Jeremy Thurman on January 7, 2014
The Wall Street Journal is reporting that pharma giant Novartis is recalling 5.3 million bottles of blood pressure medication and other drugs that the company provided to physicians to be used as free samples for patients. The majority of the recalled lots were for Exforge and Exforge HCT, which treat hypertension. The other drugs involved in the recall are blood pressure drugs Diovan, Tekturna, Tekturna HCT; Lescol XL (cholesterol-lowering tablets) and Stalevo (Parkinson’s disease medication).
The recall is taking place because of trace amounts of an ink component on the bottle’s shrink-wrapping. Apparently, the ink migrated and affected some tablets in some lots of the sample-sized bottles, which each included seven tablets. However, the company is saying that there is no safety risk to patients – the recall was issued in order to ensure regulatory compliance and quality control.
Unfortunately, Novartis cannot track how many of the bottles have been distributed to patients; it only can monitor how many were provided to physicians’ offices. However, letters were sent to the physicians’ offices and Novartis coordinated a return process for the tainted drugs. The recall does not affect drugs sold to patients via pharmacies or distributed by wholesalers. If you received a sample of one of the drugs mentioned above from your physician in the past month, contact the physician’s office for additional information.
The FDA issued a warning in December to Star Scientific, Inc., maker of smoking cessation supplement CigRx and anti-inflammatory supplement Anatabloc. The FDA claims that these supplements contain anatabine, which is not allowed in dietary supplements. The chemical anatabine occurs naturally in cauliflower, eggplant, potatoes, tomatoes and tobacco, but it is an “investigational new drug” and dietary ingredient and has not yet been approved for use in dietary supplements.
Antabloc has been promoted to treat traumatic brain injuries and Alzheimer’s disease, but the FDA has warned against this. According to the Washington Post, the FDA has said that “… Anatabloc is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a ‘new drug’… new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA.” Although the chemical is found naturally in certain vegetables, it cannot be sold as a dietary supplement without prior approval.
There are more issues with prescription drugs than just recalls. Mistakes happen. Make sure that you’re in control of your own medication; check and double-check anything prescribed by the doctor or provided by the pharmacy. If you do run into complications from a prescription drug, whether from a doctor or pharmacy’s mistake or a defect or recall, we’re here to help. Oklahoma drug lawsuits are one of our areas of expertise. Call us – we can help.