Congress has passed legislation giving the FDA new powers of oversight concerning the pharmaceutical industry including more authority to require changes to drug labels, demand additional safety studies and limit the distribution of medications when safety concerns arise. The new legislation includes an interesting twist in that it may limit protection of pharmaceutical companies for drugs that...
Ketek, an antibiotic used for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, tonsillitis, or pharyngitis, has been shown to cause severe liver injury. Health Canada, in its September 2007 edition, has documented the risk of liver damage for users of the drug. The FDA should recall Ketek as a dangerous drug. Its risks significantly outweigh its...
The FDA has published a final rule establishing good manufacturing requirements for the manufacturers of supplements. The rule requires that all supplement manufacturers evaluate the identity, purity, quality, strength, and composition of dietary supplements. In addition, they are required to provide accurate labeling information on all their products. The FDA ruling is supposed to protect...
A jury in Bartow Florida awarded the family of a cancer patient $28.5 million who was given the wrong prescription, suffered a stroke, and subsequently died. According to the Associated Press article, "Beth Hippely was prescribed Warfarin, a blood thinner, in 2002 to treat breast cancer. The prescription filled at a Walgreens pharmacy was 10 times what her doctor prescribed, court documents...
The FDA will convene a panel to review the safety and efficacy of over the counter children's cold medicines. A group of doctors are pushing the FDA to put a warning on these over the counter products that they have not been proven safe and effective for children under six years of age. The petition was filed with the FDA earlier this year after a Centers for Disease Control and Prevention...
After two people died, Novartis AG has pulled its pain relief drug Prexige from the market in Australia. According to a story published in the Wall St. Journal, "Australia's Therapeutic Goods Administration said it had received eight reports of serious liver reactions in patients taking the drug. "It seems that the longer people are on the medicine, the greater the chance of liver injury," its...
Purdue Pharma L.P., the manufacturer of the popular Oxycontin, has been ordered to pay the stiff penalty of $634.5 million fine for misleading the public regarding the drug's addiction risk. In a Boston Globe article,the drug is "designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected. From 1996 to...
Eli Lilly, the manufacturer of the drug Zyprexa, may face more legal troubles after the FDA told the company it would delay the approval of its new drug Symbyax for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label. Symbyax combines Lilly's antipsychotic pill Zyprexa and the antidepressant Prozac. Zyprexa has...
Amgen was a rising star in the pharmaceutical industry until serious questions arose about the safety of two of its biggest selling drugs which treat anemia in cancer and kidney-failure patients. A black-box warning placed March 9 on the labels of those and other anemia drugs urges doctors to use the smallest possible dose of the drugs. The two anemia drugs, Epogen and Aranesp make up almost...
Two studies linking the Parkinson's drug Permax with heart valve damage have resulted in Valeant Pharmaceuticals International pulling the once popular drug from the market. The FDA had asked the drug manufacturer to discontinue marketing the product after the heart valve injury studies. If you are taking or have taken Permax for Parkinson's disease, you should consult your physician for...
