Near Record Drug Approvals, Second Only to 2009.

It wasn't that long ago where I read a paper criticizing the rapid approval process in the United States as compared to other countries of the world who were more cautious in rushing to approve drugs that can potentially cause harm and death to its citizens - http://www.nature.com/nbt/journal/v29/n12/full/nbt1211-1066b.html?WT.ec_id=NB...


Americans will now participate in the Phase IV Post-Marketing Clinical Trials with these 35 new drugs.

"...says Janet Woodcock, director of the FDA Center for Drug Evaluation and Research. “As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy.”

Here's the FDA's high standards in deaths from previous drug approvals:

#1. Anti-emetics: Drugs to stop vomiting, common with chemotherapy in cancer patients. Examples are Compazine (15 deaths), Reglan (37), Marinol (4), Zofran (79), Anzemet (22), Kytril (36), and Tigan (3).

In the 10 year look back, these seven FDA-approved drugs killed a total of 197 people with normal use.

#2. Anti-spasmodics: Drugs to treat muscle spasms, widely used for the treatment of spastic movement disorders, especially in instances of spinal cord injury, spastic diplegia, cerebral palsy, multiple sclerosis, amyotrophic lateral sclerosis (Lou Gehrig's disease), peripheral neuropathy and trigeminal. All are very serious medical conditions. Examples of drugs to treat these conditions are Baclofen (72 deaths) and Zanaflex (46 deaths).

These two FDA-approved drugs killed a total of 118 people with normal use over 10 years.

#3. Anti-psychotics: Drugs used to treat psychosis. Haldol (450 deaths), Lithium (175), and Neurotin (968).

These three FDA-approved drugs killed a total of 1,595 people with normal use over 10 years.

#4. Others: Drugs for depression, attention deficit disorder, pain, and erectile dysfunction. Ritalin (121), Wellbutrin (1,132), Adderall (54), v!agra (2,254), and Vioxx (4,540).

These five FDA-approved drugs killed a total of 8,101 people with normal use over 10 years.

In total, 10,008 deaths due to company-tested drugs, with data reviewed by the FDA and approved for safe use in humans by M.D. prescription only. Tweet