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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Monthly Archives: November 2009

Will there be a crackdown on pharmaceutical data mining?

Posted in Off Label Marketing, Pharmaceutical Advertising

I sure hope so.  Because the ability of pharmaceuticals to find out how often doctors prescribe which medications allows those pharmaceuticals to engage in all sorts of shenanigans, like finding doctors open to ghostwriting and pushing for off-label prescription use. Washington Bureau – When your doctors writes you a prescription, that’s just between you, your… Continue Reading

Documents Available From Reglan (Metoclopramide) Lawsuits As of November of 2009

Posted in Reglan / Metoclopramide

Lawsuits over the drug Reglan (Metoclopramide) fascinate me because of the unique nature of the disorders the drug can cause.  Reglan can cause movement disorders like tardive dyskinesia.  Individuals suffering from these disorders lose control of their facial muscles and their limbs.  It’s incredibly strange to me that temporary use of this drug can cause… Continue Reading

FDA plans to speed reviews and visit China

Posted in FDA Regulation

I agree that visits to China should be at the top of the FDA priority list.  I’m not sure about increasing the speed of drug reviews, though, unless that speed increase comes from increased staff.  Asking existing staff to do more in less time is a recipe for another Vioxx disaster. NEW YORK (Reuters) –… Continue Reading

Second Fosamax Test Case Dismissed

Posted in Misc. Drugs

There are many lawsuits pending against Merck over its drug Fosamax.  There is evidence that the drug causes necrosis of the jaw.  I’ve seen pictures of people with this disease, and they look like normal people with the jaw of a rotting corpse.  It’s a terrible, horrible disease.  At this time, I don’t know of… Continue Reading

FDA employees will receive training at Duquesne University

Posted in FDA Regulation

These employees are charged with reviewing applications to market new drugs.  Obviously, the more training they get, the better.  (And if you didn’t know, it’s pronounce Dookane.) Duquesne University will have a hand in the training of federal employees charged with reviewing pharmaceuticals, as part of a consortium of schools that won a two-year $652,000… Continue Reading

New Warning for Users of Meridia

Posted in Misc. Drugs, Safety Alerts

This is fresh from the FDA.  If you’re using Meridia (Sibutramine) you may want to bring this up with your doctor: FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest,… Continue Reading

Class Action for Those Who Purchased Complete MoisturePlus

Posted in Lawsuits

Unfortunately, I had the opportunity to view some of the evidence against AMO in this case.  That evidence included graphic depictions of those who have lost their eyes or been forced to undergo eye surgery due to infections developed while using this solution.  (shudder)  Here’s some news about a class action lawsuit relating to the… Continue Reading

New Information About Drugs Used In Shoulder Pain Pumps

Posted in Misc. Drugs, Safety Alerts

One area I haven’t written much about yet is the association of chrondrolysis with drugs used in certain shoulder pain pumps.  Here’s some fresh information on that topic from the FDA: FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with… Continue Reading

Drugmakers Seek FDA Seal of Approval for Internet

Posted in FDA Regulation

This sounds like a fantastic idea to me. WASHINGTON, Nov 9 (Reuters) – A drug industry group on Monday urged the U.S. Food and Drug Administration to adopt a universal safety symbol for Internet content containing FDA-approved information about a medicine or medical device. The proposal from the Pharmaceutical Research and Manufacturers of America, which… Continue Reading

FDA Taking Interest In Link Between Gadolinium and Nephrogenic Systemic Fibrosis (NSF)

Posted in FDA Regulation, Misc. Drugs

I think I first learned about the link in early 2008.  Nice to see the FDA taking an interest. WASHINGTON, Nov 17 (Reuters) – Some contrast agents used with magnetic resonance imaging scans appear to carry a higher risk of a potentially fatal skin disease than others, U.S. drug reviewers said in documents released on… Continue Reading

Do you take Plavix and Prevacid? Then read this warning.

Posted in Safety Alerts

Fresh from the FDA a few minutes ago… [Posted 11/17/2009] FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid.  New data show that when clopidogrel and omeprazole are taken together, the effectiveness of… Continue Reading

Brand-name Pharmaceuticals Again Block Generics

Posted in Generic Drugs

Remember, one of the common arguments of the tort reform crowd is that trial lawyers keep drugs from coming to market.  If pharmaceuticals were really concerned about people having access to drugs, would they be doing this? WASHINGTON—The Federal Trade Commission expressed concern about the practices of brand-name drug makers after generic drug companies complained… Continue Reading

FDA Considering Outsourcing Core Functions

Posted in FDA Regulation

As if that wasn’t bad enough, they’re considering outsourcing them to a group with strong ties to the pharmaceutical industry.  Sounds like a bad idea to mw. WASHINGTON (Dow Jones)–The U.S. Food and Drug Administration is considering outsourcing decisions about the effectiveness of antibiotics, according to Rep. Rosa DeLauro (D., Conn.). "It is very troubling… Continue Reading

AstraZeneca Agrees to Pay Over Half a Billion Dollars For Offlabel Marketing of Seroquel

Posted in Off Label Marketing

Another good article from Duff Wilson at the New York times. The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel. One of the investigations related to “selected physicians who participated… Continue Reading

News about link between Byetta and acute renal failure

Posted in Byetta, Safety Alerts

Just got this in my email from the FDA: Byetta (exenatide) – Renal Failure Audience: Endocrine and nephrology healthcare professionals FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as… Continue Reading