[Consumer Reports] has recently identified 12 common prescription drugs that may have serious side effects, including heart attacks, certain cancers and even death. It says that "tens of millions of people may have been exposed to adverse side effects" from these drugs, which account for more than 266 million prescriptions in the U.S. and almost $25 billion in sales in the 12 months ending September, 2005!
Furthermore, in its investigation Consumer Reports has criticized the FDA for rushing to approve drugs, regardless of hidden risks and safety first.
The U.S. Congress passed the Prescription Drug User Fee Act (PDUFA) in 1992 which imposed tight deadlines on the FDA. By 2004, the FDA reported to Congress that "drug-approval time has been cut almost in half" since PDUFA was introduced.
What does this mean to someone who is taking prescription drugs, and in particular, a drug new to the marketplace? More serious side effects resulting in more serious injuries and more lawsuits against drug companies that do not have people's health and welfare as its priority.
Current deadlines to introduce a new drug now require reviews by the FDA to be completed within 10 months. Before PDUFA was introduced, a drug averaged more than 20 months and priority drugs, including high-risk drugs such as Celebrex and Zelnorm, need six month assessments.
One of the FDA's main problems may be due to the ever-increasing amount of new drugs on the market needing approval and Federal laws that allow pharmaceutical companies to submit as few as one clinical trial. And drug companies often just have to prove that its drug will work better than a placebo. According to [The New England Journal of Medicine ] in September, 2005 these minimal requirements would be "unacceptable anywhere else in research."
The 12 high-risk drug types identified by Consumer Reports are the following:
Celecoxib (Celebrex)
Estrogen alone (Premarin and others) or with progestin (Prempro and others)
Isotretinoin (Accutane)
Malathion (Ovide)
Medroxy-progesterone injections (Depo-Provera)
Mefloquine (Lariam)
Rosuvastatin (Crestor)
Salmeterol (Serevent)
Sibutramine (Meridia)
SSRIs such as sertraline (Zoloft), and other antidepressants such as venlafaxine (Effexor)
Tegaserod (Zelnorm)
Topical immuno-suppressants pimecrolimus (Elidel), tacrolimus (Protopic)
Of these 12 drugs, Elidel and Protopic were not issued black box warnings until March, 2005. Protopic (manufactured by Fujisawa) was approved in 2000 and Elidel (manufactured by Novartis) was approved in 2001 by the FDA to treat Eczema. Both drugs have been linked to a possible increased risk of cancer. In October 2005, neither drug company had made the change!
The following drugs have black box warnings and some have been discontinued:
Cisapride (Propulsid)
Medroxyprogesterone acetateDepo-:Provera
Etanercept (Enbrel)
Estrogens (Premarin)
Fentanyl (Duragesic)
Flutamide (Eulexin)
Fluticasone/Salmeterol (Advair Diskus)
Leothroxine (Synthroid)
Methylphenidate (Concerta)
Nefazodone (Serzone)
Oxycodone (OxyContin)
Pemoline (Cylert)
Pimozide (Orap)
Trovafloxacin/Altrovafloxacin (Trovan)