FDA Approves Generic Capsule Form of HIV/AIDS Drug
The first generic HIV/AIDS drug in capsule form for the U.S. market has been approved by the Food and Drug Administration. The same drug, zidovudine, already had approval in tablet and oral dosage forms.
The approval of the capsule form of the drug, made by Aurobindo Pharma in India, follows the expiration of GlaxoSmithKline's patent on Retrovir, its brand name form of zidovudine, the FDA said.
"This is a significant generic approval," Dr. Andrew C. von Eschenbach, acting commissioner of the FDA, said in a prepared statement.
"Retrovir, which was initially approved in March, 1987, was the first of a group of breakthrough medications that have transformed what was then a disease with a very dismal prognosis into one with a much more hopeful prognosis. Approval of this additional dosage form of zidovudine should help reduce the cost of this therapy for American patients," von Eschenbach said.
Group Wants Most Consumer Warnings Removed From Drug Ads
A coalition of advertising and public relations groups wants U.S. federal regulators to remove most of the consumer warnings contained in prescription drug ads.
In a petition submitted Friday to the Food and Drug Administration, the Coalition for Healthcare Communication said current prescription drug ads directed at consumers "overwarn and underinform," which results in, "more confusion than communication," the Associated Press reported.
The coalition, which receives some funding from drug companies, represents trade associations that specialize in medical advertising, communications, marketing and publishing.
"Our goal is simpler, clear messages that communicate both the risks and benefits of prescription medicines, more informed doctor-patient dialogue and improved patient compliance," John Kamp, executive director of the coalition, told the AP.
However, a consumer advocate said the coalition is off the mark. Consumer drug ads should contain clearer, not less, information.
"To pull away or remove those fine details, we are against that. I guess we are saying, 'more is better,'" Bill Vaughn, a senior policy analyst at Consumers Union, told the AP.
Companies Sued Over Sun Lotions' Effectiveness
A class action lawsuit launched in Los Angeles against the five leading U.S. makers of sun protection lotions alleges that the companies lied about the effectiveness of their products in blocking harmful sun rays and protecting skin.
The lawsuit names the following brands: Coppertone (Schering-Plough); Banana Boat (Sun Pharmaceuticals and Playtex Products); Hawaiian Tropic (Tanning Research Laboratories); Neutrogena (Neutrogena Corp. and Johnson & Johnson); and Bullfrog (Chattem Inc.).
Combined, they account for 70 percent of U.S. sales of such products, Agence France Presse reported.
Mitchell Twersky, one of the lawyers involved in the legal action, said claims by these brands are "clearly misleading" insofar as they claim that "their products block all the harmful sun rays."
The lawsuit seeks to have words such as "sunblock" and "waterproof" taken off the labels of these products. It also wants the companies that make them to direct "the money that they wrongfully obtained" into a skin cancer research foundation, AFP reported.
Child's Death, Injuries Prompt Recall of Toy Building Kits
A recall of 3.8 million Magnetix toy building kits was announced by the U.S. Consumer Product Safety Commission (CPSC) after one child died and four others suffered serious injuries from swallowing or inhaling tiny magnets used in the kits.
Overall, the CPSC has received reports of 34 incidents involving the tiny magnets in the Magnetic kits, including the X-treme Combo, Micro and Extreme versions, the Associated Press reported.
The magnets are fitted inside the toy's plastic building pieces and rods but can fall out.
The CPSC said a 20-month-old boy died after he swallowed magnets from a Magnetix kit. The magnets twisted his small intestine and caused a blockage. Three other children who swallowed magnets suffered intestinal perforations, had to have surgery and were hospitalized in intensive care.
Another case involved a five-year-old boy who inhaled two magnets that had to be surgically removed from his lungs, the AP reported.
The toys were sold across the United States at a number of stores, including Wal-Mart, Target and Toys R Us. The toys were made in China and imported by RoseArt Industries Inc.
Consumers should immediately take the toys away from children and return them to RoseArt for a full refund, the CPSC said. Contact RoseArt at 1-800-272-9667 or go to the company's Web site at www.roseart.com.
Gene Mutation Linked to Epilepsy
A genetic cause of epilepsy has been identified by U.S. researchers and the discovery could lead to the development of new medicines to treat both epilepsy and autism.
The researchers found a mutation that causes a gene to abnormally produce a protein called CASPR2, which they determined plays an important role in early human brain development, the Associated Press reported.
The genetic mutation was found in Amish children in Pennsylvania who have an epileptic disorder. All the children developed relatively normally until they started to experience frequent seizures in early childhood.
These children later experienced language regression and other characteristics of autism. This suggests that the gene mutation plays a role in autism as well, the AP reported.
The findings appear in the New England Journal of Medicine.
2 Million People Blinded by Preventable Eye Disease: WHO
A lack of resources means that about two million people in developing nations are blind due to trachoma, a disease that is easily preventable.
The disease affects about 70 million people, says the World Health Organization. Trachoma vanished from the United States and Europe as living conditions improved, but the disease still plagues much of Africa and parts of Latin America and Asia, The New York Times reported.
Trachoma can be spread from person to person or by flies that feed from seeping eyes. Eye damage caused by the disease builds up over decades of repeated infections. This recurring eye damage eventually leads to blindness.
A simple eyelid operation can prevent eye damage caused by trachoma, which can be controlled by antibiotics and improvements in hygiene. However, finding enough money or health workers to deal with trachoma is difficult in countries that also have to cope with other major health issues such as HIV/AIDS, malaria and tuberculosis, The Times reported.
Food Fact:
Snacking is a must!
By changing the way you snack, you may make it easier to lose weight. Eating something every 3 - 4 hours sustains energy, helps build a day's worth of good nutrition, and prevents hunger that may lead to overeating. Stock your desk with the right stuff: Ready-to-eat whole-grain cereal; single-serving microwave popcorn, fruit juices or low-fat pudding; vanilla wafers, fig bars or ginger snaps without hydrogenated oils; instant oatmeal; applesauce; canned fruit (in its own juice).
Fitness Tip of the day:
Fitting in fitness.
Going on a business trip? Make a pact with yourself to exercise -- it's easy when you plan ahead. Before you leave on your next trip, call health clubs in the area you'll be visiting and find one that offers a day pass. Ask the hotel concierge to suggest safe running/walking routes near your hotel, and maybe provide maps. Or, simply walk to a room on a higher floor, and you won't need to reserve a stair climber in the gym.
FAQ of the day:
What are the best non-dairy sources of calcium?
If you're looking for good non-dairy sources of calcium, try kale, red kidney beans, figs, almonds, calcium-fortified breads and breakfast cereals, calcium-fortified orange juice, and tofu processed with calcium sulfate.
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