Articles Posted in Defective Drugs

Reglan, manufactured by Baxter Healthcare Corporation, has long been used in over 2 million children and adults for the treatment of gastrointestinal conditions such as diabetic gastroparesis disease and gastroesophageal reflux disease. The ill effects of Reglan use has not become fully apparent until recently. The FDA has announced that long term and high dose use of Reglan is linked to Tardive Dyskinesia, a highly disabling medical condition that creates repeated involuntary muscle movements of the face, tongue, eyes, arms and legs. This is particularly disheartening since the drug is only approved for short term use, but physicians have prescribed longer term use for many years. It is recommended that treatment not exceed three months.

Tardive Dyskinesia not only impedes day-to-day life, but is embarrassing because of involuntary body movements that may be rapid and jerky, slow and continuous. The lips may repeatedly grimace, the tongue may protrude irregularly, the eyes may move rapidly, the arms, legs and fingers may be impaired. There is no proven medical treatment for Tardive Dyskinesia, but the symptoms have decreased in a select number of people using Reglan once the medication was not used any longer.

Reglan has not been recalled by the FDA. Instead, there has been a black box warning placed on the drug label that describes the risk of Tardive Dyskinesia, even after the drug is stopped. The risk of Tardive Dyskinesia is greatest with long term or high dose use. This black box warning was placed following a high number of reports of Tardive Dyskinesia in Reglan users. Reglan is considered the most common cause for drug induced movement disorders.  Reglan, also known as Metoclopramide, is available in the form of tablets, syrups, and injections.

In November of 2009, Yaz and a similar product Ocella were recalled following reports of serious injury in users as young as thirteen years old. The problems associated with Yaz and Ocella involve the dosage of drospirenone which is known for creating health problems in users that live in European countries. In fact, the use of this ingredient in oral contraceptives was previously banned in several countries.

Since 2009, over 1,000 lawsuits have been filed against Bayer, the makers of Yaz. As more consumers become aware of the medical conditions that Yaz can cause, it is suspected that more lawsuits will arise in the case against Bayer.  The company’s Yaz product has been linked to fifty deaths in women that experienced blood clots while taking the oral contraceptive.

Women today have many choices available to prevent pregnancy. When a new option is introduced to the FDA, the product must meet specifications such as delivering a higher value to the user or providing an improved choice for the user when compared to other options. Other hormone medications such as Prempro have been linked to breast cancer.

Prempro is subject to another cause for alarm because of a recent recall. This drug recall affects two lots of the product, namely Lot C83323 (exp. 3-10) and Lot D82196 (exp. 12-10). Nearly, 50,000 cartons of Prempro are included in this particular drug recall.

Wyeth Pharmaceuticals, the manufacturer of Prempro, began the drug recall in January of 2010 by way of letter notification. However, people that have moved and have not changed their addresses may not be aware of the recall. The Prempro recall was initiated because the level of estrogen in the affected lots did not meet the specifications outlined in the company’s New Drug Application (NDA).

Prempro is used to treat menopausal symptoms. Wyeth also claimed that the drug improved cardiovascular activity.