TOPAMAX, Already in Hot Water over Off-Label Promotion, Now Linked to Birth Defects

By John Saponaro –

Off-label promotion has become an ongoing issue over the past several years as pharmaceutical companies continue to violate government policies by advertising drugs for uses not approved by the FDA. Doctors remain able to prescribe drugs for off-label use based on their expertise; provided they are acting with the best interest of the patient in mind and there is sufficient evidence that suggests the benefits outweigh the risks.

Off-label prescribing occurs when a drug is used in a way for which it was not intended or as a therapy, cure, or treatment for one or more conditions for which it has not been approved. While this type of use can lead to a more expansive application of a successful drug, it can also cause a higher incidence of known side effects as well as unforeseen adverse reactions that can be quite serious − even deadly.

The off-label prescribing of drugs beyond the scope of their FDA approval has become a serious concern in recent years. Dosage levels, medical conditions, and treatment durations for which drugs were never intended or tested make the entire area of off-label use problematic at best. There is also the problem of off-label prescribing to age groups (infants, adolescents, and seniors) for which no, or insufficient, clinical data exists. At its worst, the practice can be downright deadly.

According to a 2011 article, Off-label indications (those not approved by the FDA) doubled from 1995 to 2008.

The incredibly strange thing about off-label use, however, is that doctors may prescribe drugs to treat conditions for which the Food and Drug Administration has even denied approval. Therefore, while a manufacturer cannot market a drug for an unapproved off-label use, a doctor may prescribe the drug for that use.

In a 2010 article, the consumer advocacy program, Public Citizen said Johnson & Johnson was responsible for paying $81 million in criminal and civil penalties for illegal off-label promotion of TOPAMAX.

Now, TOPAMAX and Johnson & Johnson find themselves in trouble again.

Originally developed by Ortho-McNeil – a subsidiary of Johnson & Johnson – TOPAMAX is an anti-epilepsy drug. In the past, TOPAMX has been illegally marketed for a variety of psychiatric conditions, including drug and alcohol dependency.

To make matters worse, the FDA recently found that TOPAMAX may lead to serious birth defects.

According to Worst Pills, Best Pills, women who used the drug during their first trimester were much more likely to give birth to a baby with cleft lip or cleft palate. With these conditions, parts of the lip or palate do not completely fuse together; leaving anything from a small notch in the lip to a large gap that can extend into the roof of the mouth or nose. The resulting defects can lead to problems with eating, talking, ear infections and appearance.

While these complications only arose in women taking TOPAMAX as an anti-epileptic, it should be noted that the same risks are likely to apply to women taking the drug for psychiatric disorders and other off-label uses.

A psychiatrist and whistleblower who was instrumental in blowing the lid on TOPAMAX in the first place, called it “outrageous that Ortho-McNeil would try to pay doctors to influence them to prescribe a drug for uses that clearly endangered patients’ health.”

The pharmaceutical companies will continue this behavior as long as the fines are marginal compared to the amount of money they stand to make from the illegal advertisement of the drug.

In addition to larger financial penalties, some groups are calling for stricter punishments and criminal charges for corporate officials involved in these cases.

In fact, Eric Blumberg, the chief litigator of the FDA has said that “…unless the government shows more resolve to criminally charge individuals – at all levels of the corporate hierarchy – … we can not expect to make progress in deterring… off-label promotion.”

The rise in illegal advertisement of drugs and subsequent penalties handed down from the federal government provides strong evidence that the multi-billion dollar pharmaceutical industry requires a high degree of governmental oversight, especially when those drugs have potentially serious side effects.

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