Side effects emerge after approval for many US drugs

Side effects emerge after approval for many US drugs

Of the 222 new drugs and biologics assessed, the study found 123 new postmarket safety events (three withdrawals, 61 boxed warnings and 59 FDA safety communications) during a median follow-up period of 11.7 years.

The study counted black-box warnings for dozens of drugs; these involved serious problems including deaths or life-threatening conditions linked with the drugs.

More positively, in only three cases (1.4 percent) was the issue so serious or widespread that the product had to be withdrawn.

Among the drugs with added warnings: Humira, used for arthritis and some other illnesses; Abilify, used for depression and other mental illness; and Pradaxa, a blood thinner.

"It is unprecedented that the FDA has approved a treatment without clinical trials conducted in the US, this saved years in the approval process", said Kim Hanna, President and CEO of The ALS Association Florida Chapter.

"We know that safety concerns, new ones, are going to be identified once a drug is used in a wider population".

"Aspirin has been around for hundreds of years". "We don't get a real-world representation", he said.

Although the percentage of safety events may sound high, Downing adds that it is "reassuring" that the system works well enough to catch these problems.

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"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", the agency said in an emailed statement.

How you view Ross's findings depends on whether you are a glass half-empty or glass half-full type of person. Once the FDA signs off, clinical trials - experiments that use human subjects to see whether a drug is effective and what side effects it may cause - get underway.

The urgent need for new medicines to treat ALS spurred FDA to take an unusually active role in securing Radicava's approval. President Donald Trump mentioned this priority in his first address to a joint session of Congress in January.

And many tend to be drugs that were rushed through the approval process.

The study showed that the treatments most likely to be flagged for safety concerns were those granted clearance under the agency's accelerated approval program, as well as medications for psychiatric disease, and those approved close to the deadline that had been set for the review.

AB Science told investors last February that its experimental drug masitinib improved symptoms of patients with amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, greater than a placebo, achieving the primary endpoint of a phase III study. Safety problems often crop up years later after therapies have been used by much larger numbers of patients.

Downing said the new study is a good argument for continuous monitoring of the safety of drugs "throughout their life cycle".

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