Houston Personal Injury Lawyer - FDA & Prescription Drugs

J & J Fighting Levaquin Bellwether Consolidation

Scott Kappes — Thu, 19 Nov 2009 15:04:14 GMT

Levaquin maker Johnson & Johnson is fighting attempts by plaintiffs to consolidate the first three bellwether levaquin lawsuits in to one trial.

The company is facing hundreds of levaquin lawsuits that have been filed in both state and federal courts. The lawsuits allege that the company’s popular antibiotic medication, Levaquin, is the cause of tendon ruptures, tendonitis, and other tendon problems that have been suffered by patients who have taken the medication.

Levaquin lawsuits filed in federal court have been consolidated into a multidistrict litigation (MDL) in the U.S. District court of Minnesota.

The first cases selected for trial are known as Bellwether cases. Bellwether trials play an important role in determining how a jury will react to the issues of that are present throughout the MDL and potentially laying the groundwork for a possible settlement.

Plaintiffs’ attorneys have proposed to consolidate the first three Bellwether cases into a single trial, claiming that the cases have similar injuries, claims, and situations and that would be more efficient for the court to handle them as a single trial.

Attorneys for the Johnson & Johnson, and it subsidiary Ortho-McNeil, disagree and argue that the potential differences in plaintiffs’ medical history and unique injuries suffered by each plaintiff may confuse the jury.

After years of pressure from the consumer advocates group Public Citizen, in July of 2008 the U.S. Food and Drug Administration (FDA) finally required the makers of Levaquin and other similar medications to update the warning labels for the class of antibiotics known as floroquinoles. The updated label now carries the FDA’s strongest available warning, the infamous black box warning, for an increased risk of tendon problems including tendon rupture in users of Levaquin and other flouroquinolone antibiotics.

Originally posted at InjuryBoard by Scott Kappes

Levaquin: A Prescription for Tendon Trouble

Scott Kappes — Wed, 30 Sep 2009 11:00:16 GMT

Thousands of people suffer tendon injuries each and every year. Many of these injuries are sustained as a result of strenuous physical activity or certain ailments that increase the likelihood of tendon injuries; however, many Americans are now suffering from tendonitis, tendon ruptures, and other tendon related injuries as a side effect of prescription antibiotic medications, like Levaquin.

Levaquin is a prescription antibiotic medication in a class of antibiotics known as flouroquinolones. In July of 2008 the U.S. Food and Drug Administration (FDA) added their highest available warning, the “black box” warning, to the label of Levaquin and other flouroquinolone medications due to a disproportionate number of tendon ruptures and tendonitis among flouroquinolone users.

The data the FDA looked at when deciding to issue the black box warning suggests that Achilles tendon ruptures occur 3 to 4 more times more frequently in patients treated with flouroquinolones than in the general public.

Flouroquinolones, like Levaquin, are commonly used to treat serious infections like pneumonia, chronic bronchitis, sinus infections, chronic prostate infection, acute kidney infection, and various types of skin infections. Levaquin has been linked to numerous serious side effects including tendonitis, tendon injury, tendon rupture, renal failure, toxic epidermal necrolysis, and many other side effects.

Adverse events associated with use of Levaquin and other flouroquinolone antibiotics should be reported to the FDA through the MedWatch reporting program, which and be reached by phone at 1-800-FDA-1088.

Experienced Injuryboard attorneys may be able to help those who have suffered debilitating injuries as a result of taking Levaquin. Victims of this dangerous medication may have the ability to recover compensation for medical expenses and other economic and compensatory damages that have been incurred due to their taking of Levaquin.

If you or a loved one have suffered a tendon rupture or tendonitis and have taken Levaquin, Injuryboard can help.

Originally posted at InjuryBoard by Scott Kappes

New Study Links Levaquin to Double Vision

Scott Kappes — Fri, 11 Sep 2009 17:48:00 GMT

According to a recent L.A. times blog post a new study has linked Levaquin, Cipro, and drugs in a group of antibiotics known as flouroquinolones, to the onset of double vision. When reviewing hundreds of reports of eye problems in people taking flouroquinolones researchers at the Casey Eye Institute at the Oregon Health and Science University discovered a disproportionate number of double vision occurrences.

Researched found 171 reports of double vision associated with the use of flouroquinolones, like Levaquin and Cipro. Flouroquinolones have previously been linked to tendon ruptures, tendinitis, liver damage, and other complications.

Numerous lawsuits have been filed throughout the nation on behalf of individuals who have suffered from tendinitis and extremely painful tendon ruptures associated with the use of flouroquinolones.

Luckily it appears that double vision symptoms associated with these medications are reversible. The study found that in 53 reported cases double vision symptoms subsided shortly after the antibiotics were discontinued.

It is unclear exactly why Levaquin and other similar medications appear to cause double vision; however, researchers speculate that the drugs may affect the tendons which control the eyes, leading to an inability to focus properly.

Originally posted at InjuryBoard by Scott Kappes

Arthritis Drugs Increase Cancer Risk in Children

Scott Kappes — Tue, 04 Aug 2009 18:07:52 GMT

The list of warnings associated with the class of medications commonly used to treat rheumatoid arthritis and other ailments continue to increase. Today the FDA announced that the labels for the popular arthritis drugs Remicade, Humira, Cimzia, Simponi, and Embrel will now carry a boxed warning to highlight an increased risk of cancer in children and adolescents that take these medications.

In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

The action the FDA took today is based on the completion of data that was first announced by the administration last June. Analysis of the data showed an increased risk of cancer in children and adolescents after about 30 months of treatment. Roughly half of the cancers were lymphomas and some reported cases of cancer were fatal.

More information is availible at the FDA website.

Originally posted at InjuryBoard by Scott Kappes

Warning for Reglan Users

Ashley Davis — Thu, 28 May 2009 18:30:13 GMT

Reglan is popular medication containing metoclopramide used to treat gastrointestinal disorders. Metoclopramide is a substance that helps to speed the stomach muscles, thereby shortening the time it takes for stomach contents to empty into the stomach. The FDA has ordered a "black box" warning, the FDA's strongest warning for all medications containing metoclopramide. Reports have recently shown a link between patents who use reglan and the development of a condition know as tardive dyskinesia. Unfortunately the symptoms are rarely reversible and there is no accepted treatment for them at this time.

Symptoms associated with the use of metoclopramide containing products:

Involuntary/ repetitive movements of the extremities
Lip smacking, pursing and puckering
Grimacing
Tongue protrusion
Rapid eye movements or blinking
Impaired movements of the fingers

Unfortunately the symptoms are rarely reversible and there is no accepted treatment for them at this time.

Brand names the FDA has listed as containing metoclopramide:

Reglan Tablets
Reglan Oral Disintegrating Tablets
Reglan Injection
Metoclopramide Oral Solution

If your loved ones have been effected by any of these products call Reich & Binstock today.

Originally posted at InjuryBoard by Ashley Davis

FDA Issues Recall for Hydroxycut Products

Scott Kappes — Fri, 01 May 2009 16:48:19 GMT

The U.S. Food and Drug Administration have issued a warning to consumers to immediately stop using Hydroxycut products over concerns of serious liver injuries associated with some Hydroxycut products. Iovate Health Sciences, the manufacturer of Hydroxycut, agreed recall their products from the market.

The FDA has received at least 23 reports of serious health problems associated with the use of Hydroxycut. Liver problems related to the use of Hydroxycut have ranged from jaundice and elevated liver enzymes to severe liver damage requiring a transplant. One death resulting from liver failure associated with the use of Hydroxycut has been reported to the FDA. Other Hydroxycut users have reported additional health problems including seizures, cardiovascular disorders, and rhabdomyolysis.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

Hydroxycut products were among the most popular dietary supplements available, controlling over 90 percent of the market in some areas.

Although the FDA has not received complaints of adverse reactions associated with all Hydroxycut products, Iovate has agreed to recall all of the products listed below.

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

For more information:

Hydroxycut Products

Dietary Supplements -- Overview

FDA 101: Dietary Supplements

NIH Office of Dietary Supplements

Originally posted at InjuryBoard by Scott Kappes

Caraco Digoxin Tablets Recalled for Potential Health Risks

Scott Kappes — Wed, 01 Apr 2009 18:35:46 GMT

Generic pharmaceutical maker Caraco Pharmacuetical Labratories has announced a nationwide recall of Caraco brand Digoxin tablets for possible overdose risks. The recall includes all Caraco brand Digoxin tablets (USP, .125mg & USP, .25mg) distributed before March 31,2009, that have not expired, and have an expiration date of before September of 2011.

The tablets are being recalled because the tablets may differ in size; therefore, may contain inadequate or excessive amounts of the active ingredient digoxin.

Digoxin is used to treat heart failure and abnormal heart rhythms. An overdose of digoxin can result in digoxin toxicity which can pose a significant health threat to individuals taking the medication.

Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consequently, as a precautionary measure, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers in possession of recalled batches of digoxin should immediately discontinue use of the tablets and contact their pharmacist for additional instructions.

For more information please see the FDA’s Digoxin Recall Press Release.

Originally posted at InjuryBoard by Scott Kappes

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

FDA Allows Drugmakers to Advise Doctors on Alternative Uses

Scott Kappes — Mon, 12 Jan 2009 17:55:38 GMT

Today regulators from the FDA issued guidelines for medical device and pharmaceutical companies to advise physicians about non-FDA-approved uses for their products. The original proposal, which was finalized today, allows devices manufacturers and drug makers to distribute medical journal articles describing unapproved uses.

By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for unapproved uses, a practice known as "off-label" use.

The new guidelines allow manufacturers to distribute medical literature that may suggest that a drug or device may be useful for unapproved uses.

The agency stated that they understand that this process could benefit public by providing health care professionals with scientific data and medical information that may not have been available in the past.

The FDA also added a statement to the provision encouraging companies to seek FDA approval for unapproved uses they believe their products may be useful in treating.

Originally posted at InjuryBoard by Scott Kappes