The Saudi Food and Drug Authority (SFDA) has canceled the registration of Ritrodine (Yutopar), which is used to stop premature labor. The move came following the recommendation of the commission in charge of the registration of approved pharmaceutical companies and products, as the medication was found to have serious side effects including cardiac arrhythmias, myocardial ischemia, pulmonary edema, palpitation and tachycardia. The commission has asked health practioners and health care providers to discontinue using the drug and use other medicines suitable for pregnant women who need to stop premature labor. In addition, it has contacted the authorities to remove the drug from the Saudi market and requested health practitioners to report any undesirable side effects of any drug to NPC.Drug@sfda.gov.sa. Meanwhile, the SFDA recently announced that there are 1,098 unlicensed companies that import medical equipment into the Kingdom. The number of local companies that import medical equipment across the Kingdom is 1,679, but only 581 of them are licensed. The rest of the companies import equipment without authorization, said Saleh Al-Tayyar, vice executive president for medical devices sector in the SFDA. The SFDA received more than 10,000 notifications about faulty equipment since 2008 and rejected around 1.24 percent of medical … Continue reading →

By Matthew Perone, The Associated Press Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking. The Food and Drug Administration on Monday released its review of the company's sleep aid, suvorexant, ahead of a public meeting on Wednesday. The pill works by temporarily blocking chemical messengers that keep people awake. The FDA said company trials show suvorexant is better than placebo at helping people fall asleep and stay asleep. And regulators said the drug's effectiveness was consistent across several doses tested by Merck & Co. Inc. But patients taking the higher doses of the drug showed an eight-fold increase in daytime drowsiness, which sometimes interfered with driving the next morning. Patients taking 20 milligrams and 40 milligrams of suvorexant had trouble staying in their driving lanes when tested by company researchers. FDA notes that four women actually had to stop the driving test due to excessive sleepiness. The FDA review also notes that suvorexant was associated with increased risk of suicidal thinking. Over 12 months, there were eight cases of suicidal thinking or behavior reported among patients taking the drug, compared … Continue reading →

MATTHEW PERRONE , The Associated Press Posted: Monday, May 20, 2013, 11:53 AM WASHINGTON - Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking. The Food and Drug Administration on Monday released its review of the company's sleep aid, suvorexant, ahead of a public meeting on Wednesday. The pill works by temporarily blocking chemical messengers that keep people awake. The FDA said company trials show suvorexant is better than placebo at helping people fall asleep and stay asleep. And regulators said the drug's effectiveness was consistent across several doses tested by Merck & Co. Inc. But patients taking the higher doses of the drug showed an eight-fold increase in daytime drowsiness, which sometimes interfered with driving the next morning. Patients taking 20 milligrams and 40 milligrams of suvorexant had trouble staying in their driving lanes when tested by company researchers. FDA notes that four women actually had to stop the driving test due to excessive sleepiness. The FDA review also notes that suvorexant was associated with increased risk of suicidal thinking. Over 12 months, there were eight cases of suicidal thinking … Continue reading →

By Matthew Perone, The Associated Press Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking. The Food and Drug Administration on Monday released its review of the company's sleep aid, suvorexant, ahead of a public meeting on Wednesday. The pill works by temporarily blocking chemical messengers that keep people awake. The FDA said company trials show suvorexant is better than placebo at helping people fall asleep and stay asleep. And regulators said the drug's effectiveness was consistent across several doses tested by Merck & Co. Inc. But patients taking the higher doses of the drug showed an eight-fold increase in daytime drowsiness, which sometimes interfered with driving the next morning. Patients taking 20 milligrams and 40 milligrams of suvorexant had trouble staying in their driving lanes when tested by company researchers. FDA notes that four women actually had to stop the driving test due to excessive sleepiness. The FDA review also notes that suvorexant was associated with increased risk of suicidal thinking. Over 12 months, there were eight cases of suicidal thinking or behavior reported among patients taking the drug, compared … Continue reading →

May 20, 2013 A new study of both computer-created and natural proteins suggests that the number of unique pockets -- sites where small molecule pharmaceutical compounds can bind to proteins -- is surprisingly small, meaning drug side effects may be impossible to avoid. The study also found that the fundamental biochemical processes needed for life could have been enabled by the simple physics of protein folding. Studying a set of artificial proteins and comparing them to natural proteins, researchers at the Georgia Institute of Technology have concluded that there may be no more than about 500 unique protein pocket configurations that serve as binding sites for small molecule ligands. Therefore, the likelihood that a molecule intended for one protein target will also bind with an unintended target is significant, said Jeffrey Skolnick a professor in the School of Biology at Georgia Tech. "Our study provides a rationalization for why a lot of drugs have significant side effects -- because that is intrinsic to the process," said Skolnick. "There are only a relatively small number of different ligand binding pockets. The likelihood of having geometry in an amino acid composition that will bind the same ligand turns out to be much … Continue reading →