FDA Approval Does Not Guarantee that Drugs are Safe or EffectiveJan 27, 2015
When the U.S. Food and Drug Administration (FDA) approves a drug, it does not necessarily mean that the drug is safe or effective for your condition. According to an investigative report by the Milwaukee Journal Sentinel, FDA approval does not guarantee safety or efficacy.
The investigation showed that in the last decade, diabetes drugs such as Januvia, Byetta and Victoza have been linked to 3,000 deaths and roughly 20,000 hospitalizations. The Journal Sentinel and its partner MedPage Today reported that none of the 30 new diabetes drugs have been shown to decrease the risk of heart attacks, strokes, blindness and other key complications.
According to Kearney Hub, the FDA approves diabetes drugs and other medications based on a surrogate measure, an interim measure for an eventual clinical outcome such as saving lives. For diabetes drugs, a surrogate measure may show that the drug lowers blood sugar and gets approved. Manufacturers do not actually have to prove that the drug prevents blindness or other complications.
Surrogate measures stem from changes made to FDA rules two decades ago, Kearney Hub reports. The agency faced pressure from politicians and drug companies, who wanted drugs on the market faster. The profits from diabetes drugs are exorbitant, with sales reaching $23 billion in 2013. According to Journal Sentinel, this figure is larger than revenue from the National Football League, Major League Baseball and the National Basketball Association combined.
Kearney Hub points out that while a number of drugs can help people, others are marketed under questionable premises. One example of this is prescribing diabetes medications for so-called “pre-diabetics”. “The trend to offer drugs to patients to delay a diagnosis of diabetes without making them healthier is a significant problem,” said Dr. Victor Montori, a diabetes expert at Mayo Clinic, to Kearney Hub. “Almost half of those included in the definition of patients with pre-diabetes won’t develop the disease in 10 years.”
There are a few things patients can do to potentially reduce the risk of an adverse event, Kearey Hub reports. Patients should take a look at a drug's “black-box warning”, which is placed when it is associated with serious or life-threatening side effects. Dr. Montori recommends that people should talk to their doctors about whether or not a particular drug is necessary and whether there are any other options. Kearney Hub also advises consumers to be aware of the side effects.
Patients can also check the website of http://dailymed.nlm.nih.gov/dailymed/index.cfmDailyMed, operated by the National Library of Medicine and the FDA, pharmacist Larry Sasich said to Kearney Hub. The site contains current product labels and medication guides for drugs that are associated with significant public health concerns.