FDA Approval Is Insufficient Protection, Attorney Says Consumers Must Ask Critical Questions When Doctors Prescribe New Medications

Share Article

As recent news stories have shown, patients taking prescribed medications have experienced adverse and often dangerous reactions even though the drugs received FDA approval. Most consumers believe that FDA (U.S. Food & Drug Administration) approval means that a drug has been shown to be safe and effective. But too often the FDA doesn’t have all the relevant information leaving patients and doctors dangerously challenged in terms of a drug's safety, according to Los Angeles attorney Laura Gianni.

We have represented and continue to represent people whose lives are destroyed because unsafe FDA approved drugs were on the market

As recent news stories have shown, patients taking prescribed medications have experienced adverse and often dangerous reactions even though the drugs received FDA approval. Most consumers believe that FDA (U.S. Food & Drug Administration) approval means that a drug has been shown to be safe and effective. But too often the FDA doesn’t have all the relevant information to appropriately analyze the risk to consumers, according to Los Angeles attorney Laura Gianni.        

“Our clients and their doctors, like most people, believe that FDA approval means a drug is ‘safe’, but that is always a relative term when dealing with pharmaceutical products. Saying that a drug or medical device is FDA approved gives the public a false sense of security,” says Ms. Gianni, a partner at the law firm Gianni Petoyan, who has represented clients who used diet drugs Fen-Phen and Redux, Vioxx, Baycol and numerous other drugs or medical devices that were removed from the market because of their dangerous side effects.

“We have represented and continue to represent people whose lives are destroyed because unsafe FDA approved drugs were on the market,” she says.

All drugs must be FDA approved before they are marketed. According to Ms. Gianni, it is often the case that physicians, the public and the FDA don’t know the truth about a drug’s dangerous propensities until after a drug has been on the market a few years. “It is the manufacturer who knows, and often hides, the true information about the frequency or severity of dangerous side effects,” she says.    

Ms. Gianni has a list of questions she recommends her friends and family asks their physicians before starting a new drug. The five questions she recommends are:
1.    What is the diagnosis/condition you believe should be treated with medication, and is this drug approved to treat my condition?
2.     Are there lifestyle changes I could make, such as dietary changes or exercise, that would help my medical condition without prescribed medication?
3.    How long has this drug been on the market? If a drug has been on the market less than five years it may not have been on the market long enough for the FDA or physicians to evaluate the long-term effectiveness or side effects.
4.    If the doctor has prescribed the drug before, for how many years and for how many patients? If the doctor’s prescribing history is limited, a person may want to get additional information about the particular drug by reading the package insert or seeking as second opinion.
5.    Why did the doctor start prescribing this new drug? If the doctor says they learned about this drug at a recent seminar or from the drug representative, this is a red flag.

Ms. Gianni recommends that everyone take a proactive approach in consultation with their doctor to decide what prescription medications to take or not to take.

“I ask these questions of my doctors and my children’s doctors all the time,” she says.    “Doctors want what’s best for us, but with the challenges facing medical practices, doctors have less time to spend per patient and writing a prescription can be a quick solution. Like the FDA, doctors rely on drug companies to provide accurate information about the side effects. That’s why it’s imperative that patients be their own advocates.”

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Sydney Weisman
WHPR
323-730-0233
Email >

Kirsten Holguin
WHPR
805-796-0038
Email >
Visit website