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

Monthly Archives: October 2009

Risperdal Sales Rep Was “Probably” Aware He Was Illegally Promoting Off-Label Use

Posted in Off Label Marketing

I’d love to get my hands on the transcripts for this case. Oct. 28 (Bloomberg) — A sales representative for Johnson & Johnson’s Janssen Pharmaceutica unit testified that he encouraged doctors to prescribe the antipsychotic drug Risperdal for unapproved uses. Matthew D. Thompson, testifying today in a trial over claims by a former co-worker, said… Continue Reading

New study shows risk of weight gain for users of antipsychotic drugs

Posted in Drug Studies

More evidence that certain drugs can cause diabetes… Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs. The study, to be published Wednesday in… Continue Reading

Another case of the FDA not being on the ball – how many people died because of this sort of lax enforcement?

Posted in FDA Regulation

Please give me one good reason why it should take years for the FDA to ban researchers who commit fraud. WASHINGTON — Delfina Hernandez helped to carry out one of the most audacious drug research frauds in American history, but because federal drug regulators sent a legal notice years late and to the wrong address,… Continue Reading

Tar Heel Students Protest Healthcare Reforms That May Raise The Cost of Generic Drugs

Posted in Generic Drugs

Sounds like a group of well-informed students: You’ve seen on television the shouting and angry protesting at town hall meetings across America. Most, if not all, are about the proposed healthcare reforms that are being considered in Congress. At the University of North Carolina, the issue is a hot topic, too. And the students concerned… Continue Reading

Rituxan and progressive multifocal leukoencephalopathy

Posted in Safety Alerts

From the FDA: Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have… Continue Reading

Pay-To-Delay Drug Deals Dying Due To Democrats

Posted in Politics

You tell me if this sounds competitive: Major pharmaceutical company develops new drug.  Minor pharmaceutical company wants to bring generic version on the market at a much lower price.  Major pharmaceutical company pays minor pharmaceutical company not to release the drug.  In the eyes of some pharmaceutical industries, and some Republicans, that is a competitive… Continue Reading

Warning About Iron Dextran Injections

Posted in Misc. Drugs, Safety Alerts

I don’t always post FDA alerts, but when one involves possible fatalities, I do. [Posted 10/16/2009] American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose… Continue Reading

Jury Rules For Plaintiff in Paxil Birth Defect Lawsuit

Posted in Paxil Birth Defects

Glaxo plans to appeal, of course,  but this win is significant for the other 600 or so plaintiffs: After deliberating for seven hours, a state court jury in Philadelphia found Tuesday that GlaxoSmithKline failed to properly warn doctors and pregnant women about risks associated with its blockbuster antidepressant Paxil. The jury awarded $2.5 million in… Continue Reading

Is this the beginning of the end of the off-label marketing ban?

Posted in FDA Regulation, Off Label Marketing

If Allergan is successful in challenging this rule, then FDA approval will become meaningless.  Pharmaceuticals will push drugs for any and every ailment under the sun, regardless of whether the drug has been shown to have safety or efficacy for that use.  Some would say that’s the world we already live in… Oct. 2 (Bloomberg)… Continue Reading

Complete List of Recalled Children’s Tylenol

Posted in Recalls

You’ve probably heard that Children’s Tylenol was recalled earlier this month.  Fresh from the FDA, here’s the complete list of all products that were recalled.  If you have any of them, DON’T USE THEM. 1) Children's Tylenol Plus, Multi-Symptom Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg,… Continue Reading

New site launched to help people who developed a movement disorder after using Reglan or Metoclopramide

Posted in Reglan / Metoclopramide

Metoclopramide is the generic version of Reglan.  New evidence has shown that individuals who use Reglan for 12 or more weeks are at a greater risk of developing a movement disorder such as tardive dyskinesia.  Here’s the excerpt of a lawsuit filed against a Metoclopramide manufacturer: 23. The package inserts for metoclopramide products, and the… Continue Reading