Last year saw a record number of prescription and over-the-counter drug recalls, 1,472 different types in all. That number is four times the number of drugs recalled in 2008.
While it is difficult to attribute the increase in defective and dangerous drugs to a single reason, the overseas manufacture of medications, the increase in prescription drug use and faulty labeling all contribute to the dramatic rise in recalls. Based on the recalls of more than 130 million bottles of over-the-counter children’s medications like Tylenol and Motrin, the trend has continued in 2010.
A key issue confronting the U.S. Food and Drug Administration (FDA) in regulating both prescription and over-the-counter drugs is that as much as 80 percent of these products are now manufactured overseas. In countries like China and India, the manufacture of drugs does not conform to the strict guidelines mandated in the United States.
Most recently, certain doses of heparin – a blood-thinning prescription medication – were found to contain a harmful substance called chondroitin sulfate that was likely purposefully introduced when it was manufactured in China. In 2008, the FDA linked 19 deaths and hundreds of allergic reactions to the contaminant, according to the New York Times.
The heparin scare is just one reason why U.S. Senator Michael F. Bennet introduced new legislation that seeks to expand the FDA’s role in monitoring, testing and recalling prescription and over-the-counter medication. The Drug Safety and Accountability Act of 2010 (DSAA) is intended to improve the safety of drugs, whether they are manufactured at home or abroad.
Dangerous and Fatal Side Effects of Harmful Drugs
While nearly all prescription and over-the-counter drugs have potential side effects, some drugs have proven to be especially dangerous for those who are taking them. Examples of some of the more dangerous drugs include:
- Accutane (or its generic form Isotretinoin)
- Fentanyl (both pill and patch forms)
- Yaz / Yazmin
If a medication has been proven to cause harm, there could be questions about whether the drug manufacturer accurately and fully provided details about potential adverse reactions. If the manufacturer neglected to appropriately inform users and prescribing physicians of the harmful side effects, they can be held liable for the injuries and fatalities associated with the use of that drug.
One prescription drug, Accutane, is an example of a drug with exceptionally strong and potentially fatal side effects. While the drug has been on the market as an acne medication since 1982, serious problems began to emerge in the late 1990s. After a series of suicides by patients taking Accutane, researchers began linking depression to the use of the drug. The depression seemed particularly prevalent among teenagers. The recognition of this harmful, and often unnoticed, side effect led the FDA to issue a broad warning to all users of the acne medication.
As years passed, patients taking Accutane also reported a high rate of miscarriage and the presence of significant birth defects (including facial deformities and developmental delays).
Most recently, lawsuits have been filed by users of Accutane who have experienced serious gastrointestinal diseases and disorders, such as pancreatitis, Crohn’s disease, Ulcerative Colitis and Inflammatory Bowel Disease (IBD).
In response to the more than 1,000 lawsuits pending in state and federal courts throughout the country, Accutane’s manufacturer, Hoffman- La Roche, Inc., voluntarily recalled the prescription drug in 2009. The generic form, Isotretinoin, is still available. Despite the thousands of injuries alleged by Accutane users, the FDA never issued a recall in the nearly 30 years the drug was on the market.
Accutane is just one example of a popular and widely prescribed medication that has caused serious harm to unknowing consumers. Critics of the FDA argue that the agency is not adequately protecting the millions of Americans who take prescription drugs each day.
Who Is Responsible for Defective or Dangerous Drugs?
When the FDA approves a drug, the agency is effectively giving the drug the proverbial “green light” to enter the prescription or over-the-counter market. At that point, consumers of the drug generally assume that the drug has endured rigorous tests and is safe for its intended use. Unfortunately, that is not always the case.
The responsibility for disclosing potentially harmful effects of drugs lies with the drug’s manufacturer and/or distributor. The pharmaceutical company has a responsibility to accurately explain the side effects to ensure that consumers are fully informed when taking medications. If the company neglects its obligations or fails to disclose the severity of potential side effects, the company may be held liable for injuries caused by taking the medication.
Proposed Bill Seeks to Enhance FDA Oversight
The new bill, the Drug Safety and Accountability Act of 2010, was introduced to combat several challenges facing the regulation and safety of prescription and over-the-counter drugs. The main components of the bill provide the FDA with greater oversight power regardless of where the drug was manufactured.
If the bill is approved, the FDA would have the authority to issue mandatory recalls for drugs distributed in the U.S. and gain the power to assess civil penalties for violations of the Federal Food, Drug and Cosmetic Act (FFDCA). The agency would also be able to enter and inspect international drug manufacturing plants that produce drugs intended for consumers in the U.S.
The Pew Research Center’s Pew Prescription Project analyzed the bill and noted that under the requirements of the new bill, manufacturers would be required to ensure the “quality and safety of their drugs and active ingredients.” Manufacturers would also be tasked with tracking every entity involved in the creation of the drug, providing documentation for every involved in the production, processing and transportation of their medications.
If you or a loved one has been injured or killed as a result of a defective or dangerous drug, you may have legal recourse. Contact an attorney experienced in handling cases involving unsafe drugs to learn more about your rights and options.