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What to Do When Your Child’s Medication Is Under FDA Review

Finding out that your child’s medication under FDA review can be scary.

Parents tend to immediately think the worst, which can cause panic. I’m not going to tell you not to worry because all concerned parents do. However, I will tell you that knowing what to do in this situation can go a long way toward keeping your family calm and getting helpful, productive answers.

4 Steps to Responding to an FDA Review

First, remember that FDA reviews happen all the time for a wide variety of reasons. Some are serious, but a review alone isn’t necessarily cause for panic.

A review is different than a recall. According to the FDA website, “Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.”

While a review can sometimes result in a recall, this is not always the case. When you first find out that your child’s medication is under FDA review, there are four things you should do:

child's medication is under FDA review1. Immediately contact the prescribing doctor.
Ask the doctor if he has been given any additional medical information or advice from the pharmaceutical reps who distributed the medication. Find out whether he has done any additional research into the reasons for the FDA review and/or investigation.

2. Conduct your own research.
Next, use the Internet to do your own independent research. Google Alerts are a great way to get up-to-date news on the medications your child is taking, and WebMD has a great section on medication with current information. As you’re searching, ensure that you’re getting your information from accredited sites. To verify that a website is a credible source:

• Check the links to determine what sources, studies, and examples it’s using.
• Make sure the website’s credentials are clean, clear, and recognizable.
• Find out who runs the site. What type of group is it affiliated with? Is it run by an attorney or a doctor? Do these individuals or the organization have a reason to be biased or stand to gain from publishing this information?
• Do a quick background check to see what kind of qualifications the organization, company, or individuals who run the site have.

3. Go to the source.
Don’t rely on secondhand information. Go directly to the FDA website, and find out what the specific warning was. Then, consider whether the medication has affected your child in the same way as the incident that prompted the review. Going directly to the FDA is the best way to get the most accurate, impartial, and unemotional information about what is (or is not) going on. The FDA has a responsibility to inform the public of its findings and educate them about what steps should be taken.

4. Ask the prescribing doctor questions.
The doctor is the person who initially prescribed the medication. It’s up to the parent and the physician to determine whether the medicine is something they want to continue or if there’s a better alternative not under review. Once you’ve completed steps one through three, go back to the doctor and ask him questions that will help you make decisions about the medication, such as:

• Did the pharmaceutical company inform you of all the side effects that the drug may have?
• Are you taking other patients off the medication? Why or why not?
• Do you recommend that my child remain on this medication?
• Are there any alternative medications my child could take instead?

Don’t Blame the Doctor: It’s a Team Effort

Doctors aren’t perfect, so don’t go on the attack. Your child’s health is the responsibility of both you and the doctor. Doctors are not anticipating that the FDA will take a drug under review. The FDA has to wait until a complaint is filed or an unusual side effect is reported. Parents should be aware of the different types of medication their children are ingesting, the effects of those medications, and any potentially adverse reactions the medication could cause.

As a parent, you are the next best thing to your child’s own doctor because you’ll be the first to see any immediate side effects from prescribed medications. Doctors rely on your observations as part of their decision-making process, so it’s critical that you are observant and knowledgeable. Your child’s safety and well-being are a team effort.

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About Michael Acosta

Michael Acosta is a partner at Acosta & Williams LLC. As an attorney, he specializes in the areas of pharmaceutical litigation, personal injury, premises liability, auto and truck accidents, toxic torts, property and air contamination, and wrongful death. He is licensed to practice in the courts of Pennsylvania and New Jersey. Connect with Michael on Twitter and Google+.

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