Public Citizen calls on FDA to strengthen Botox warning
WASHINGTON A health advocacy group has filed a petition with the Food and Drug Administration after discovering that Botox and a similar drug Myobloc have been linked with 16 deaths and a large amount of serious injuries that occurred after the drugs spread to vital organs, according to The New York Times.
The group, Public Citizen, says that the drugs, which are used to relax muscles, should come with a far stronger warning label and patients should be given a letter detailing their risks.
Executives at Allergan, the maker of Botox, issued a statement saying that adverse reactions were rare. And because many patients who get the drug are seriously ill, the company said, it is not proved that Botox caused the reactions. Solstice Neurosciences, who make Myobloc, did not comment on the matter.
Botox is best known for removing wrinkles, but it is also approved to treat knotting of neck muscles, known as cervical dystonia. Doctors can relieve the pain from this for weeks or months when the drug is injected into multiple spots on the neck.
According to Public Citizen, the injection sites can sometimes be so close to the esophagus that it causes partial paralysis and aspiration pneumonia.
The group wants the drug labels to have a prominent section titles “special warnings and precautions for use” and would also like patients to receive a leaflet with warnings about the drugs, like there are on the drugs in Europe.
Harvard program seeks to discourage doctors from prescribing pediatric antibiotics
CAMBRIDGE, Mass. A program was conducted at the Harvard Medical School in an effort to change doctors’ prescribing habits for antibiotics and to educate parents of small children about the proper use of antibiotics, according to Reuters.
The program was initiated because of the emergence of microbes that are resistant to antibiotics because doctors prescribed the medications when they weren’t really needed.
Harvard Medical School’s Jonathan Finkelstein and colleagues conducted the program in 16 Massachusetts communities between 1988 and 2003. Finkelstein’s team measured changes in antibiotic prescribing rates among three groups of children: 3 to 24 months, 24 to 48 months, and 48 to 72 months.
By the end of the study, the intervention had not changed the rate of antibiotic use in the youngest group, but for children between 24 and 48 months, the rates decreased by 4.2 percent and for the oldest children, the rates decreased by 6.7 percent.
Patent office rejects Gilead patents for Viread
WASHINGTON The Patent and Trademark Office has tentatively rejected four patents for Gilead Sciences’ HIV drug Viread, according to published reports.
The Public Patent Foundation filed a petition in March seeking to revoke the patents for the drug because they felt the drug should never have been patented in the first place, as the technology used to make the drug had been previously disclosed publicly.
The PTO is now re-examining the patents. Industry experts have said that it is common for the federal agency to tentatively rule patents invalid after having been asked by a third party to re-examine them. What would be unlikely would be the patents being permanently revoked, which has only occurred about 10 percent of the time.
Gilead sells Viread under that name and in combination with other drugs as Truvada and Atripla. Taken together, the three HIV treatments generated $3.1 billion in sales last year, according to the company.