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Up to one third of FDA drugs have sev...
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Sandeep Singh Dhillon
Up to one third of FDA drugs have severe safety issues – MIMS Malaysia
Pharma Notables
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Despite President Trump’s support for faster drug approvals, nearly a third of the drugs deemed safe and effective by the Food and Administration (FDA) are found to have major safety issues years after their approval, according to researchers at the Yale School of Medicine.

The study, led by Dr Joseph Ross, a Yale professor of general medicine and public health policy, hopes that regulators will be able to identify drugs that may have hidden health risks. This could allow regulators to reinforce reviews, increase post-market monitoring, or boost data sharing for certain drugs.

“We seem to have decided as a society that we want drugs reviewed faster,” said Ross. Hence, it is critically important “that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively,” he added.

Many approved drugs required a “black box” warning

“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” said Ross. Previous studies by the Yale researchers gathered that the FDA approves drugs faster than its counterpart agency in Europe.

Among the 222 drugs approved by the agency between 2001 and 2010, 71 of them required a “black box” warning to indicate severe side effects or warranted a safety announcement about new risks to the public. In total, the FDA added 61 boxed warnings and issued 59 safety communications.

Furthermore, the agency withdrew three drugs, the anti-inflammatory drug valdecoxib, tegaserod maleate that treats irritable bowel syndrome and the psoriasis drug efalizumab. Valdecoxib and tegaserod maleate were withdrawn due to cardiovascular risks whereas efalizumab increased the risk of a rare and fatal brain infection.

“The majority of pivotal trials that form the basis for FDA approval enroll fewer than 1,000 patients with follow-up of six months or less, which may make it challenging to identify uncommon or long-term serious safety risks,” the study authors noted.

Additionally, the researchers found that the safety events arose within a median of 4.2 years, and the issues were more common among psychiatric drugs, biologic drugs and drugs approved near the regulatory deadline for approval.

“The high frequency of post-market safety events highlights the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.”

Financial implications of sped up approvals

When President Trump delivered his first speech to Congress, he addressed the FDA’s review process as “slow and burdensome”. He vowed to “slash the constraints” of the agency, though the FDA has been working more quickly than it has been throughout history.

However, a recent case on Alzheimer’s drugs shows the potential negative impact if the FDA adopts less-strict standards. The FDA’s decision on not to rush approval for Eli Lily’s experimental Alzheimer’s treatment, solanezumab, is said to have saved the American’s taxpayers USD100 billion over the past four years, as it was later found ineffective.

“The issue right now in the national conversation is this push to approve drugs faster and faster at all costs,” said researcher Dr Chana Sacks of Harvard Medical School and Brigham and Womens Hospital in Boston.

“The conversation usually focuses on the toxicity – the risks and benefits – of the drugs themselves. We wanted to think about the financial toxicity, which is very real, and what the financial implications might be of lowering standards,” she added.

In regards to the recent study, Angela Hoague, an FDA’s spokeswoman, said, “In general, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.” MIMS

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