Fairfield Pharmaceutical Products Law Blog

Connecticut residents should be warned that purchasing online prescriptions can be dangerous. Consumers may not be getting the drugs that they think they are when they choose to buy them from online retailers.

Experts say that most online pharmaceutical products are actually counterfeits of the real versions, and those counterfeit versions can lead to serious complications. They say that while the counterfeit versions of the drugs may look identical to the real drugs, they could be dangerous and defective drugs that contain harmful substances such as rat poison or metal in them. According to one study, only 3 percent of the online pharmaceutical companies are legitimate in the products they sell. Health care professionals advise that it's okay to purchase prescriptions online but that consumers should thoroughly research companies before doing so to prevent themselves from taking counterfeit versions that could harm them.

The Food and Drug Administration issued a warning on May 6 that women should not take drugs containing valproate sodium while pregnant because the drugs may lead to a lower IQ for their children. Drugs with valproate are typically produced by manufacturers to treat migraines, epilepsy and manic episodes associated with bipolar disorder. Affected drugs include Depacon, Depakote, Depakote CP, Depakote ER, Depakene and Stavzor.

The FDA based its warning on a new study called Neurodevelopmental Effects of Antiepileptic Drugs that showed that children whose mothers took valproate drugs prenatally may suffer lower IQ's. In the study, children whose mothers had taken the drugs in question had an IQ up to 11 points lower at age six than children whose mothers had taken other antiepileptic drugs. Another recent study showed that children whose mothers had taken valproate drugs had a five times greater chance to have autism compared to children who were not exposed to the drugs.

Balanced Solutions Compounding Pharmacy is recalling its sterile non-expired drug products because the drugs and supplies may have been exposed to bacteria. The drugs may have been used by Connecticut health care providers. In a recent inspection, FDA officials discovered gram-negative bacteria while sampling one of the company's chromium chloride injections. Gram-negative bacteria can cause disease, but typically, it does not cause infection in humans. FDA officials indicated that substandard practices and conditions led to the manufacturing of the dangerous and defective drugs.

The FDA is advising health care providers to check their supplies for Balanced Solutions products and to immediately return those products per the company's recall instructions. Patients who have recently been treated with the recalled products should contact their healthcare provider. More information about the recall can be found on the FDA's recall site.

St. Jude Medical, the manufacturer of Riata leads for defibrillators, is facing many lawsuits after more than 30 people died. The devices are intended to deliver a small jolt of electricity to the heart in order to restore a regular heartbeat. The deaths were allegedly caused by the defibrillator leads failing, delivering jolts of electricity too often or delivering too much electricity to patients. The problem is believed to have been caused by wires coming through the silicon coating. Medtronic faces liability along with St. Jude Medical as they distribute defibrillators.

The Riata leads were the subject of a defective medical device recall in December. St. Jude Medical stopped selling the product in 2010. A medical journal article published in March linked 22 deaths to the Riata leads. Doctors who implant such devices are leery of St. Jude Medical's newer Durata leads as the design is quite similar to the Riata leads.