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UPDATE ON MENINGITIS OUTBREAK

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FDA

UPDATE ON MENINGITIS OUTBREAK

There are new figures on the recent fungal meningitis outbreak that resulted from tainted steroid shots.  Now it is believed that 13,000 people received the shot, though not all the shots were given in the back.  The number of confirmed cases has now reached 105, with eight fatalities. These growing numbers are causing renewed attention…..

Posted in Pharmaceutical and Medical Device News,
Tagged meningitis, FDA, Meningitis Outbreak, New England Compounding Center,

DALLAS COMPOUNDING PHARMACY ACCUSED OF CAUSING DEATHS

With compounding pharmacies coming under scrutiny as a result of the recent meningitis outbreak, a Dallas compounding pharmacy whose mislabeled medications caused the deaths of three people in Washington State is coming to light.  The pharmacy, called ApotheCure, mixed an injectable painkiller that was 640% stronger than prescribed.

Posted in Pharmaceutical and Medical Device News,
Tagged FDA, Meningitis Outbreak, ApotheCure, Injectable Painkiller,

JOHNSON & JOHNSON TRIES TO ADDRESS CRITICAL DRUG SHORTAGE

Since 2010, ovarian cancer patients have been missing an effective and palatable chemotherapy drug called Doxil.  In 2010, FDA inspectors came upon contamination problems at the Ohio plant, and since then the drug has been in severe shortage.  About 7000 patients a year have used this drug, but by November of 2010, the only factory…..

Posted in Pharmaceutical and Medical Device News,
Tagged FDA, Doxil, J & J, Johnson & Johnson, Overian Cancer,

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…..

Posted in Pharmaceutical and Medical Device News,
Tagged FDA, Drug Safety and Research, Prozac,

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…..

Posted in Pharmaceutical and Medical Device News,
Tagged FDA, Drug Research, Drug Safety, Expired Medication,

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…..

Posted in Pharmaceutical and Medical Device News,
Tagged Blood Thinning Medication, Pradaxa, FDA, Caprelsa, Fingolimod, JAMA,

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? …..

Posted in Pharmaceutical and Medical Device News,
Tagged FDA, Compounding Pharmacy, Drug Shortage,

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…..

Posted in Pharmaceutical and Medical Device News,
Tagged FDA, Defibrilators, Heart Device, Riata,

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…..

Posted in Pharmaceutical and Medical Device News,
Tagged FDA, cancer drugs, European Medicines Agency, Flu vaccine, Roche,

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…..

Posted in Pharmaceutical and Medical Device News,
Tagged meningitis, FDA,