Every month, the FDA posts a list of all drugs that have had “safety labeling changes to the contraindications, boxed warning, warnings, precautions, or adverse reactions sections.” In other words, these drugs are more dangerous, and dangerous in different ways, than their makers knew (or admitted) when they were declared fit for the American public. Now the pharmaceutical corporations have been forced to tell us about more dangers, problems, contraindications, and side effects regarding the products that millions of people are already using.
During 2003 and the first five months of 2004, an average of 40 drugs received revised labels each month, for an average of almost two every business day. May 2004 produced the highest number, a bumper crop of 65 new warnings, while March of that year came in second, with 59.
Even the massively marketed drugs that have become household names get hit. Clarinex, Effexor, Flonase, Flovent, Nasacort, Ritalin, Xanax, Zithromax, and Zyprexa are among those with new warnings during the time period.
Suprax (cefixime) — used to treat bacterial infections — now is admitted to cause angioedema (swelling of the heart), facial edema, hepatitis, jaundice, acute renal failure, seizures, and toxic epidermal necrolysis (death of the flesh). The new label tells us: “Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime.”
Vioxx, which is supposed to treat pain, now warns that it can cause: “Migraine with or without aura.” The heavily advertised allergy medication Zyrtec has been admitted to rarely cause blocking of the liver's bile ducts, swelling of the kidneys, destruction of red blood cells, hepatitis, involuntary facial movements, severely low blood pressure, stillbirth, and “aggressive reaction and convulsions.”
The “healing purple pill” Nexium had bad news after it was released, with some patients developing fatal cases of skin necrosis, not to mention nonfatal cases of pancreatitis and Stevens-Johnson syndrome. Invanz added hallucinations to its label when “post-marketing experience” showed that some patients started tripping after being injected with the antibacterial drug. Similarly, after the high blood pressure medication Atacand was already in use, it was reported to be deforming and killing fetuses. Merck had to add a new box warning to AquaMEPHYTON — its Vitamin K1 solution — when it began killing people, especially when given intravenously.
In one of the longest lags between a drug's introduction and a new warning, Demerol, a widely used pain reliever, got a new warning in February 2003: It passes straight into mother's milk, so suckling babies are ingesting this powerful, addictive narcotic if their mommies take it. Demerol was introduced in the 1930s. It took 70 years to discover that Demmies pass unaltered into breast milk?
Perhaps most significant, in spring 2004, after years of mounting evidence, six major antidepressants (Paxil, Wellbutrin, Effexor, Serzone, Celexa, Lexapro) finally received label changes warning doctors and shrinks to monitor patients for increased suicidality when starting, increasing, or decreasing any of the drugs.
One of the scariest label changes happened to Pletal (cilostazol) Tablets, which “are used to treat intermittent claudication, a condition in which a person experiences pain or discomfort when walking that stops with rest.” The “adverse reactions” portion of the label was updated in February 2004 to include the following litany of horrors that have shown up now that the public is taking the drug:
Postmarketing Experience
The following adverse events have been reported worldwide since the launch of Pletal in the US: pain, chest pain, hot flushes, cerebral hemorrhage, angina pectoris, hypotension, hepatic dysfunction/abnormal liver function tests, jaundice, vomiting, thrombocytopenia, leukopenia, bleeding tendency, paresthesia, hyperglycemia, pulmonary hemorrhage, interstitial pneumonia, pruritus, skin eruptions including Stevens-Johnson syndrome, rash, increase BUN, and hematuria.
The following adverse events occurred outside the US prior to marketing of Pletal in the US: pulmonary hemorrhage and Stevens-Johnson syndrome.
Did you catch that last sentence? Massive bleeding of the heart and an excruciating, disfiguring skin reaction that sometimes kills you showed up before the drug was offered in the US. But it was sold to Americans anyway. Thanks for the warning. 