Houston Personal Injury Lawyer - FDA & Prescription Drugs - Most Commented

Severe Injuries Linked to Levaquin

Scott Kappes — Mon, 28 Jul 2008 16:08:00 GMT

Levaquin is and antibiotic medication that was recently given a “black box” warning from the FDA. Levaquin is in a class of antibiotic medications known as fluoroquinolones that are used to treat certain types of infections. I have been searching the internet and the blogosphere and have heard hundreds of horror stories of people who have taken the Levaquin, or the similar drug Cipro, and will never be same because it.

It is astonishing to read the claims made by victims of these dangerous medications. The “black box” warning recently issued is long overdue if the stories posted on forums and around the blogospere are any indication as to the dangers that can be attributed to these drugs.

While this new warning cannot spare those who have already suffer such debilitating injuries as ruptured Achilles tendons and other severely painful and destructive adverse reactions as a result being prescribed Levaquin and Cipro, hopefully it will help reduce the number of victims that will have to suffer from these injuries in the future.

If you have suffered an injury related to the Levaquin or Cipro please post your comments here. Together we can spread the word about the dangers of these drugs and God willing spare others from the pain and agony that thousands have already been forced to endure.

Originally posted at InjuryBoard by Scott Kappes

Class I Recall Issued for Digitek Tablets

Scott Kappes — Mon, 28 Apr 2008 18:36:10 GMT

Today the Actavis Totowa LLC in conjunction with the FDA issued a Class I recall of all Digitek tablets. Digitek is used to treat abnormal heart rhythms and heart failure; however, the company has learned that some pills may be twice as thick and contain double the approved level of the active ingredient. Taking these double strength tablets could result in an elevated risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause low blood pressure, dizziness, cardiac instability, nausea, vomiting, and bradycardia (a heart rate below 60 bpm).The tablets are distributed by Mylan Pharmaceuticals Inc, under a “Bertek “label, and also by UDL Labratories Inc, under “UDL” a label.

Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions. Retailers are encouraged to remove all recalled products from their shelves and return to their place of purchase. Additiional information can be found at www.actavis.us.

Originally posted at InjuryBoard by Scott Kappes

“Black Box” Warning Issued for Levaquin and Cipro

Scott Kappes — Mon, 14 Jul 2008 17:11:43 GMT

Last week the FDA announced that fluoroquinolone antimicrobial drugs, like Levaquin and Cipro, would now carry the agency’s strictest warning. Antimicrobial drugs are used to treat or prevent certain types of serious bacterial infections, including pneumonia. These drugs have been linked to an increased risk of tendinitis and tendon rupture. The FDA notified manufacturers that the Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits outweigh the risks associated with the medications.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

The FDA also notified drug manufacturers that a Medication Guide should now be provided with this class of medication to ensure that patients understand the risks that they may be exposed to. The agency advised physicians that caution should be exercised when prescribing fluoroquinolones and said that each patient’s risk should be evaluated on a case-by-case basis.

Originally posted at InjuryBoard by Scott Kappes

FDA and Pfizer Ignored Doctor’s Concerns Over Chantix

Scott Kappes — Thu, 12 Jun 2008 18:05:46 GMT

Over the past several months concerns involving the prescription smoking cessation medication Chantix have been mounting. In the last quarter of 2007 the FDA received nearly 1000 reports of adverse events, more than any other drug, associated with Chantix. Today ABC News reported that when one of the nation’s top anti-smoking researchers, Dr. John Spangler, expressed his concerns over a year ago about possible adverse effects linked to prolonged use of the drug, both U.S. regulators and Pfizer brushed his thoughts aside. New studies now suggest that Spangler was ahead of the game with his questions about the safety of Chantix.

Earlier this year the FDA revised the label of Chantix to include warnings that the drug may have links to depression, nueropsychiatric events, and suicidal behavior, and last month a non profit organization released the results of a study that linked Chantix to metal confusion, lapses in alertness, dizziness, muscle spasms and loss of consciousness. This prompted the FAA to remove Chantix from the list of drugs that pilots and air traffic controllers are allowed to take. Days later the drug was removed from the list of acceptable medications for truck drivers.

Spangler says the safety study by researchers employed by Pfizer and published in a relatively obscure medical journal looked at far too few subjects — a total of only 251 taking the drug — to determine whether or not the drug is safe when used over that duration.

Yet, the conclusion of the study reads, "Varenicline 1 mg BID can be safely administered for up to 1 year" — a conclusion, Spangler says, that is not supported by the data.

Spangler also claims that the authors of the study also failed to mention that patients taking Chantix were two and half times more likely to experience serious adverse events.

While Pfizer maintains that the drug is safe to take for a one-year period, Chantix is designed to be taken for a maximum of 24 weeks.

We are just past the two-year mark for the approval ofChantix. It will be interesting to see what happens from this point out. Most experts say that we do know the true effects of a drug until seven years after approval, but with two label changes and thousands of adverse events reported we could be well on our way with Chantix.

Originally posted at InjuryBoard by Scott Kappes

Supreme Court Refuses To Hear Pre-Teen Murder Case

Scott Kappes — Wed, 16 Apr 2008 10:53:04 GMT

Yesterday the U.S. Supreme Court declined to hear the appeals case of a South Carolina adolescent that was sentenced to 30 years in prison without the possibility of parole, at the age of 12, for the brutal murder of his grandparents. Christopher Pittman’s attorneys argue that the sentence violates the constitutional ban on cruel and unjust punishment, as Pittman is the only person serving such an unforgiving sentence for a crime committed at such a young age.

At the time of the murders the pre-teen Pittman was taking the powerful antidepressant Zoloft, which some believe may have contributed to his actions. The sentence was upheld by the South Carolina Supreme Court, characterizing the sentence as warranted by the “brutal” nature of the crime. South Carolina Attorney General, Henry McMaster, urged the Supreme Court to not hear the case.

In his brief, McMaster pointed to what he said was a trend “towards increased punishment for violent juvenile offenders.'' He cited a number of cases of lengthy prison terms issued around the country to offenders who committed their crimes under the age of 15.

“There is simply no identifiable national consensus against imposition of the minimum adult sentence on a 12-year-old for a double murder,'' McMaster argued.

This may be true, but just because there is no “national consensus” that safeguards against these types of sentences, it doesn’t make them just. The 12-year-old boy that committed this crime suffered from depression and had spent time in a psychiatric facility in Florida prior to the offense. Pittman’s father removed him from the facility and sent him to live with his grandparents in South Carolina.

While in South Carolina, Pittman ran out of Paxil, and a doctor gave him samples of Zoloft. He soon began experiencing restlessness and became disruptive at school and church events, according to his lawyers.

On the night he killed his grandparents, Pittman had been reprimanded for his conduct at choir practice, and his grandfather had later paddled him. After the shooting, Pittman set fire to the house and fled in his grandparents' sport-utility vehicle.

In nearly every school shooting or seemingly random act of violence committed by a teens, some sort of antidepressant has been involved. From Columbine to Virginia Tech the actions of these mentally unstable young adults may have in some way been influenced by the antidepressant medications they were taking. I do believe that Christopher Pittman committed one of the most brutal and heinous crimes imaginable, but I also believe that sentencing a 12-year-old to spend the remainder of his childhood and the majority of his adult life behind bars even touches the root of the problem at large.

Originally posted at InjuryBoard by Scott Kappes

Hydrocodone in Unapproved Drugs

Scott Kappes — Tue, 02 Oct 2007 11:52:55 GMT

Friday the FDA posted a warning to healthcare professionals and consumers about the presence of hydrocodone in certain unapproved drugs. Hydrocodone is a powerful narcotic painkiller and cough suppressant and has been of the most commonly abused drugs out there. Abuse can lead to serious injury and even death in some cases. It has been reported to the FDA that several cough suppressants not approved by the FDA contain this dangerous narcotic.

The FDA is most concerned by the fact that some of these unapproved medicines are undoubtedly being used to suppress coughs in children, which could cause serious complications. There have not been any cough suppressants containing hydrocodone approved by the FDA for treating children under the age of six. The FDA has uncovered some hydrocodone cough suppressants with prescription instructions for children as young as two years old.

Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007, and must cease further shipment in interstate commerce on or before March 31, 2008. Further legal action could be taken against those failing to meet these deadlines.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

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

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

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

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