Houston Personal Injury Lawyer - Dangerous Drugs

FDA Increases Reglan Warning for Tardive Dyskinesia

Scott Kappes — Fri, 20 Mar 2009 15:40:29 GMT

Recently the FDA announced that the heartburn drug, Reglan, and all other drug containing metoclopramide will now carry the administration’s strongest warning, the infamous “black box” warning. The label change was made to warn consumers, and health care professionals alike of an increased risk of developing tardive dyskinesia.

Tardive Dyskinesia is a movement disorder that involves repetitive involuntary movements or twitches.

The label of Reglan previous boxed warning; however, the seriousness of the risk of tardive dyskinesia will now be highlighted by the FDA’s strongest warning.

Patients taking Reglan should have been warned of the risk of tardive dyskinesia by their physician prior to being prescribed Reglan.

According to the FDA the risk of developing tardive dyskinesia increases the longer a patient takes Reglan. Higher doses of Reglan also increase a patient’s risk of developing tardive dyskinesia.

Metoclopramide drugs including Reglan are responsible for the majority of drug induced movement disorders. FDA studies suggest that about one out of every five patients who take Reglan or other metoclopramide drugs take them for a period of more than three month. These individuals are at the greatest risk of developing tardive dyskinesia.

If you or a loved one has been diagnosed with Tardive Dyskinesia and have taken Reglan or another metoclopramide medication we can help. Contact us today for a free case evaluation by an experienced Reglan lawyer.

Originally posted at InjuryBoard by Scott Kappes

Supreme Court Decision is a Victory for Consumers

Scott Kappes — Wed, 04 Mar 2009 16:01:42 GMT

This morning the United States Supreme Court ruled against the drug maker Wyeth in a decision that can be seen as a huge victory for the American public. The a surprising decision the Court ruled that pharmaceutical companies can be held liable for harm caused to individuals who take their medications, despite previous federal approval.

The justices reaffirmed a Vermont Supreme Court hearing that upheld a $7 million award to guitarist Diana Levine, who had to have part of her arm amputated after being improperly injected with the Wyeth’s anti-nausea medication Phenergan as part of a treatment for a migraine.

"The question we must decide is whether the FDA's approvals provide Wyeth with a complete defense to Levine's tort claims. We conclude that they do not," Justice John Paul Stevens concluded in the court's majority opinion.

Levine’s attorneys argued that Wyeth should have provided stronger warning for administering the drug in the method that cost Ms. Levine her arm, while Wyeth attorneys contended that the Food and Drug Administration’s approval of the medication should prevent or pre-empt any subsequent liability claims against the company.

Federal pre-emption has long been the goal of Big Pharma and in recent years has been supported by the republicans of the Bush administration.

Following last year’s Supreme Court decision that pre-empted state liability claims regarding medical devices that had been approved by the FDA, most experts believed that the Court would deliver a similar decision in the Levine case.

Justice Clarence Thomas concurred in the majority's judgment that federal law does not prevent the state lawsuit but used a different legal approach. Dissenting were Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito.

Today’s judgment can be seen as a monumental victory for consumer rights and hopefully will be the first or steps toward correcting the recent erosion the rights of citizens in favor of big business.

Originally posted at InjuryBoard by Scott Kappes

Former VA Secretary Turned Lobbyist, Questioned VA About Chantix

Scott Kappes — Wed, 09 Jul 2008 18:01:51 GMT

A new report from the Washington Times today claims that former Veterans' Affairs Secretary Anthony Principi called on his friends at the VA for answers concerning Pfizer’s smoking cessation medication, Chantix. Pricipi now works as a chief lobbyist for the pharmaceutical giant and reportedly contacted his former colleagues to inquire whether Chantix would remain on the VA’s approved list of medications after the drug had been linked to serious side effects.

The contact allegedly occurred shortly after the FAA removed Chantix from the list of medications that are acceptable for pilots and air traffic controllers to take, and Principi was apparently asked by Pfizer to use his connections to get the inside scoop on whether the VA was considering similar action. Pfizer maintains that Principi’s actions did constitute lobbying.

Last month the Washington Times broke a story that some 32,000 veterans who were taking Chantix as apart of a VA smoking cessation study who were not notified of FDA labeling changes made to Chantix in February. The labeling changes included warnings that Chantix had been linked to serious nueropsychiatric events, suicidal ideation, and completed suicide. The updated label also warned that these conditions could be exacerbated by preexisting mental conditions. Many of the veterans taking Chantix had recently returned from Iraq and were suffering from posttraumatic stress disorder (PTSD), making them prime candidates to experience adverse events related to Chantix. The VA did finally notify the patients taking Chantix, but only after one Iraq veteran was nearly gunned down by police while experiencing a psychotic episode allegedly induced by Chantix.

A review of the VA database used to track adverse events associated with Chantix the agency found 27 patients that had been hospitalized for psychiatric problems while taking Chantix. The 27 were made up of 11 attempted suicides, one attempted homicide, nine accounts of suicidal ideation, and six cases of patients suffering from hallucinations.

Today the House Committee on Veterans’ Affairs held the first hearing on the subject, entitled “Why Does the VA Continue to Give a Suicide-Inducing Drug to Veterans with PTSD?" It will be interesting to see just how much attention this gets by the national media. Chantix truly is a dangerous drug for some people, while others champion it as a lifesaver. But I think that everyone can agree, any drug that has been know to be linked to serious adverse effects and it is know that those effects can be exacerbated by mental illness, should not be given to veterans suffering from PTSD.

Originally posted at InjuryBoard by Scott Kappes