Product News and Recalls

GSK settlement has lessons for consumers

According to a Consumer Reports blog entry, the recent historic $3 billion settlement against pharmaceutical giant GlaxoSmithKline carries some important lessons for consumers.

Prescribing a drug “off-label,” or for a purpose different from the use specified in its U.S. Food and Drug Administration approval, is legal. But promoting a drug for off-label use is not.

And apparently GSK did exactly that, through tactics that included misrepresenting research data to show benefits and hide safety problems. For example, the company promoted one of its drugs for use in children and adolescents even though it wasn’t approved for them. In fact, a number of studies had shown it was not effective in kids and was potentially dangerous, even suggesting that it increased the risk suicide and violence.

The charges in the recent settlement aren’t the only allegations involving GSK. Thousands of plaintiffs have filed suit over birth defects allegedly caused by antidepressants classified as selective serotonin reuptake inhibitors, or SSRIs. A number of studies have linked the use of SSRI antidepressants – which include Prozac and Zoloft – by pregnant women with potentially deadly heart and lung defects in newborns.

Consumer Reports gives the following advice for anyone who takes prescription drugs:

— Find out if a drug prescribed to you is approved to treat your condition and, if not, why your doctor thinks it makes sense for you.

— Don’t take free samples. As part of promoting the drugs for off-label use, GSK relied on free samples, given to doctors to be handed out to patients. Companies use free samples as marketing tools, especially for expensive, brand-name only medications. And when the samples run out, you’re stuck paying for the full price of the brand-name drug rather than a cheaper generic version.

— Be wary if you see drug company representatives in your doctor’s office, because they are typically there to attempt to influence your doctor to prescribe their drugs.

Patients should consult their doctors before making any changes in their medication. A consultation with an SSRI lawyer is also important if there are significant injuries from SSRIs.

See the story here: