According to an April 21 AP article, the FDA issued a warning Monday to Changzhou SPL, the company that manufactures the blood-thinning drug Heparin. The FDA informed the pharmaceutical manufacturing company that it is not doing an adequate job of removing impurities from the raw materials it uses. However, the company maintains that it does employ safe manufacturing practices.

In recent months, the FDA has recorded 62 deaths from allergic reactions to Heparin.

The AP article states that “the FDA can’t say for sure what caused the reactions, but the chief suspect is a contaminant that the agency discovered in supplies of raw heparin coming from China — a compound derived from animal cartilage that so closely mimics heparin that routine purity tests can’t detect it.”

I’ve known several people who have taken Heparin in the last year, and it is definitely disturbing to think about what little control we have over the drugs we put in our body. We generally know very little about where they come from, what ingredients they contain and how they are made. And while the FDA does the best job it can to regulate, it seems that ultimately, it is impossible to keep track of so many drugs, ingredients and manufacturing companies.

I decided to do some research and find out the names of some of the latest drugs to arrive on the scene in so far this month. Here’s what I discovered (courtesy of Drugs.com):

• Treximet, formerly Trexima, is sumatriptan succinate and naproxen sodium. It is being developed as a novel combination of sumatriptan succinate and naproxen sodium in a single tablet for the acute treatment of migraine headaches. It was approved by the FDA on April 15.
• Patanase is olopatadine hydrochloride, a nasal spray designed to treat symptoms of seasonal allergic rhinitis in adults and children ages 12 and older. It was approved by the FDA on April 15.
• Lexiscan, or regadenoson, is an injection that acts as a Pharmacologic Stress Agent in Radionuclide Myocardial Perfusion Imaging (MPI), which is a test that detects and characterizes coronary artery disease, in patients unable to undergo adequate exercise stress. It was approved by the FDA on April 10.
• Rotarix an oral, two-dose, live attenuated vaccine for the prevention of rotavirus gastroenteritis in children, was approved by the FDA on April 3.

And perhaps more interesting, are some of the possible side effects of these drugs. I selected a few choice excerpts as the side effect and drug interaction disclaimers were rather lengthy and convoluted.

• Treximet may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Treximet contains a non- steroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. Treximet is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes and in patients with other significant underlying cardiovascular diseases. Treximet should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation. Treximet should not be given to patients with uncontrolled hypertension because the components have been shown to increase blood pressure…
• Patanase may cause bitter taste, headache, epistaxis, pharyngolaryngeal pain, post-nasal drip, cough, and urinary tract infection.
• Lexiscan may cause fatal cardiac arrest, life threatening ventricular arrhythmias, or myocardial infarction may be induced by pharmacologic stress agents. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan.
• Rotarix may cause crying, fussing, cough, runny nose, fever, loss of appetite and vomiting.

I have no doubt that these medications all have valid and commendable applications, but I always think it’s important to remind people to read the fine print. I also think it’s worth noting that four new drugs were approved in just under two weeks… so for better or worse, newcomer pharmaceuticals are making an entrance at a steady and rapid clip.