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Billions of dollars are made each year by pharmaceutical companies from prescription drugs.  In 2011 the world's largest pharmaceutical manufacturer, Johnson & Johnson, made $65 billion in pharmaceutical sales. In the same year the U.S. set a new record with 4 billion prescriptions.

Defective Drug Attorney, Randall Spivey of Spivey Law Firm, Personal Injury Attorneys, P.A. said, "Prescription drugs can save lives and cure medical conditions. They may also do harm. It is important for patients and doctors to be aware of drug recalls."

Before a new drug comes to market in the United States, it goes through rigorous testing by the FDA (Food and Drug Administration) for safety and effectiveness. Once on the market both the FDA and the drug manufacturer continue to monitor the drug. Should serious problems arise, the FDA may issue a Black Box Warning, recommend a manufacturer's voluntary recall, or recall the drug.

The FDA uses the Black Box Warning on drug labels to notify the public of the most serious or life-threatening risks of taking the medication.  These warnings may be placed on new drugs or even drugs which have been on the market for years which have persistent, serious side effects.

Although the FDA continues to believe the benefits outweigh the risks, at the beginning of August, 2013 they added a Black Box Warning to acetaminophen, a popular pain and fever reducer, because it can cause rare but serious skin reactions.  Sharon Hertz, M.D., Deputy Director of the FDA's Division of Anesthesia, Analgesia and Addiction in a statement said, "Nonetheless, given the severity of the risk, it is important for patients and health care providers to be aware of it."

Under what circumstances can a drug be recalled?

Health Hazard

A drug may be recalled because it is a health hazard. Some hazards associated with drugs do not become evident until years of being used in the marketplace.  According to WebMD in 2010 the weight loss drug, Meridia (sibutramine) was recalled after it was found to increase a person's risk of heart attack and stroke.

Mislabeling or Poor Packaging

Medicines may be recalled because of wrong or misleading instructions on dosage and frequency, problems with any dosing tools, or confusing packaging.

Potential Contamination

Medicines may have been contaminated with harmful, or non-harmful, substances not listed on the labels and not intended to be medicine ingredients.

Not What it Says It Is

The medicine may say it is a pain reliever, but it is something else.

Poor Manufacture

The medicine's potency, purity and quality may have been compromised in the manufacturing stage.

How to find out about FDA drug recalls?

On the FDA website you may sign up for automatic alerts of recalls and market withdrawals.

What to do if your medication is recall?

If the medication is over-the-counter, stop taking it at once.  It can be returned to the place of purchase for a refund.  Doctors or pharmacists may recommend a safe substitute. Manufacturers also have hotlines for more information.

If the recall involves a prescription, WebMD recommends calling your physician or pharmacist as soon as possible to find out whether a replacement is needed.

For other tips to keep in mind should you have a drug which is recalled you may go to WebMD.

Defective Drug Attorney, Randall L. Spivey is a Board Certified Civil Trial Attorney – the highest recognition for competence bestowed by the Florida Bar and a distinction earned by just 1 percent of Florida attorneys. He has handled over 2,000 personal injury and wrongful death cases throughout Florida. For a free and confidential consultation to discuss your legal rights, contact the Spivey Law Firm, Personal Injury Attorneys, P.A., in Lee County at  239. 337.7483 or toll free at 1.888.477.4839, or by email to Randall@SpiveyLaw.com.  Visit SpiveyLaw.com  for more information. You can contact Spivey Law Firm, Personal Injury Attorneys, P.A. in Charlotte County at 941.764.7748 and in Collier County 239.793.7748.