Pharmaceutical Legal Glossary
Glossary of Pharmaceutical Terms
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z #
Click on the first letter of the word from the list above to go to the appropriate section of the glossary.
- S -
Serentil: An antipsychotic drug for schizophrenics. Serentil
has been associated with other drugs that may cause cardiac arrhythmias
and sudden death.
Serzone: A prescription medication used to treat depression.
Cases of life-threatening liver failure have been reported in patients
treated with Serzone. Patients should be alert for signs and symptoms of
liver dysfunction and report them to their doctor immediately if they
occur.
Service of Process: Providing a formal notice to the defendant
that orders him to appear in court to answer plaintiff’s allegations.
Settlement: An arrangement by which parties in dispute come to an
agreement, usually involving some type of compromise exchange of valued
things. Over 90% of all lawsuits are settled out of court before a trial
ever takes place.
Sporanox: On May 9, 2001, The Food and Drug Administration issued
a Public Health Advisory to announce significant safety-related updates
to the labeling of Sporanox products and Lamisil tablets. Sporanox and
Lamisil are used to treat nail (onychomycosis), skin and other systemic
fungal infections. The FDA believes there is real risk of developing
congestive heart failure (CHF) associated with the use of Sporanox. Both
Sporanox and Lamisil have been associated with serious liver problems
resulting in liver failure, transplantation and even death. Results of
recent studies of Sporanox showed that the drug can weaken the force of
the heart muscle's contractions. This condition, sometimes called
"negative inotropic effect" was observed when Sporanox was injected
intravenously into anesthetized dogs and healthy human volunteers. In
these studies, the adverse effect on the heart muscle resolved once the
drug was stopped. Since becoming aware of the study findings, the FDA
analyzed US and international post-marketing adverse event reports
involving Sporanox that were received between its approval in September
1992 and April 2001. During this period, FDA received the following
event reports:
- 94 cases in which patients receiving Sporanox developed CHF
- In 58 of the 94 cases, FDA believes Sporanox contributed to or may have been the cause of CHF.
- In 26 of these 58 cases, Sporanox was being administered to treat fungal nail infections.
- Of these 58 patients, 28 were hospitalized. Death was reported in 13 cases.
In response to the study findings and the analysis of the
post-marketing adverse event reports, the FDA has added additional
information to the current warning in the Sporanox labeling. The warning
now states that Sporanox should not be administered for the treatment of
fungal nail infections in patients with evidence of cardiac dysfunction,
such as CHF, or a history of CHF. The revised Sporanox warning also
includes important information about heart-related adverse events caused
by drug interactions. If signs and symptoms of CHF occur during
treatment of fungal nail infections, the revised labeling recommends
that the use of Sporanox should be discontinued. The advisory also
alerts healthcare professionals to rare cases of serious liver problems
including liver failure, transplantation and death associated with the
use of Sporanox products and Lamisil tablets. While adverse liver
effects were previously included in the labeling for both products, the
FDA decided to include this information in the advisory because some
cases involved patients with no preexisting liver disease or any serious
underlying medical condition. As of March 2001, FDA has received and
reviewed 24 cases of liver failure possibly associated with Sporanox,
including 11 deaths. In almost half of the liver failure cases, subjects
received Sporanox for fungal nail infections or other dermatological
infections. Given the possible serious risks associated with Sporanox
products and Lamisil tablets, the new labeling for both products now
recommends that healthcare professionals should obtain nail specimens
for laboratory testing prior to prescribing the medications for fungal
nail infections, to confirm the diagnosis.
Stadol: A nasal spray form of analgesic (pain killer).
Bristol-Myers Squibb claims that Stadol has a much reduced risk of the
addictive qualities of other narcotics used to treat pain. Due to
manufacturer’s claim of an extremely low potential for abuse, the FDA
allowed physicians to prescribe Stadol without government control.
Contrary to the manufacturer’s claims, in the last few years it has been
revealed that the synthetic opiate in Stadol is extremely addictive and
has been blamed for several deaths. The FDA has logged reports a
significant amount of deaths and severe addictions associated with the
drug. An injectable version took the blame in some of those cases.
However the nasal spray has brought most of the complaints. The spray
has been linked to hundreds of cases of addiction and numerous deaths.
In February 1995 Bristol-Myers Squibb asked the FDA to recommend that
Stadol NS be considered a controlled substance. A year later, the
company expanded its request to contol Stadol NS by including the
injectable form of the drug used to sedate patients before surgery. For
Bristol-Myers, the request to control Stadol NS and restrict its sales
was unprecedented. By making a drug a controlled substance, makes it
more difficult for doctors to prescribe and may prompt some to choose
another painkiller. The question arises as to why Bristol-Myers Squibb
did not initially recommend Stadol NS to be labeled as a controlled
substance and why the company worked hard to argue the drugs
non-addictive benefits to FDA. These questions started to be asked when
the suicide of a medical doctor's son occurred. The father was Morris A.
Fisherl M.D., professor of neurology at Loyola University, Stritch
School of Medicine, Maywood, Illinois. After Fisher's son conunitted
suicide during treatment for an addiction for a supposedly "safe"
treatment for migraine headaches, Dr. Fisher and investigative reporter
Stephanie Glass gathered information on the drug. According to Fisher,
medical professionals and patients are not being informed about the
serious dangers associated with the drug Stadol which is delivered as a
nasal spray. Medical evidence, says Fisher, has always indicated that
Stadol should be scheduled for both effective control and as a caution
to physicians and patients as an addiction/dependence drug. In 1978, the
Federal Drug Administration Advisory Committee reviewed an indictable
form of Stadol. The committee recommended scheduling Stadol as
addictive, pointing out its abuse potential and withdrawal symptoms in
people who had received the drug during clinical trials. The committee's
recommendation was not followed.
Statute of Limitations: The time period within which a plaintiff
must file his action against the defendant. This time frame varies by
state. In North Carolina, the statute of limitations is three years.
Strict Liability: This holds manufacturers responsible for the
goods they produce, especially if they cause consumers injury.
Subpoena: A form issued by the court requiring someone to appear
in court and/or bring documents. (Also referred to as a “Summons.”)
Summary Judgment: In a civil action, any party may make this
procedural motion, after the Discovery phase, to dispose of the suit
before trial has begun. If a defendant files a summary judgment motion,
it essentially means that the defendant believes that the plaintiff's
case is too weak to go to trial and the suit should be thrown out.
Synthroid: On June 1st, 20001, the Wall Street Journal reported
that the Food and Drug Administration has told Abbott Laboratories the
maker of Synthroid, one of the nation's most frequently prescribed
drugs, that the medicine has a "history of problems" and can not be
recognized as safe and effective. Synthroid is taken by patients who
have hypothyroidism or other disorders of the thyroid. Tyroid
replacement therapy usually continues throughout the patient's lifetime.
The agency's statements raise the possibility that the 40-year-old drug,
which has never been officially approved for use by the FDA, will be
subject to regulatory action that could possibly remove the drug from
the market. Patients using Synthroid should be monitored with regular
blood tests to assess the effect the medication is having on thyroid
function and also to check for toxicity. Too much Synthroid can cause a
condition known as "thyroid storm". Patients might experience heart rate
irregularities. Clots can be dislodged, and, in some cases, may help
lead to stroke. At worst, a general hyperactive metabolic state can even
lead to death. The FDA has indicated that Synthroid needed to be
approved by August 14, 2001, but as of June 1, 2001, Abbott has
indicated that they have not even applied for approval. The FDA stated
they wouldn't rule out asking for the drug's removal and noted that
there are two other approved drugs in Synthroid's class that could
potentially fill any void left by Synthroid. Synthroid had sales of
$541.3 million in 2000 and, ranked by number of prescriptions written,
was the third most frequently prescribed drug in the country, according
to data compiled by IMS Health. Synthroid went on the market more than
four decades ago and never received formal approval from the FDA.
According to the Wall Street Journal, such approval was required but
neither the agency nor the drug's current owner is certain why it was
never received. In the mid-1990s, the FDA began compiling data on
adverse events associated with the use of Synthroid as well as with the
use of its competitors. In 1997, it noted that "almost every
manufacturer" of such drugs had reported recalls because of potency
problems.
