Product News and Recalls

Antidepressant makers commit ethical breaches

An entry on the blog The mentions a civil complaint by the U.S. attorney’s office in Boston against drug maker Forest Laboratories, alleging the company defrauded the government out of millions of dollars by illegally marketing Celexa and Lexapro, two versions of the anti-depressant, “citalopram,” for unapproved uses in children and adolescents.

Doctors are allowed to prescribe drugs for uses not approved by the FDA, but it’s illegal for companies to promote drugs for those purposes.

Manufacturers of other antidepressants have faced similar charges recently. This month, a $3 billion settlement was announced against GlaxoSmithKline.

Prosecutors claim GlaxoSmithKline employed several tactics aimed at encouraging doctors to prescribe one of its drugs to children, including helping to publish a medical journal article that misreported data from a clinical trial. A warning was later added to the drug that it might increase the risk of suicidal thoughts in teenagers.

GlaxoSmithKline allegedly paid kickbacks to doctors who prescribed the company’s medications, including trips to luxurious spas and tickets to sporting events and concerts.

And plaintiffs in widespread lawsuits allege that GlaxoSmithKline and other manufacturers of antidepressants that are classified as selective serotonin reuptake inhibitors failed to adequately warn pregnant patients of studies linking the drugs to potentially dangerous heart and lung defects in newborns.

Other SSRI antidepressants include Prozac and Zoloft.

The charges against Forest Laboratories in Boston concerns two studies were done to help facilitate FDA approval of the company’s antidepressant for use in treating young people. One of the studies showed the drug was of no help to kids, and might even be harmful to them. The other, financed by the company, showed positive results.

As it promoted the positive study, the company buried the negative one for three years—even hiding it from its own medical advisers and sales reps — until the New York Times published an article about it in 2004.

Forest revealed both studies to the U.S. Food and Drug Administration in 2002. Although the FDA withheld pediatric approval of the drug as a result, it did not disclose the negative study’s findings to the public because “Forest had submitted them confidentially.”

The government lawsuit alleges that Forest provided things like baseball tickets, gift certificates to expensive restaurants, and paid vacations to doctors who agreed to prescribe its anti-depressant to kids, while federal programs were often tapped to foot the bill.

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

See the story here: