Increasing Side Effects : Is an FDA Policy Change in Order?

Sept. 13, 2007
ABC recently aired a Medical Minute video which detailed the increasing number of prescription drug side effects reported to the FDA by U.S. doctors over the past seven years. A reported 90,000 severe drug side effects were reported to the FDA in 2005 which seemed a dramatic increase from only 35,000 side effects reported in 1998. Of the 90,000 reported in 2005, over 15,000 deaths were involved, finding death most closely linked to pain medication and immune system drugs. Does the FDA need to re-examine their policy on the acceptable number of drug side effects? Is the existing system protecting patients? Is detailing the laundry list of "possible" side effects on medication inserts and/or other drug marketing such as commercials and advertisements enough? I, myself, always get caught up in the Lunesta commercial with the glowing butterfly guided by the rockabye musical accompaniment...however, I usually bounce back from Neverland when the narrator chimes in "Side effects may include unpleasant taste, drowsiness, headache, dizziness, and dependency." Should we as consumers be more careful about jumping on board for every prescription drug we think can cure our ailments? (1/4 of patients severely harmed by drug side effects were taking 5 prescription drugs or more). Should the FDA tighten their regulations and approval process? Or will we now be offered additional drug information such as "Do not mix X drug with Y and Z drug or you will most likely incur unpleasant taste, drowsiness, headache, dizziness, dependency and possible death" ? MV
ABC recently aired a Medical Minute video which detailed the increasing number of prescription drug side effects reported to the FDA by U.S. doctors over the past seven years. A reported 90,000 severe drug side effects were reported to the FDA in 2005 which seemed a dramatic increase from only 35,000 side effects reported in 1998. Of the 90,000 reported in 2005, over 15,000 deaths were involved, finding death most closely linked to pain medication and immune system drugs. Does the FDA need to re-examine their policy on the acceptable number of drug side effects? Is the existing system protecting patients? Is detailing the laundry list of "possible" side effects on medication inserts and/or other drug marketing such as commercials and advertisements enough? I, myself, always get caught up in the Lunesta commercial with the glowing butterfly guided by the rockabye musical accompaniment...however, I usually bounce back from Neverland when the narrator chimes in "Side effects may include unpleasant taste, drowsiness, headache, dizziness, and dependency." Should we as consumers be more careful about jumping on board for every prescription drug we think can cure our ailments? (1/4 of patients severely harmed by drug side effects were taking 5 prescription drugs or more). Should the FDA tighten their regulations and approval process? Or will we now be offered additional drug information such as "Do not mix X drug with Y and Z drug or you will most likely incur unpleasant taste, drowsiness, headache, dizziness, dependency and possible death" ? MV
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