Category Archives: Prescription Drug Claims

FDA Raises Safety Concerns About Potential Fibromyalgia Drug

Written On August 19, 2010 By Bob Kraft

Wall Street Journal reports that the FDA revealed safety concerns about Jazz Pharmaceuticals Inc.’s potential fibromyalgia drug Rekinla (sodium oxybate), which faces a review on Friday from the FDA’s arthritis and drug-safety advisory committees. The drug is currently approved to treat narcolepsy under the brand name Vyrem, but would be dosed in a different way [...]

Posted in Consumer Information, Prescription Drug Claims

Drug Company Efforts to Outmaneuver the FDA Disturbingly Common

Written On August 13, 2010 By Bob Kraft

Time Magazine reports that the FDA panel’s recent decision to recommend keeping Avandia (rosiglitazone) on the market is “a move worth billions of dollars to GSK but that also may have put millions of patients at risk.” The move is also an example “of the drug industry’s outmaneuvering FDA regulators,” which is “disturbingly common, say [...]

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High Risk of Supplements Gets Exposed Again

Written On August 6, 2010 By Bob Kraft

It was disconcerting, to say the least, to read that Consumer Reports magazine, in its latest issue, labeled a dozen supplements as dangerous — especially because I have taken some of those supplements myself. USA Today agrees with my concern, and wrote about it in an editorial. Here are excerpts:
We Americans do love our dietary [...]

Posted in Consumer Information, Prescription Drug Claims, Product Liability or Medical Devices

Drug Studies Funded By Industry Are More Likely To Yield Good News

Written On August 4, 2010 By Bob Kraft

Did the headline of this post shock you? Yeah, me neither. But in a “dog bites man” story, the Los Angeles Times felt compelled to reveal the obvious — scientists tend to favor companies that pay them money rather than favor the general public. Who would have guessed?
Still, the article is interesting, and here are [...]

Posted in Prescription Drug Claims

Glaxo Ordered to End Avandia Drug Trial Enrollment

Written On July 23, 2010 By Bob Kraft

The Food and Drug Administration has ordered GlaxoSmithKline to stop enrolling people in a controversial clinical trial comparing diabetes drugs, and to notify more than 1,300 people already undergoing tests that they may be at greater risk for heart attacks because they have taken Avandia. The company has said it would comply with the FDA [...]

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Panelist Who Backed Avandia Gets Fees From Glaxo

Written On July 21, 2010 By Bob Kraft

The drug companies just keep doing it — buying positive reviews and reports. The latest evidence of that is detailed in a Wall Street Journal article about GlaxoSmithKline and it’s diabetes drug Avandia. Here are excerpts:
One of the panelists who voted in favor of the diabetes drug Avandia at a Food and Drug Administration advisory [...]

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FDA Panel Votes to Keep Avandia on Market With More Restrictions

Written On July 15, 2010 By Bob Kraft

ABC World News (7/14, story 5, 0:25, Sawyer) reported, “A surprise decision on Avandia [rosiglitazone]. Advisers to the Food and Drug Administration recommended keeping Avandia on the market,” although most “advisers did recommend stricter warning labels and the FDA will now decide which course to take.”
The New York Times (7/15, A1, Harris) reports on its front [...]

Posted in Prescription Drug Claims, Product Liability or Medical Devices

Two Studies Suggest Diabetes Drug Avandia Increases Risk of Heart Problems

Written On June 30, 2010 By Bob Kraft

ABC World News (6/28, story 7, 2:20, Sawyer) reported, “Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems.”
The Washington Post (6/29, Stein) reports that one study, “involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack.” [...]

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Pfizer to Withdraw Cancer Drug Mylotarg

Written On June 29, 2010 By Bob Kraft

The Food and Drug Administration said Monday Pfizer Inc. is withdrawing its cancer drug Mylotarg from the U.S. market after a clinical study showed the drug wasn’t effective and had more safety problems. The Wall Street Journal detailed this story well. Here are excerpts:
Mylotarg, marketed by Wyeth until Pfizer bought the company last year, was [...]

Posted in Prescription Drug Claims, Product Liability or Medical Devices

Blue Cross Blue Shield Sues Pfizer Over Drug Marketing and Illegal Kickbacks

Written On June 14, 2010 By Bob Kraft

Blue Cross Blue Shield of Texas, which is the largest health insurer in Texas, has filed suit in federal court in Texas against Pfizer Inc. for deceptive marketing of drugs and for illegal kickbacks to doctors.
The suit alleges that Pfizer promoted the sale of Bextra, an anti-inflammatory drug, for several uses that the government had declined [...]

Posted in Consumer Information, Prescription Drug Claims

Suicide Warnings Strengthened for Two Drugs

Written On June 9, 2010 By Bob Kraft

The drug maker Johnson & Johnson recently strengthened warnings about the risk of suicide with both Ultram and Ultracet painkillers. The impetus was the fact that deaths were reported in patients with histories of emotional disturbance or drug abuse. These drugs are especially dangerous when combined with alcohol use or with other prescription medication.
The new warnings [...]

Posted in Consumer Information, Prescription Drug Claims

Congress Investigating Johnson & Jonson’s “Phantom Recall”

Written On June 3, 2010 By Bob Kraft

Here’s a strange story about a mysterious “phantom” recall of Motrin drugs by the Johnson & Johnson company. Allegedly, the company hired a contractor to go to stores and buy all the available stock of defective tablets rather than announce a recall of the product. This came up at a Congressional hearing last week as Democratic [...]

Posted in Prescription Drug Claims, Product Liability or Medical Devices

Curbing Drug-Company Abuses: Are Fines Enough?

Written On June 2, 2010 By Bob Kraft

That’s the headline of a recent Time Magazine article. The question is whether relatively small fines (relative to drug company profits) are any real deterrent to continued false marketing practices. The article is a good read. Here are the opening paragraphs:
In late April, when the Justice Department announced its deal with AstraZeneca for the pharmaceutical [...]

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FDA May Disclose More Details on Drug and Food Safety

Written On May 21, 2010 By Bob Kraft

The Food and Drug Administration proposed this week to disclose more information about safety problems with the drugs and devices it rejects. This is the latest step in the agency’s efforts to combat criticism that it has become too secretive in its dealings with drug makers and food processors. There is good reason for some [...]

Posted in Government, Prescription Drug Claims

Translated Prescriptions Often Wrong – Half of Automated Spanish Versions Have Errors

Written On May 18, 2010 By Bob Kraft

This is a problem I never thought about before, but apparently it’s a quite serious one — erroneous translations of medication prescriptions for Spanish-speaking patients.
The problem, as reported in the Chicago Tribune, arises when pharmacies with no Spanish-speaking employees fill prescriptions for people who don’t speak English. The pharmacies must either go find someone who [...]

Posted in Consumer Information, Prescription Drug Claims

Johnson & Johnson Recalls Children’s Medicines

Written On May 4, 2010 By Bob Kraft

Johnson & Johnson has issued a massive recall of children’s liquid medications, primarily cold and sinus drugs.
The CBS Evening News reported, “The FDA…is advising consumers to avoid more than 40 liquid medications for children that are being recalled by the manufacturer because of quality problems.
The products include children’s and infants’ Tylenol, children’s and infants’ Motrin, [...]

Posted in Consumer Information, Prescription Drug Claims, Product Liability or Medical Devices

Yasmin and Yaz Birth Control Pills Cause Concern, But Are They Dangerous?

Written On April 22, 2010 By Bob Kraft

There has been much talk in both medical and legal circles recently about the oral contraceptives Yasmin and Yaz. The Los Angeles Times ran a good story about the contradictory test results on these products, and the confusion as to whether they might cause a greater risk of blood clots in young women. If you [...]

Posted in Consumer Information, Prescription Drug Claims

Pfizer Agrees to First Neurontin Lawsuit Settlement

Written On April 5, 2010 By Bob Kraft

Pfizer, the manufacturer of the epilepsy medication Neurontin has been involved in many claims by plaintiffs who blame the drug for creating suicidal tendencies. One such lawsuit, by a Massachusetts’ man’s survivors, has just been settled by Pfizer for a reported $400,000. The lawsuit was settled part-way through the trial. This is the first settlement [...]

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Avandia Diabetes Drug Supporters Had Financial Ties to Glaxo

Written On March 23, 2010 By Bob Kraft

A disturbing report by the Mayo Clinic alleges that about 90% of the scientists who published articles supporting GlaxoSmithKline’s diabetes drug Avandia had financial ties to the company, as reported by Bloomberg News. Here are excerpts from the article:
The Mayo researchers examined more than 200 articles that appeared after an analysis in the New England Journal [...]

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FDA Reviewing Information on Fosamax-Related Fractures

Written On March 10, 2010 By Bob Kraft

In a follow-up piece to Monday evening’s report on femur fractures related to Fosamax (alendronate), ABC World News (3/9, story 4, 2:20, Sawyer) reported that ABC’s Richard Besser, MD, interviewed FDA Deputy Commissioner Joshua Sharfstein, MD, asking him if now is the time for the agency “to send out a notice to physicians to be [...]

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