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Dangerous Drugs: Side Effects Common After FDA Approval

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Recent research shows a dangerous problem with many newly approved drugs. Life-threatening side effects are common in the years following FDA approval. An article titled “Study: Side effects emerge after approval for many US drugs” details the new research. The article’s opening paragraph sums it up:

Almost one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected, sometimes life-threatening side effects or complications . . .

This new study followed all prescription drugs approved by the Food and Drug Administration (FDA) from 2001 through 2010. The drugs flagged because of serious post-approval problems included medications for common medical problems such as arthritis, infections, blood clots and depression. The study’s lead author (an associate professor at Yale University) said “the large percentage of problems was a surprise.” As for me — I’m not surprised.

At our law firm, we see many consumers suffering from dangerous drugs and defective medical devices. Consider medical devices like many surgical mesh products. Many of those products were approved by the FDA’s faulty 510(k) program without adequate testing. As a result, thousands upon thousands of surgical patients suffer pain and even long-term disability from certain products. We represented a number of women injured by defective transvaginal mesh implants. Some of these women suffered heartbreaking problems of pain and disability following their implants. Now, we are currently investigating two hernia mesh products because of significant post-implant problems. You can read more about these products (Ethicon Physiomesh and Atrium C-Qur Hernia Mesh) on the Hot Topics section of the Blackwell Law Firm website.

How often are innocent patients prescribed dangerous drugs with serious (and undisclosed) side effects? The list is long. Many of these dangerous drugs were approved by companies rushing them to market. The profits from the time a dangerous drug is first approved until the serious side effects are discovered by patients can be huge. Consider the diabetes drug Actos manufactured by Takeda. The company made blockbuster profits once the drug was approved. Then, patients began developing bladder cancer. When a case finally reached trial, experts testified the company had concealed safety information. Afterwards, Takeda settled. While Takeda paid a huge sum to settle the injury and death claims, its revenue from the drug was far greater. Revenue was many, many times greater than the eventual settlement.

What is one example of a fairly new drug with serious post-approval side effects coming to light? Invokana. You can read more about the diabetes drug Invokana on the Blackwell Law Firm website in the Hot Topics section. I have also written several blog posts about the drug as issues develop. In just a short time on the market, serious problems such as kidney failure, bone fractures, and leg / foot amputations began appearing. Did the manufacturer conceal problems? Did the manufacturer fail to test fully its drug? These issues will come to light. The problem is that many patients will suffer before the truth is fully revealed.

Does it profit drug companies to conceal safety issues and rush drugs to market? Yes, it does. Too often, drug companies put huge profits before patient safety. That is wrong and should be stopped.

Despite so many dangerous post-approval drug problems, drug companies and their lobbyists are pushing to “speed up” the regulatory process and get drugs to market sooner. However, research reveals:

Drugs brought to market through ‘accelerated’ approval were slightly more likely to have later safety issues than those approved through conventional channels . . .

Are current pre-approval clinical trials sufficient? In my opinion, no. A CBS news article discussing drug side effects notes:

Most FDA clinical trials enroll fewer than 1,000 patients with a follow-up period of six months or less, which may make it challenging to identify uncommon or longer-term safety risks.

Clinical trial are often inadequate, incomplete or biased. This is a real safety problem in our country. Many drugs receive approval when adequate testing would have raised serious concerns. I understand the need to get life-saving drugs to patients as quickly as possible. But, we need to balance that desire with a goal to keep bad drugs from harming the public.