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Compounding Pharmacy In Texas Recalls Medication

A Texas-based compounding pharmacy is the latest facing a nationwide recall in what is quickly becoming a growing public health concern: tainted medications.

It is alleged that patients have become ill after taking products manufactured at Specialty Compounding, LLC, based in Cedar Park, Texas. Specialty Compounding is in the process of recalling all of the medicines manufactured in that facility dispensed since May 9, 2013 after at least 15 people developed bacterial infections traced back to the medicines.

Patients who received intravenous infusions of calcium gluconate, a drug to treat too much potassium or to correct calcium deficiencies, have reported issues after their treatment at Corpus Christi Medical Center Bay Area and Corpus Christi Medical Center Doctors Regional. It is suspected that the medication was not sterile, which caused bloodstream infections; Rhodococcus bacteria was detected, which typically causes symptoms including fever and pain.

The now-recalled batches of calcium gluconate were distributed directly to medical offices and hospitals throughout Texas, and also nationwide to patients, with the exception of North Carolina. Specialty Compounding has announced that is has contacted all customers to notify them of the recall; anyone who is in possession of the product should contact Specialty Compounding at (512) 219-0724 Monday through Friday, between 10:00 a.m. and 5:00 p.m. CDT, to find out how to return it.

A spokesperson for Specialty Compounding has announced that the company is voluntarily recalling all sterile products at this time out of concern for patient safety. The Federal Drug Administration inspected the facility in March 2013 and reported “questionable testing practices” and a lack of some procedures to establish drug sterility. Some drug processors were seen wearing improper clothing (i.e., not sterile), according to the findings, and it was noted that there was inadequate drug testing to ensure a lack of unwanted microorganisms.

This April, a new Senate bill was proposed which calls for much tighter regulations for the drug compounding industry. The FDA has called for an increase in its regulatory powers for compounding facilities; the regulatory powers typically fall under state regulations.

In 2012, a compounding facility in Framingham, Mass., The New England Compounding Center, was the center of an investigation after people in 20 states were affected; 750 were sickened, including 63 deaths. Contaminated drugs made at the facility caused an outbreak of fungal infections, including meningitis. More than 17,600 doses of methylprednisolone acetate steroid injections were affected. An investigation by FDA investigators discovered mold and fungal contamination in numerous vials of the drugs, and in areas where the drugs were made.

Blood Thinner Side Effects of Pradaxa Triggers Multiple Lawsuits

Following the formation of the pharmaceutical Pradaxa multidistrict litigation (MDL 2385) in late 2012, there have been more than 640 new federal claims filed. The majority of plaintiffs are alleging that the blood thinner has caused them internal bleeding and other potentially life-threatening side effects.

Dabigatran, better known as Pradaxa, marketed by Boehringer Ingelheim, is an anti-coagulant prescribed to millions of patients since its release in 2010. Now patients are coming forward with claims of life-threatening and other serious side effects.

An FDA MedWatch report states that Pradaxa caused at least 542 known deaths in 2011, the year after it was introduced to the public. Other reports include more than 2,350 cases of internal hemorrhaging, 644 strokes and almost 300 cases of acute renal failure. The most often cited side affects patients are claiming were caused by Pradaxa include gastrointestinal bleeding, brain hemorrhage, stroke, and heart attack.

The maker of Pradaxa, Boehringer Ingelheim, has been accused of concealment of risk, negligence, and strict product liability. The company has also been accused of failing to establish an internal bleeding protocol, failing to warn consumers of the high risks associated with taking Pradaxa, and failing to adequately research the medication’s safety and proper dosage.

Pradaxa has been a popular substitute for Warfarin, an anti-coagulant on the market for more than 50 years. Warfarin also increases the risk of internal bleeding, but the bleeding can be stopped with vitamin K. Pradaxa does not have a comparable antidote and there is no standard method to measure its anticoagulant effects.

Pradaxa lawsuits were consolidated in August 2012 to allow multiple litigants; four bellwether trials are scheduled for August 2014. Meanwhile, Pradaxa is still on the market and is considered a viable treatment option for those who need an anticoagulant. Anticoagulants are designed to reduce blood clotting or prevent blood clots. Anticoagulants are commonly prescribed to treat superficial venous thrombosis (SVT), deep vein clots, and deep venous thrombosis DVT. Anticoagulants are also commonly given when there is a risk of stroke.

As of April 2013, the label for Pradaxa contains a boxed warning which advises that discontinuing the medication may increase the risk of stroke.

If you or a loved one has been prescribed Pradaxa and have had any incidences of an adverse reaction, your experience should be immediately reported to the FDA.