What happens when a drug that’s on the market starts showing
problems?
The first step is for the FDA to send letters to doctors making them
aware of the problem. Doctors can then educate the patients who are using
the drug.
The drug company can also change the warning labels on the drug packaging,
or produce special brochures that explain the potential side effects
to patients. They can do this voluntarily, or they may be required to
do it by the FDA.
If the occurrence of adverse side effects remains unacceptably high,
the drug may be placed under strict controls, requiring special waivers
to acquire a prescription. The acne medication Accutane is one example
of strict controls.
How is Accutane controlled?
Accutane causes birth defects.
It was released in 1982. The drug’s maker tried everything – red
warnings, illustrations of deformed babies, patient waiver forms, paying
for family planning counseling – still, some women get pregnant
while on Accutane, with resulting birth defects.
In 2005, the FDA created a special website where doctors and patients
must register to be eligible for Accutane prescriptions.
Female patients must prove they are not pregnant and receive a special
sticker on their prescription.
All prescriptions of Accutane are limited to a 30 day supply.
Vioxx has been in the news lately. When is a drug maker liable
for adverse reactions?
Liability occurs when the drug maker knew of the potential dangers but
didn’t adequately warn doctors or patients.
In the Vioxx cases, there is evidence that some of the potential for
increased heart attack risk was covered up by scientists working on the
trials.
Lawsuits involving Accutane, are not always based on birth defects,
since that is a known risk, but rather is based on the allegation that
the drug causes depression and suicidal feelings, and those risks are
not disclosed.
Vioxx was pulled off the shelf, but Accutane is still
available in some circumstances. What factors determine if a drug is
pulled, or simply controlled?
There are a number of conditions under which a drug is pulled from the
market. The drug is taken off the market if:
- The side effects are too numerous or too severe to be considered
as an acceptable risk, even under strict controls.
- If there are other drugs that provide the same benefit without
the risk.
- If warning labels and patient waivers fail to reduce the harm or
injury to patients.
There’s a risk involved when taking any drug, but patients
can’t protect themselves against unknown risks, that is why our
system allows lawsuits against the companies that profit off from selling
unsafe prescription drugs.
