Phenobarbital Recall in Canada Due to Oversized Tablets

Health Canada has issued a pms-Phenobarbital recall for 60 milligram tablets of the anxiety and seizure drug distributed by Pharmascience Inc., due to the possibility of that some tablets may be oversized. Receiving too much of the active medication could cause serious physical injury from overdose, such as coma or cardiac arrest.

Consumers in Canada have been urged to return any 60 mg pms-Phenobarbital to their pharmacist for replacement. However, Health Canada indicates that they should not stop taking the medication without first consulting with their doctor, as it could cause symptoms of withdrawal or an increase in seizures.

Phenobarbital is a barbiturate typically used to treat anxiety and sleep disorders that has been on the market since 1912. It is also widely used as an anticonvulsant to control seizures.

The Canadian recall of Phenobarbital was issued on June 26, 2009, after some oversized tablets were found on the market that contain more Phenobarbital than they were supposed to have. Pharmascience is the distributor of the drug in Canada and indicates that all lots of the 60mg format of the drug are being recalled.

Although no injuries or reactions have been reported to date, a Phenobarbital overdose could cause symptoms like decreased breathing and heart rate, lack of muscle coordination, impaired speech, extreme drowsiness and uncontrolled eye movements. Symptoms generally begin to appear within one to two hours, and could be life-threatening.

There is no indication at this time that the Phenobarbital recall will affect any products distributed in the United States, where it is manufactured by several companies. However, a number of U.S. generic drug makers have experienced manufacturing problems over the past two years involving oversized or undersized pills.

In April 2008, a Digitek recall was issued for all lots of the generic heart drug digoxin manufactured by Actavis Totowa at their New Jersey facility. At least 667 digoxin deaths among users of the drug were reportedly linked to the oversized tablets, according to FDA adverse event reports.

Earlier this year, Caraco Pharmaceutical Laboratories issued a generic digoxin recall for their version of the heart drug, due to manufacturing problems at their Michigan facilities which allowed some pills to contain too much or too little of the active drug. Last week, after the FDA identified continued problems with the drug maker adhering to the current Good Manufacturing Practice requirements, U.S. Marshalls shutdown Caraco’s production facilities and seized their inventory.

Late last year, all generic drugs manufactured by Ethex Corp. were recalled due to manufacturing problems which led to oversized tablets of morphine and other drugs being distributed. A lawsuit was filed last month in Illinois on behalf of three consumers who suffered a morphine overdose allegedly caused by the oversized tablets.