1. FDA Calls for Simvastatin Limits
The FDA played a role in most of this year’s top news stories, starting with a June 8 recommendation that physicians restrict prescribing high doses of the cholesterol medication simvastatin (Zocor, Merck) because of a risk for muscle damage. The FDA drug safety communication states that physicians should limit using the 80-mg dose of simvastatin unless the patient has already been taking the drug for 12 months and there is no evidence of myopathy.
In addition, the FDA required that the label include the new dosing recommendations, as well as warnings not to use the drug with various medications, including itraconazole (Sporanox, Janssen Pharmaceuticals), ketoconazole (Nizoral, Ortho-McNeil Pharmaceutical), posaconazole (Noxafil, Merck), erythromycin, clarithromycin, telithromycin (Ketek, sanofi-aventis), HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, and danazol.
In addition, the 10-mg dose should not be exceeded in patients taking amiodarone, verapamil, and diltiazem, and the 20-mg dose should not be exceeded when taken with amlodipine (Norvasc, Pfizer) and ranolazine (Ranexa, Gilead).
2. FDA Warns of Methylene Blue and Linezolid Serotonin Interactions
Then, on July 26, the FDA warned against the use of methylene blue or linezolid with serotonergic drugs. In particular, the FDA said in an October 21 update that clinicians should watch out for interactions with serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors.
Methylene blue is a dye used in diagnostic procedures and in the treatment of conditions ranging from cyanide poisoning to methemoglobinemia. Linezolid is an antibacterial agent.
Both drugs inhibit the action of monoamine oxidase A, an enzyme that breaks down serotonin and can cause high levels of the neurotransmitter to build up in patients taking serotonergic agents, leading to serotonin syndrome.
Signs and symptoms include confusion, hyperactivity, memory problems, and other mental changes; muscle twitching, excessive sweating, shivering, or shaking; diarrhea; trouble with coordination; and fever. In the case of linezolid, some deaths have been reported.
3. WHO Calls Cell Phones Possibly Carcinogenic
The World Health Organization (WHO) stirred controversy in the third biggest story of the year when it announced in May that radiation from cell phones can possibly cause cancer.
The announcement was based on an extensive review of studies on cell phone safety by a working group of 31 scientists from 14 countries, who met regularly to evaluate the potential carcinogenic hazards from exposure to radiofrequency electromagnetic fields. They reviewed exposure data, studies of cancer in humans and experimental animal models, and other relevant data.
Study results have been inconsistent. Some of the strongest evidence supporting a link between brain tumors and cell phone use comes from a series of Swedish studies showing that risk increased with the number of cumulative hours of use, higher radiated power, and length of cell phone use.
They also reported that younger users had a higher risk.
The controversy continued when a different study, published in the July 27 issue of theJournal of the National Cancer Institute (2011;103:1264-1276), found that children and adolescents who use cell phones did not appear to be at a higher risk for brain cancer. Critics later lambasted the authors’ interpretation of the data, which they said actually showed a risk for cancer in this population. They noted that the study was funded by cell phone companies.
Another study that tended to exonerate cell phones, published online October 20 in the BMJ, drew a similarly fierce critique from the organization ElectromagneticHealth.org.
4. “Bath Salt” Street Drugs Temporarily Banned
The US Drug Enforcement Administration (DEA) claimed headlines as well, with atemporary ban, announced September 7, on 3 synthetic stimulants marketed as “bath salts” and “plant food” that mimic cocaine, LSD, MDMA, or methamphetamine when ingested.
According to a DEA news release, the emergency measure makes it illegal to possess or sell 3,4,methylenedioxypyrovalerone, mephedrone, and methylone for at least 1 year, with the possibility of a 6-month extension.
The chemicals have been the subject of an increasing number of reports from poison control centers, hospitals, and police during the last 6 months.
Marketed under names such as “Ivory Wave,” “Purple Wave,” “Vanilla Sky,” or “Bliss” in retail stores, head shops, and over the Internet, the chemicals can cause impaired perception, reduced motor control, disorientation, extreme paranoia, and violent episodes. Long-term effects remain unknown, officials said.
Earlier in the year, the DEA banned 5 chemicals (JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol) found in fake marijuana that was marketed as herbal incense or smoking blends under such names as “Spice,” “K2,” “Blaze,” and “Red X Dawn.”
5. FDA Approves New Drug for Type 2 Diabetes
In the 1 upbeat story on the list, the FDA on May 2 approved linagliptin (Tradjenta, Eli Lilly Co and Boehringer Ingelheim Pharmaceuticals) for improving blood glucose control in adults with type 2 diabetes, either as a stand-alone treatment or in combination with other therapies.
Linagliptin, which comes in tablet form, boosts the level of hormones that stimulate the release of insulin after a meal by blocking an enzyme called dipeptidyl peptidase-4.
Eight double-blind, placebo-controlled clinical trials demonstrated that the drug is safe and effective in patients with type 2 diabetes, the FDA said.
The drug has been studied as a stand-alone treatment and in combination with other type 2 diabetes therapies, such as metformin, glimepiride (Amaryl, Accord Healthcare), and pioglitazone (Actos, Takeda Pharmaceuticals). However, the combination of linagliptin and insulin has not been studied.
— Laird Harrison
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