Pharmaceutical

Drug companies should not hide risk for birth defects

When pharmaceutical companies receive reports that suggest a medication may cause birth defects, they should immediately inform the public. However, too often companies are swayed by rising profits and the fear of bad press and may withhold or cover up this information to protect themselves. It is the public that stands to suffer.

This month, 13 Americans are suing Grunethal GmbH and companies now merged into GlaxoSmithKline and Sanofi, claiming the drug companies conspired to withhold the results of studies that showed their drug Thalidomide, used to treat morning sickness in pregnant women, caused birth defects, including missing and malformed limbs.

The plaintiffs were all born with birth defects between 1957 and 1962. The drug companies claim that the birth defects associated with Thalidomide were known in Europe, and that they could not have happened in the United States because the drug was only used in a limited clinical trial. The drug companies allege that the link between birth defects and Thalidomide was not known until 1961, however the lawsuits claim the companies were aware of the risks as early as 1955.

It’s taken 50 years for the victims of Thalidomide to seek justice, but lawsuits are already mounting against manufacturers of another class of drugs that studies show may cause serious birth defectsselective serotonin reuptake inhibitors, or SSRIs. These antidepressants are among the most prescribed medications in America, and many women are under the belief that these drugs are safe to use during pregnancy.

The truth is drug companies do receive complaints about their medication but are often slow to share the news. For example, women who used the SSRI Paxil during pregnancy and delivered babies with serious brain, heart and lung defects found out too late that their babies could have been spared injury if only they had been made aware of the possible risks associated with the drug.

It took several complaints for the Food and Drug Administration (FDA) to order stronger warnings on Paxil use during pregnancy. Many of those mothers are waiting for their day in court.

Source: Business Week