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Foradil

Produced by drug maker Novartis, Foradil is an inhaled medication that improves breathing by dilating the body's airways. To use Foradil, patients place a capsule in an inhaler device (known as an aerolizer) and breathe in the medication.

However, despite its ability to prevent the severe breathing difficulties associated with asthma and chronic obstructive pulmonary disorder (COPD), Foradil has been reported to cause a number of serious side effects, the worst of which are life threatening.

Patients injured after using Foradil should:

• Find an alternative bronchodilator medication and stop using Foradil.
• Get immediate medical care to prevent further complications and death.
• Meet with a personal injury lawyer who specializes in Foradil lawsuits to find out if they have a case and are entitled to compensation for their injuries.

Foradil Side Effects

While many patients have used Foradil without experiencing health problems, when patients do develop serious Foradil side effects, they typically experience:

• arrhythmias
• breathing problems, including choking, wheezing or weak inhalation
• hypoglycemia, dangerously low blood sugar levels
• severe allergic reactions, including hives and facial swelling
• severe, worsened asthma attacks.

Ironically, although Foradil can prevent asthma attacks, it can also cause these episodes to be more severe and potentially fatal when they do occur.

Foradil users who begin to develop any of the above complications should seek emergency medical treatment to save their lives.

Risk Factors for Foradil Side Effects

Patients who are most likely to develop health problems after using Foradil include those with a history of:

• allergies
• diabetes
• heart problems
• hypertension
• seizure disorders
• thyroid problems

To minimize risk, patients should thoroughly discuss their medical history with their doctor before starting a Foradil regimen. Those who choose to start taking Foradil should:

• Be aware of all possible Foradil side effects and seek immediate medical attention should symptoms of these complications arise.
• Regularly visit their doctors, who can closely monitor their health and detect Foradil complications in their early stages.
• Use Foradil only as directed.

Foradil Lawsuits

After patients have received adequate treatment and stabilized their health, they should meet with an experienced Foradil attorney to:

• Find out if they have a provable legal claim against Novartis.
• Learn more about the process of and settlements in cases similar to their own.
• Determine whether initiating a personal injury lawsuit is right for their situation.

It's crucial to note that injured patients, as well as families of those who died after using Foradil, will likely be entitled to settlements that can compensate them for their:

• past, current and ongoing medical bills
• living expenses, should injured plaintiffs be unable to work for any period of time due to their Foradil injury
• pain and suffering

History of Foradil, Serevent and Advair’s Warnings

On July 13, 2005, the FDA's Pulmonary-Allergy Drugs Advisory Committee considered whether Novartis' Foradil and GlaxoSmithKline's Serevent and Advair should remain on the market. The committee of 14 asthma experts reviewed the data on the drugs and voted on whether currently available data supported continued marketing of the drugs. More than 21 million adults and eight million children in the United States have asthma.

The panel unanimously recommended the three asthma drugs remain on the market, but the committee urged more research to determine if the drugs might actually worsen asthma in certain patients. The panel also unanimously recommended the FDA require a black-box warning on Foradil's label.

In 2003, black-box warnings were added to Serevent's and Advair's labels - the FDA's strictest drug issued warnings - after a post-marketing study of Serevent and the final phase of Foradil's pre-approval showed a small, but significant, number of patients experienced severe exacerbations of their asthma. Foradil does not contain salmeterol, and did not have to carry the new warnings, but according to a panel member, Steven Gay, a lung specialist with the University of Michigan Health System, unless proven otherwise it must be assumed that the drug has the same effect as Serevent and Advair.
 
The drugs gained notoriety in November 2004 after FDA whistleblower David Graham named Serevent as one of five drugs that might be tied to safety concerns when speaking out about what he believed was the FDA's inability to protect the public from unsafe drugs. An FDA spokeswoman said Graham's comments regarding Serevent were not why the agency convened the advisory meeting on Foradil, Serevent and Advair and that it had been "in the works for a long time."
 
In a statement following the FDA advisory meeting, Novartis and Schering-Plough, which sells Foradil in the U.S., said that despite the differences in pharmacology Foradil and Serevent have, the companies would work closely with the agency should they decide to revise Foradil's label. The FDA is not required to accept its panel's recommendations, but the agency usually does.

In a Phase II trial comparing Foradil 12 mcg twice daily, Foradil 24 mcg twice-daily and placebo, there were four serious asthma exacerbations in the 24 mcg arm compared to zero in the 12 mcg and placebo arms. When Novartis conducted a 2,307 patient Phase IV examining the risk of acute exacerbation and worsening of asthma with 12 mcg and 24 mcg doses, two asthma exacerbations appeared with Foradil 24 mcg and five events appeared in with Foradil 12 mcg, compared to one even with placebo.

In 2004, Foradil worldwide sales totaled $320 million, according to a Novartis spokesman.

Have you or a loved one been injured after using Foradil? If so, contact us today to talk to an experienced Foradil lawyer who can help you evaluate your case, compile your lawsuit and win a highly deserved Foradil settlement.

 

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