The Food and Drug Administration has seized several plants belonging to the drug manufacturer Caraco Pharmaceutical Laboratories Ltd. for manufacturing violations.

The FDA cited multiple violations of manufacturing standards and seized approximately 33 different generic drugs at three different plants. The FDA will prevent Caraco from distributing anything until they have assurance that the company will comply with FDA standards in the future.

The drugs that were seized were generic forms of heart, pain, and psychiatric medicines. Caraco was accused of poor handling of drug ingredients and varying tablet-manufacturing processes.

People currently taking drugs made by Caraco should not be concerned and should continue to take their medications as prescribed. Any defective drugs should have been weeded out of the market already by recalls.

The seizure of these drugs could cause a shortage of choline magnesium trisalicylate oral tablets. If you are currently taking this medication and experience a supply shortage in your area, talk to your doctor about an alternative drug.

The Heart Rhythm Society has said that defibrillator lead wires need better surveillance to detect defects, and has called on hospitals to train doctors in the delicate procedure of removing such wires from patients.

The lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock, and in the worst case scenario, preventing a defibrillator from sending a necessary shock to the heart.

In 2007, Medtronic Inc.’s Sprint Fidelis lead was removed from the market following reports of 5 deaths due to lead fractures with another 13 deaths caused by “possible or likely contributing factor” of defective leads.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators, and around 150,000 people are still implanted with a Sprint Fidelis lead.

The Heart Rhythm Society used the Sprint Fidelis recall in its request for a surveillance system to track lead performance in order to spot defective devices earlier. The group also said hospitals need to train more doctors to remove faulty defibrillator leads.

During the Sprint Fidelis recall, four deaths occurred when doctors tried to remove defect leads from patients. The group said physicians should perform at least 40 extractions under expert supervision before operating on their own. Supervising physicians should have performed at least 75 extractions with a high rate of success, the group states. They also recommended that such training take place only medical centers that perform a large number of lead extractions each year should train physicians to perform the surgery.

Finally, the group called on the FDA to require that new defibrillator leads be tested in humans before they are approved. Currently, most leads are approved through the agency’s fast track process, which is reserved for devices that are considered modifications of existing products. The fast track process does not require human studies.

If you or someone you love has been injured by a defective medical device, it’s important to seek out expert advice of an experienced defective drug attorney for valuable insight.

The drug approved to treat lung and pancreatic cancers called Tarceva has been linked to serious side effects including potentially fatal digestive tract perforations, skin reactions and eye problems. The complications from this defective drug have prompted the Food & Drug Administration to announce new warnings for the drug’s label.

The drug Tarceva is one of a class of cancer drugs known as epidermal growth factor receptor (EGFR) trosine kinase inhibitors, which are treatments designed to block the EGFR protein. This protein is believed to play a role in cancer cell growth.

The risk for gastrointestinal perforations while undergoing Terceva therapy is greatest in patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease. According to the letter, some instances of perforation had been fatal.

In addition, some Tarceva patients had developed bullous, blistering and exfoliative skin conditions, even suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis. Some of the defective drug cases have resulted in deaths.