO APPROVE PRADAXA

LOOKING FOR NEW ALZHEIMER DRUG: PROMISE OR BUST?

Finding new treatments for serious diseases like Alzheimer’s is big business, but it has not proven easy for the pharmaceutical industry.  Both Pfizer and Johnson & Johnson both abandoned their Alzheimer’s drugs in late-stage trials, but Eli Lilly is hoping it can be the pioneer.  But is this new treatment just another spin on an ineffective drug hoping to tap into a $10 billion market? Continue reading LOOKING FOR NEW ALZHEIMER DRUG: PROMISE OR BUST?

THE QUIET RISE OF THE COMPOUNDING PHARMACY

With the recent fungal meningitis outbreak, the compounding pharmacy has come front and center in the line of attack.  People are wondering how these pharmacies have evaded federal regulation, and as a result we are likely to see changes in the way they are regulated.

But what has caused the rise of the compounding pharmacy?  How did this obscure business rise from a handful in 2000 to 3,000 in 2012? Continue reading THE QUIET RISE OF THE COMPOUNDING PHARMACY

PFIZER SETTLES INVESTOR LAWSUIT OVER CELEBREX

Drug giant Pfizer has agreed to pay $164 million to settle a shareholder class action lawsuit over Celebrex, a pain reliever that became the company’s 5th best-selling drug, pulling in $2.5 billion a year.

Pfizer was accused of misrepresenting the drug in clinical trials, making it appear safer than it actually was.

This is not the first litigation Pfizer has had to settle in relation to Celebrex.  In 2008, the company settled its personal injury suits for over $745 million.

A HEART DEVICE WITH KNOWN PROBLEMS NOT RECALLED UNTIL 2011

A defibrillator is a medical device that delivers a shock to the heart when a patient suffers a life-threatening arrhythmia.  To patients with heart problems, this device can be a lifesaver, and its proper functioning a matter of life and death.  But the Riata defibrillator, manufactured by St. Jude Medical, has been having problems with its leads since 2006.  Despite the fact that doctors were reporting abrasion issues to the company, a recall of the Riata defibrillator did not occur until 2011. Continue reading A HEART DEVICE WITH KNOWN PROBLEMS NOT RECALLED UNTIL 2011

ROCHE BEING INVESTIGATED FOR IGNORING SIDE EFFECT COMPLAINTS

The European Medicines Agency, similar to the FDA in the States, is launching infringement proceedings against drug giant Roche.  It is alleged that Roche failed to investigate over 80,000 reports from consumers of adverse effects of drugs sold in the United States.

The problem came to the attention of the EMA when a routine inspection revealed these 80,000 reports untouched in Roche’s computer system.  The 80,000 reports included over 15,000 deaths, but in spite of the severity, no evaluation of the cases had been done.  Instead the 19 drugs that are in question remain on the market without any investigation into their safety. Continue reading ROCHE BEING INVESTIGATED FOR IGNORING SIDE EFFECT COMPLAINTS

NEW TAINTED DRUGS MEANS MORE MENINGITIS

While it was initially thought that the recent fungal meningitis outbreak was a result of only one tainted steroid, there are reports this week that there are three new cases that are linked to different drugs made by the same compounding pharmacy.  The FDA is investigating, and has not provided any definitive answers yet.

The drugs that are under suspicion are another steroid and a drug used during heart surgery.   Doctors are now being told to contact all patients who received any injections made by the pharmacy.

ENERGY DRINKS BEING INVESTIGATED BY THE FDA

Energy drinks are now as popular and widely available as regular sodas, but they have seven times the amount of caffeine in them as a regular Coca-Cola.  The FDA is now investigating a young girl’s death, which is thought to be related to consumption of two Monster Energy Drinks.  In addition, there have been five other deaths linked to Monster Energy over the past three years.

A representative for the company denies that the deaths are linked to their products, but the FDA says that it has received numerous reports of issues with the product.  There have been five deaths that have been potentially linked to the drink, in addition to other health problems, such as abdominal pain, vomiting, tremors, and abnormal heart rate.  The FDA also states that these events are likely very underreported, meaning that many more problems are occurring but not being communicated to the FDA. Continue reading ENERGY DRINKS BEING INVESTIGATED BY THE FDA