New Trends: Off-label prescriptions

On May 18, 2009, In Product Safety, Uncategorized, By admin

With so many instructions and warnings on a bottle of prescription pills, one would think that the last person to disregard the intended use of a drug would be the doctor prescribing it. “Off-label” prescriptions are exactly that, and a number of legal cases are coming to trial because of the growing trend in pharmaceutical marketing of encouraging this practice.

Off-label presciptions exist in a gray area of medicine. Birth control is regularly prescribed for minimizing menstrual cramps and clearing up acne. Rogaine’s use for baldness was prescribed off-label for years before the FDA approved it. So that while the practice is not in keeping with FDA regulations, some advocates claim that the practice is not necessarily illegal either.

James Beck, a defense attorney and co-author of the Drug and Device Law blog, claims that most off-label use is beneficial and it is only the few disasters that get noticed. In fact, in 2008 the FDA rules for the promotion of off-label drug use became lax, but the Obama administration has yet to review these new regulations.

However the cases that have come to trial have not been about doctors finding creative ways to treat patients; they are about corporate marketing systems designed to create new outlets for sales.

For example, in March, Johnson & Johnson was ordered to pay the state of West Virginia $3.95 million for misleading doctors about the risks and benefits of Risperdal, an antipsychotic. The pharmaceutical giant is facing an even larger case in Texas. (http://industry.bnet.com/pharma/10001223/jj-fined-5000-per-sales-rep-visit-for-risperdal-mismarketing/).

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Will New Legislation Restore Right to Seek Justice in Defective Medical Device Case?

On March 20, 2009, In Uncategorized, By admin

The Supreme Court’s decision in Wyeth v. Levine that held that federal law does not preempt state-law claims with regard to drug warning labels. This decision returned the right to seek justice when an individual has been injured by a pharmaceutical product. The same right should be returned to those injured by a medical device that had been approved by the FDA .

An earlier decision, Reigal V. Medtronic, had held that manufacturers of class III medical devices that have been approved by the Food and Drug Administration’s (FDA) pre-market approval process were essentially immune from liability. The immunity could apply even in instances when a company knew a device was defective and dangerous, and had even been recalled.

“From peanut butter to unsterile syringes, we know the FDA alone cannot adequately police all drugs and medical devices on the market,” said Linda Lipsen, Senior Vice President of Public Affairs for the American Association for Justice. “That is why it is essential the civil justice system provide an added check and balance to strong federal regulations and oversight authority. “ If you or someone in your family has been injured by a fault medical device, seek the assistance of a qualified medical device attorney.

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Seroquel’s Known Risks of Diabetes Remain Sealed For Now

On March 18, 2009, In Uncategorized, By admin
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The Food and Drug Administration’s (FDA) advisory panel is meeting April 8 to determine if AstraZeneca can market Seroquel XR to patients for major depression and anxiety disorders, extending the market share to approximately 20 million more patients. The drug is currently approved for schizophrenia and bipolar disorder.

Unfortunately for consumers, this decision might be made without the full benefit of knowing what AstraZeneca knows about their drug and its potential side effects. Court documents, which the company refuses to make public, contain unpublished clinical trial information and internal conclusions by the company on the increased risk of weight gain and diabetes which were not previously shared with the FDA.

Sealed court records are hiding the dangers of prescription drugs and Seroquel is the latest example of how companies use secrecy agreements to hide product risks and mislead consumers into thinking they are safe,” said American Association for Justice  Senior Vice President of Public Affairs Linda Lipsen. “Companies that are unable to hide behind secrecy agreements would be motivated to fix or recall product dangers, preventing consumers from suffering unnecessary injury or death.”

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Supreme Court Upholds Consumer Rights for Safer Drugs

On March 4, 2009, In Product Safety, By admin

In a decision just released, the Supreme Court has upheld a 6.8 million dollar verdict for Diane Levine, (Levine v. Wyeth) and at the same time took a step in the right direction for making pharmaceutical drugs safer for all.

The plainiff, Diane Levine, was given a given “push injection” of the drug Pheneragen, manufactured by Wyeth.  She developed complications from an apparent mistake in the injection, and ultimately had to have her forearm amputated.

Although Levine won at the state level, Wyeth, appealed arguing that a 2006 regulation of the Food and Drug Administration should mean that such cases are barred at the state level.  Read more about preemption.

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Raptiva Serious Side Effects

On February 24, 2009, In Uncategorized, By admin

The FDA has received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in patients who were 47 to 73 years of age who were using Raptiva for the treatment of moderate to severe plaque psoriasis.
Two of the patients with confirmed PML and one patient with possible PML died. All four patients were treated with Raptiva continuously for more than three years. None of the patients were receiving other treatments that suppress the immune system while taking Raptiva.
PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. When PML occurs, it is usually in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is no known effective treatment for PML.
In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva.
Patients using Raptiva should:
Be aware that Raptiva increases the risk of developing PML. PML is a disease that is fatal or causes severe disability.
Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.
Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.
Contact their healthcare provider immediately if they experience these symptoms.
Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML
The FDA asks health care providers and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html.

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Diabetes syringes mislabeled and may cause death

On November 6, 2008, In Product Safety, By admin

Covidien Ltd is recalling nearly half a million single-use syringes that could pose a serious risk to diabetics.

During the packaging process, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin.

The ReliOn syringes were mislabeled  during the packaging process and could  lead to patients receiving an insulin overdose of as much as 2.5 times the intended dose which could in turn lead to low blood sugar levels and serious health consequences, including death.

The syringes were sold at Wal-Mart stores and Sam’s Clubs from August 1 until October 8, the FDA said.

The FDA said the manufacturer has received one adverse report related to a syringe from the lot numbered 813900.

Consumers and health care professionals who suspect they have the recalled product may contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

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Raptiva Receives New Warnings on Infections

On November 4, 2008, In Product Safety, By admin

RAPTIVA,a medicine given by injectionused to treat adult patients (18 years or older) with moderate to severe plaque psoriasis,  may cause life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

The FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight these risks.

In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.

Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

This release comes at a time when we await the Supreme Courts decision on Wyeth v. Levine that could determine whether federal regulation can block patients from suing drug makers in state courts. The question before the court is whether the Food and Drug Administration’s approval of drug labels should knock out state lawsuits that contend  the labels did not contain adequate warnings.

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Bush Administration’s Preemption Plot Confirmed by House Report

On November 1, 2008, In Product Safety, By admin

 

As Levine V. Wyeth gets ready to be argued in front of the Supreme Court on Monday, a report released from the House Oversight and Government Reform Committee: says that top scientists and career employees at the Food and Drug Administration had opposed the agency regulations that weaken consumers’ ability to sue drug makers.

The issue is language in a drug-labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends pre-emption, which is when federal regulations prevail when there is a conflict with state law. The concept of pre-emption is being used as a way to prevent a person from suing a drug company if they are injured by a drug, as long as the drug had recieved approval from the FDA.

The recently released report highlights internal FDA documents which show high-ranking career officials repeatedly warning about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval. 
 

The report cites Dr. John Jenkins, the highest official in FDA’s new drug review process, writing:
[M]uch of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”

 A copy of the report.

For Further Reading: Associated Press story on the issue:

LA Times story:

 

 

 

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More Deaths Reported from Byetta

On August 18, 2008, In Uncategorized, By admin

The FDA is working on a new warning label for Byetta a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co.

This comes as The Food and Drug Administration said Monday it has received six additional reports of patients developing a dangerous form of pancreatitis while taking Byetta. Two of the patients died and four were recovering.

The widely used diabetes drug causes acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain and death.

Last October the FDA issued an alert about 30 reports of Byetta patients developing pancreas problems. At that time Byetta’s makers agreed to add information about the reports to the drug’s label.

This is an example of how dangerous side effects of certain medications are not evident until after the FDA has approved the drug. If Wythe vs. Levine were to be successful, there will be no legal remedy for the damages incurred.

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Levequin and Cipro can Cause Injury to Tendons

On August 12, 2008, In Uncategorized, By admin

Now, because of mounting evidence that the drug levequin alsong with cirpro and others in it is class of flouroquinolone drugs, can cause injury to tendons and tendon ruptures, the FDA has issued its most urgent safety warning- THE BLACK BOX. 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.
In 2005 various groups including the consumer group Public Citizen began petitioning the FDA to put the black box warning on these drugs. They eventually sued the FDA prior to the FDA’s decision to take this action.

It is not really understood how these drugs cause the tendon ruptures but studies show that the drugs have a toxic effect on cellular components of connective tissue. The most commonly effected tendons are the Achilles tendon in the heel and the tendons connecting muscles to bones in the hand, shoulder and arm.

The FDA alert indicates that this risk is increased in patients over age 60 and in patients taking steroids. Physicians are advised to take patients off fluoroquinolone medications at the first sign of tendon pain or swelling.

The had filed a petition asking for these warnings two years ago and eventually sued the FDA prior to the FDA’s  The FDA would not cite a specific number, but admit they have received several hundred complaints

The warning now reads”Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin, during and after therapy. This risk is increased in patients over 65 years old, and is further increased with concomitant corticosteroid therapy. Discontinue in patients experiencing pain, inflammation, or tendon rupture.”

Unfortunately for some, the warning again comes too late.

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